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Clinical Trial Assistant/ Sr CTA-1201201
Description
Quintiles helps improve healthcare worldwide by providing a broad range of professional services, information and partnering solutions to the pharmaceutical, biotechnology and healthcare industries. We conduct both US and Global trials in all therapeutic areas. In fact, Quintiles conducts more clinical trials than anyone else in the world. Become involved in work that improves the quality!
Quintiles is searching for a Clinical Trials Assistant for our Overland Park, KS office. The Clinical Trials Assistant (CTA) will support the clinical project team in the following areas:
Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The Phase I division of Quintiles has more depth of therapeutic expertise and a broader range of services than any other service provider. We conduct both US and Global trials in all therapeutic areas. In fact, Quintiles conducts more clinical trials than anyone else in the world. Become involved in work that improves the quality of life for people around the globe. We are seeking a Pharmacy Manager for our Phase I Unit in our Overland Park, Kansas facility. The Pharmacy Manager will manage the Pharmacy department staff, regulatory compliance, and pharmaceutical aspects of clinical studies including project management and client interaction. You will ensure that safety and quality standards are met on all studies. Specific responsibilities include: • Manage operational aspects of the Pharmacy facility in accordance with applicable guidelines and Standard Operating Procedures (SOPs), regulations and policies. Manage the department budget and ensure achievement of financial targets. Assist with the daily operations of the pharmacy. • Manage staff in accordance with organization's policies and applicable regulations. Manage Pharmacy contracts, service level, and, where applicable, technical agreements with clients, suppliers and subcontractors. • Contribute to the continuous improvement of department operations. Implement initiatives developed by senior management. • Lead activities in the drug preparation room/area ensuring compliance with regulatory requirements, applicable guidelines and SOPs. Prepare study drugs. Ensure study drug-related documentation is complete and available for archiving on completion of the study. Manage the safety and quality aspects of the pharmacy service offering. • Oversee compliance and documentation related to the receipt, storage, dispensing/accountability of both investigational clinical trial supplies and non-study drugs. Oversee the return of investigational clinical trial supplies to sponsor or their destruction. Prepare annual turnover reports as needed. • During project initiation, liaise closely with sponsor, project manager, and other project team members regarding pharmaceutical matters. Work closely with subcontractors needed for supply and preparation of investigational clinical trial products. Manage the development of the protocol for study drug preparation in agreement with the sponsor, the project manager and Quality Assurance. • Ensure that investigational clinical trial supplies are on site and that necessary documentation and authorizations are in place before the trial begins. Ensure that regulatory requirements for import and export of investigational clinical trial supplies are fulfilled. Perform packing and labeling of clinical supplies as needed. • Assist QA in the preparation of external sponsor audits and regulatory inspections. Respond to internal and external audit/inspection findings in relation to investigational products and drug preparation room/area. • Lead the development and/or implementation of initiatives related to the continuous improvement of departmental operations. • Maintain required certifications. Attend educational and training events as required. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES • In-depth knowledge of pharmaceutical principals and practices • Working knowledge of applicable Quality Assurance guidelines, i.e., Good Manufacturing Practices (GMP) • In-depth knowledge of applicable regulations • Working knowledge of drug development process • Excellent organizational skills • Excellent oral and written communication skills MINIMUM REQUIRED EDUCATION AND EXPERIENCE • Bachelor's degree or educational equivalent in Pharmacy and 6 years relevant experience including 2 years experience in a leadership capacity; or equivalent combination of education, training and experience • Applicable certifications and licenses as required by the State of Kansas To apply, please use the following link: Pharmacist / Study Medication Nurse (Pharmacy Manager)-1115773
Job Summary
Provide administrative and nursing support for clinical trials within the University of Kansas Medical Center, Division of Nephrology.
Required Qualifications
Bachelor's degree in Biology, Nursing or other health-related field. Experience may be substituted for a degree on a year for year basis. Must have CCRP certification upon hire or not later than one year after date of hire.
Preferred Qualifications
Experience in Nephrology or clinical trails, and individuals with an RN or LPN license are preferred.
Job Duties
Recruit eligible clinical research subjects with kidney disease following protocol guidelines. Obtain informed consent. Answer subjects' questions about the study. Execute informed consent procedures and verify completion of documents in conjunction with staff physicians. Schedule subjects for tests and procedures. Call test results to subjects and provide a thorough explanation. Communicate with subjects' personal physicians. Review records and forms for compliance with quality assurance guidelines. Perform consistency checks, edit for errors and monitor timelines for data submission. Gather records, reports and other materials for sponsor site visits. Review clinical trial proposals for feasibility. Negotiate terms with sponsor through Research Institute. Complete all mandatory training annually or as required. Perform other duties as assigned.
Note: KUMC accepts applications only via their online job system. Please visit http://jobs.kumc.edu and and search for position number J0010103 .
Job Details: Associates degree is preferred
Clinical Research Associates
PRA International is a global Clinical Research Organization based in Raleigh, NC. With approximately 4,000 employees worldwide and sites located across 85 different countries, we offer stability and excellent career advancement opportunity. We attribute our success in large part to our employees, and understand the importance of attracting, retaining and promoting the right people. PRA is an industry leader, and we provide competitive compensation and top-tier benefits in addition to a fantastic corporate culture. Due to continued growth at PRA, we are looking for experienced Clinical Research Associates nationwide. Qualifications include a BA/BS plus 2-5+ years’ experience as a regional CRA. Experience monitoring trials for CNS, Immunology, and/or Pain (Schedule II) indications are strongly preferred. If interested, please apply directly using the following link: https://sjobs.brassring.com/1033/ASP/TG/cim_jobdetail.asp?partnerid=185&siteid=5199&AReq=9753BR&Codes=WLI
Project Director
The University of Kansas Cancer Center is currently recruiting a Project Director. Responsibilities: Responsible for managing the smooth transition of studies, projects, or programs from conception/start-up to completion. Serve as primary liaison with sponsors and vendors; lead cross-functional teams; manage deliverables; oversee projects costs, contracts, agreements; and nurture external partnerships.
• Primary liaison with internal or external clients, sponsors, or partners for assigned studies, projects, or programs. Lead contact for all project matters; understand and manage contractual and organizational client expectations; nurture client relationship and needs. Provide to the client regular reports on project status, certain metrics, and issues. Plan, organize, and lead client meetings. Provide agendas and minutes for client meetings.
• Lead the cross-functional team involved in assigned studies, projects, or programs. Prepare the project plan for services to be provided including the communication plan. Help team members prioritize, solve problems, and plan contingencies. Delegate activities while retaining ownership. Communicate project findings and priorities. Liaise with upper management to optimize performance of project team members.
• Manage project deliverables. Supervise progress by keeping close metrics. Monitor time, quality, and cost. Prepare and lead presentations of internal project status to upper management, disease working groups, and team gatherings. Be accountable for follow-up on action items. Take the initiative in identifying, resolving, or escalating issues.
• In cooperation with project financial officer, monitor project costs and understand and be able to present financial review of the project. Aid in study budgetary preparation and resource planning needs to accomplish study objectives.
• In cooperation with quality control officer, monitor observance of departmental operational policies and guidelines.
• In cooperation with regulatory coordinators, organize and actively participate in sponsor/client site visits.
• Work closely with and mentor new members of the clinical project management team. Continually review project management processes to support early phase oncology clinical trials. Serve as an internal liaison to bridge projects from earlier preclinical project teams and their project managers to transition smoothly to clinical stages.
• Serve as first point of contact for potential outside clients. Be the face of the University of Kansas Medical Center and the Cancer Center. Requirements:
• Bachelor's degree in life sciences focused in pharmacology, pharmaceutics, or related field.
• At least 3 years clinical trial project management experience within the pharmaceutical industry or academia.
• Excellent interpersonal skills; strong oral and written communication skills; expert computer skills (e.g., with Microsoft products). Qualified candidates should apply at jobs.kumc.edu/applicants/Central?quickFind=181538. For further questions, you can contact Brian Noble at bnoble@kumc.edu. Feel free to visit the KU Cancer Center website at www.KUCancerCenter.org.
Phase I - QA Specialist
jobs.kumc.edu/applicants/Central?quickFind=181424
The University of Kansas Cancer Center is currently recruiting a Quality Assurance Specialist.
Responsibilities:
Position is responsible for developing audit plans based on the National Cancer Institute guidelines. Coordinates audits and site visits. Oversees reporting and resolution of compliance issues.
• Develop internal audit program including policies and procedures that can be utilized by members of the Quality Assurance team.
• Oversee and coordinate the Quality Assurance Program for the KU Cancer Center and the Midwest Cancer Alliance.
• Provide support and training for all involved in the Quality Assurance Program.
• Develop and recommend systems/indicators for audits of CTO clinical trials. Write and develop audit plans based on the National Cancer Institute's guidelines for national cooperative group audits.
• Evaluate results of audits, submit formal QA report and make recommendations to be disseminated to the Deputy Director of the KU Cancer Center, CTO Director, principal investigators and others impacted by these results.
• Conduct audits based on Data Safety Monitoring Board and Protocol Review Committee recommendations.
Requirements:
• Bachelor's degree in Business Administration or related field.
• Minimum of 5 years Quality Assurance experience.
• Effective organization, communication and leadership skills.
• Knowledge of word processing, spreadsheets and database applications.
Qualified candidates should apply at jobs.kumc.edu/applicants/Central?quickFind=181424. For further questions, you can contact Brian Noble at bnoble@kumc.edu. Feel free to visit our website at www.KUCancerCenter.org.
Phase I - Lab Manager
jobs.kumc.edu/applicants/Central?quickFind=181554
The University of Kansas Cancer Center is currently recruiting a Lab Manager.
Responsible for coordinating and obtaining oncology clinical trial specimens, radiology data, and supplies per protocol requirements. Perform all lab duties. Work with study team members to ensure study samples are obtained, handled, stored, and shipped according to protocol. Position will be based at The KU Clinical Research Center in Fairway.
• For each study protocol, have an in-depth knowledge of specimen collection, processing and shipping requirements. Accurately obtain, process and manage specimens from patients participating in Phase I clinical trials.
• Team function is key: collaborate with research and hospital nursing staff to secure and process specimens in a timely manner; collaborate with hospital laboratory and pathology departments to ensure samples are analyzed according to protocol; collaborate with tissue repository staff and ensure specimens and collected, stored, and delivered according to protocol.
• Travel between 3 medical center campuses (main campus, Westwood, Fairway) when necessary and be organized and prepared to perform all sample collection and processing in any of the 3 locations under direction of supervisor.
• Be trained and able to function in one or more areas of the clinical laboratory including: chemistry, flow cytometry, hematology, immunology, microbiology, molecular miology, virology, specimen collection and processing, cytology, surgical pathology.
• Ensure all requirements for specimen integrity have been met (positive patient identification, correct specimen collected, proper transport of sample has been employed, etc.). Recognize sources of error or inappropriate specimen collection and initiate corrective action when indicated. Assure the appropriate personnel have been contacted and the incident documented according to SOP's.
• Attend research meetings, department meetings, pre-study site visits, study initiation meetings, and close-out visits as requested by supervisor. Performs other duties as may be assigned by supervisor.
• Provide patient and/or care provider with accurate instructions and necessary materials if required, for specimen collection. Consistently recognize the importance of patient focused care utilizing customer service skills and techniques. Take the time to listen to and acknowledge the needs of patients, staff members, co-workers and visitors and make every attempt to be available to help. Respect the confidentiality of all patients.
• Accurately perform data entry in hospital and laboratory information systems according to policies and procedures, as well as compliance requirements. Accurately prepare, label and store specimen collection kits, reagents and patient specimens for analysis. Dispose of biohazardous materials, chemical waste, sharps and other potentially hazardous materials according to policy, and strictly adhere to safety and infection control procedures.
• Calibrate, maintain and operate equipment keeping appropriate documentation. Report malfunctions to supervisor. Maintain inventory of study lab kits and shipping materials. Participate in quality assurance/quality improvement activities related to specimen collection, specimen handling, processing and shipping, as well as patient preparation and identification.
• Bachelors degree with 4 years laboratory management experience in an experimental testing setting.
• Strong understanding of human anatomy and physiology and laboratory instrumentation.
• Strong computer and data entry skills.
• Phebotomy training.
• Complete HIPAA and Research Compliance Training.
Qualified candidates should apply at jobs.kumc.edu/applicants/Central?quickFind=181554. For further questions, you can contact Brian Noble at bnoble@kumc.edu. Feel free to visit our website at www.KUCancerCenter.org.
(Part-Time) Clinical Research Nurse
jobs.kumc.edu/applicants/Central?quickFind=181461
The University of Kansas Cancer Center is currently recruiting a Part-Time Research Nurse.
This individual will work 3 days a week within the KMCRI Clinical Trials Office providing oncology nursing research expertise and support across a multitude of ongoing research studies. They will also aid in the development of research protocols. This position will be a member of the KMCRI Protocol Review and Monitoring Committee which will require scientific review of oncology and oncology-related studies. This person would also be responsible for assisting with development of policies and procedures.
• Responsible for overall knowledge of protocols available from the Clinical Trials Office.
• Recruiting/Screening study patients. Maintain referral, screening and enrollment logs for each study.
• Responsible for working collaboratively with the physician and nurse clinician to determine what additional tests/procedures/specimens, etc. are standard of care and which are protocol specific and needed for patient registration (following consent).
• Responsible for ensuring that patients meet all inclusion/exclusion criteria. Enroll/Consent study patients (patient teaching as related to study and develop patient education materials and presents to patient and/or family members, and KUMC nurising staff). Original consent sent to responsible Coordinating office.
• Responsible for specimens deemed necessary for eligibility to be obtained and sent prior to enrollment. Will send appropriate documentation of such shipments to responsible coordinating office. Responsible for ensuring lab kits needed are available to the lab. Responsible for ensuring specimens are collected, processed and stored according to protocol requirements.
• Work closely with KUMC Nurse Clincians, Physicians, and KU Ancillary staff. Relay appropriate information regarding patient care to the collaborating physician. Conduct adverse event assessment and notify the responsible coordinating office for reporting (physician review and sign off on casualty, etc).
• Responsible for notifying pharmacy of changes in treatment due to a toxicity (in collaboration with physician). Monitor toxicities, dose modifications and treatment calculations. Provide research nursing follow-up for patient management clinical trial.
• Responsible for all data and source documentation. Provide clear comprehensive documentation of study visits while adhering to the specific protocol requirements as well as ICH/GCP guidelines.
• Maintain Protocol tab with current and relevant information in patient medical records.
Provide minimal data entry (to be assessed per study). Does minimal GOG data entry online. Responsible for registering patients for cooperative group trials.
• Serve on Protocol Review and Monitoring Committee. Evaluate new protocols in terms of nursing requirement and feasibility. Reviews potential protocols to evaluate their effect on standard nursing procedures.
• Attends study-related meetings, disease working group meetings and investigator initiation meetings which may require out of town travel.
• Bachelor's degree in nursing and current license to practice as a registered nurse in the state of Kansas.
• Minimum of 3 years oncology nursing experience.
• Previous experience in clinical trials.
• CPR certification and venipuncture skills needed.
Qualified candidates should apply at jobs.kumc.edu/applicants/Central?quickFind=181461 . For further questions, you can contact Brian Noble at bnoble@kumc.edu. Feel free to visit our website at www.KUCancerCenter.org.
Regulatory Affairs Coordinator -
jobs.kumc.edu/applicants/Central?quickFind=181383
The University of Kansas Cancer Center is currently recruiting a Regulatory Affairs Coordinator.
This position will be responsible for regulatory responsibilities related to cancer or cancer-related clinical research within the KU Cancer Center (KUCC). Position responsibilities will require excellent written and oral communication skills, excellent organizational skills, working knowledge of database software, demonstrated ability to work independently and collaboratively, and previous experience working in an academic medical setting or pharmaceutical company/contract research organization.
• Coordinate new protocol submissions for IRB review.
• Liaison between KUCC and sponsors of studies.
• Responsible for maintaining and filing all regulatory documentation to ensure protection of subjects and subjects' rights required for cancer clinical trials.
• Preparation of adverse event experience reports in absence of study nurse. Enter patient data into screening, eligibility, clinical management database and maintain database as needed.
• Assist in the preparation of materials for site visits by sponsors/monitoring committees. Prepare quarterly and annual reports to sponsors for clinical trials.
• Monitor patient enrollment in cancer clinical trials.
• Bachelor's degree in Biology or Nursing or related field. Experience may substitute for the degree on a year for year basis.
• Must possess excellent scientific data documentation skills (experience in protocol design and management preferred.)
• Highly literate in computer software related to preparation of documents and workings of data collection databases. Organized with excellent time-management skills.
Qualified candidates should apply at jobs.kumc.edu/applicants/Central?quickFind=181383. For further questions, you can contact Brian Noble at bnoble@kumc.edu. Feel free to visit our website at www.KUCancerCenter.org.
Entry Level Clinical Research Associate /Sr CRA / Kansas City/St. Louis (1116012)
Description:
The University of Kansas Hospital currently has an opening for a Trauma Burn Research Coordinator.
Children’s Mercy Hospital is looking for a full time Developmental Medicine Professional.
Job Responsibilities:
A small CRO in the KC region is looking for a Biostatistician to work on ophthalmology device trials.
This person will work closely with clinical research staff to determine appropriate study designs, sample size estimates, and write appropriate sections of study protocols. The position is also responsible for writing statistical analysis plans, analyzing data, writing manuscripts, and writing sections of clinical study reports and registration documents.
Additional responsibilities include:
The Business Unit : Early Development Services
PRA's Early Development Services (EDS) group, is one of the business units within PRA that provides comprehensive services such as Phase I and IIa clinical research, Bioanalytical research and Data support. PRA's facilities are located in the United States. Part of EDS is a Clinical Pharmacology Center in Lenexa, Kansas. In this clinic we research the effects and possible side effects of medicines. This is done with the help of volunteers both healthy people and patients. Research on humans is a mandatory step in the development of new drugs before they are marketed.
The role: Clinical Study Manager
A Clinical Study Manager (CSM) is part of the Project team and manages the preparation and study specific execution of a clinical study. As a CSM you make sure that the execution of studies is in accordance with the protocol and the internal procedures with due observance of the health and the well-being of the volunteers.
Kansas City Gastroenterology and Hepatology is looking for an experienced Full time (40 hour per week) study research coordinator to work in Brookside. Ideal candidate will have 2-3 years experience in a clinical trial environment.
Study Coordinator Job Description/Duties:
Knowledgeable in regulatory document completion and IRB submission procedures. Knowledgeable in laboratory specimen collection and processing. Able to obtain vital signs. Ability to read and understand clinical trial protocols. Detail oriented to correctly complete the requirements of clinical trial protocols. Knowledgeable in eCRF and paper CFR completion. Ability to professionally and appropriately interact and provide patient care. Ability to professionally and appropriately interact and work with sponsors and their delegates. Ability to identify subjects via chart review for participation in a clinical trial.
**MUST HAVE EXPERIENCE IN A CLINICAL TRIAL SETTING**
Location: RMC Brookside Campus Compensation: $14.18-$20.64/hr, DEO This is a full-time job. Interested candidates should e-mail their resume/CV to Chris Wertz at chris@digestivenet.com
Clinical Outcomes Analyst Oncimmune USA, LLC
Company Information
Oncimmune (USA) LLC, founded in 2006, is an industry leader in early cancer detection. Oncimmune (USA) LLC is a wholly-owned subsidiary of Oncimmune LTD based in Nottingham, England. The company is committed to advancing early cancer detection through proprietary autoantibody assay technologies based on biological technology. The company’s mission is to develop early cancer detection tests to identify more than 90 percent of solid-tumor cancers, which make up 70 percent of all cancers including lung, breast, colorectal, prostate, stomach, pancreatic and ovarian. As a lab service, Oncimmune’s laboratory is CLIA-certified under the Clinical Laboratory Improvements Amendment of 1988.
Job Description
We are currently seeking a Clinical Outcomes Analyst to coordinate and maintain clinical follow-up on patients that have had our blood test for early detection of lung cancer. You will be responsible for contacting physicians and their office staff to gather patient medical records as they relate to cancer diagnosis, as well as organizing, processing and presenting the data you obtain. In addition, you will work closely with the company’s Medical Consultants to address questions that may arise during the process. As a Consultant, you must have the ability to handle confidential information and comply with the Standard Operating Procedures (SOPs), GCP and HIPAA. This is a contract part-time position; some work may be completed from a home office.
• Telephoning, faxing, e-mailing physician offices; developing rapport with key clinical contacts to achieve follow-up objectives;
• Obtain, review, interpret and maintain medical records in accordance with established regulatory guidelines;
• Establish and maintain organized files for each patient (i.e. electronic and/or hardcopy);
• Read and interpret data from patient medical records;
• Enter data from patient medical records into spreadsheet and CRM database, preparing it for analysis;
• Analyze and summarize data;
• Prepare and present findings;
• Provide frequent updates on progress and issue clarification/resolution to management;
• Reviews the documentation of all data and information and assures that files and analyses are complete and accurate;
• Verify proper administration of informed consent and HIPAA release processes at physician offices;
• Responsible for meeting all deadlines and the reporting requirements;
• Performs miscellaneous clinical and non-clinical duties upon request as needed. Job Requirements
• A Bachelor degree in health science field or equivalent experience. Preference will be given to individuals with experience in oncology, radiology, pulmonology and/or nursing.
• Three years related experience required.
• Excellent interpersonal and communication skills, including demonstrated ability to effectively work with clients and colleagues.
• Demonstrated strengths in oral and written communications, including qualitative and analytical writing, editing and presentation skills as well as ability to handle multiple projects simultaneously.
• Self-starter that can employ a variety of resources to effectively accomplish jobs.
• Proven track record of meeting or exceeding project expectations and deadlines is required.
• Extensive knowledge of HIPAA and other regulations applicable to healthcare is required.
• Experience with standard data analysis and presentation methods.
• Experience with Microsoft office and CRM applications.
• Must be detail oriented.
• Oncology, radiology, pulmonology and/or nursing experience preferred.
• Ability to persist with tactfulness to accomplish a specific task.
• Ability to work independently.
• Proven supervisory and project management skills.
• Strong problem-solving abilities.
We seek individuals who are highly organized, self-motivated and detail-oriented, computer literate, able to work independently, with strong problem solving abilities and excellent written and verbal communication skills.
Compensation:
• Commensurate with experience
To apply please submit your resume and cover letter to HumanResources@oncimmune.com
No phone calls please.
Director, Clinical Trials Services PRL Central Laboratory Services ***This position is located in Overland Park, KS. Local candidates and those willing to relocate to the Kansas City metropolitan area are encouraged to apply*** You know where to lead and how to get there. You want authority, autonomy, and flexibility. Because client needs drive what you do, you get results and create change. You seek a different setting that truly gives you the chance to be the difference for the organization and the people who work for you. PRL Central Laboratory Services is the company for you. At PRL, our goal is to contribute exceptional value to clinical trials by satisfying client expectations and winning their confidence. With a driving quality focus, exceptional and evolving technical competencies, solid experience, stability, and proper credentials, PRL has the right capabilities for continued success. Director, Clinical Trials Services: Join PRL Central Laboratory Services and be a part of the leadership of a respected and unique organization. This senior management position will provide strategic leadership for PRL Central Laboratory Services business effectiveness. The individual in this position must be a flexible, solution-oriented team leader and contributor. The selected candidate will be responsible for directing the development and management of PRL’s capabilities for continued success as a clinical trials services provider. This is an opportunity to lead the team to achieve reliable, high quality performance, producing sustained customer satisfaction and loyalty. Top priorities will include organizing and executing delivery of the full scope of technical and logistical requirements in each clinical trial. You’ll enjoy generous salary and benefits and a highly rewarding work environment. Physicians Reference Laboratory LLC, has provided services for Phase I through Phase IV clinical studies since 1993. PRL is a private independent reference laboratory offering services in four business areas including clinical diagnostic testing, anatomic pathology, medical and forensic toxicology, and clinical trials. Since 1976, PRL consistently meets operations objectives and goals for growth, with uncompromising dedication to care and respect for the dignity of patients. PRL now employs nearly 500 professionals and staff. Requirements The qualified candidate for the Director, Clinical Trials Services position will possess the following: • Excellent business acumen and organizational knowledge with general management capabilities. • Functional knowledge and experience in the central laboratory services industry, with background in the clinical development industry preferred. • Comprehensive knowledge of central laboratory services and business process, associated quality systems and regulatory compliance requirements, and current CT data management standardization models and methods. Emphasis on documentation of effectiveness and process control. • Outstanding leadership, interpersonal, and communication skills. • Proven people, process, and project management skills with strong emphasis on quality and continuous improvement. • Ability to tend to the dynamic needs of varied clinical trials customers in order to balance detailed project execution and outcome deliverables. • Outstanding interpersonal and communication skills. For more information on PRL Central Laboratory Services and Physicians Reference Laboratory, please visit us online at http://www.atPRLweCare.com. To apply for this position please contact: Human Resources Physicians Reference Laboratory 7800 W. 110th Street Overland Park, KS 66210 Phone: (913) 338-4070 Fax: (913) 338-4245 Email: hr@prlnet.com Physicians Reference Laboratory is an Equal Opportunity Employer (EOE) and strongly supports diversity in the workplace. M/F/V/D.
Experience in Nephrology or clinical trails, and individuals with an RN or LPN license are preferred. Job Duties Recruit eligible clinical research subjects with kidney disease following protocol guidelines. Obtain informed consent. Answer subjects' questions about the study. Execute informed consent procedures and verify completion of documents in conjunction with staff physicians. Schedule subjects for tests and procedures. Call test results to subjects and provide a thorough explanation. Communicate with subjects' personal physicians. Review records and forms for compliance with quality assurance guidelines. Perform consistency checks, edit for errors and monitor timelines for data submission. Gather records, reports and other materials for sponsor site visits. Review clinical trial proposals for feasibility. Negotiate terms with sponsor through Research Institute. Complete all mandatory training annually or as required. Perform other duties as assigned.
Note: KUMC accepts applications only via their online job system. Please visit http://jobs.kumc.edu and and search for position number J0083398.
Hiring Department Research Services - Research Compliance Office
Department Overview/Comments: The UMKC Office of Research Services is comprised of four major subunits, including the Office of Research Compliance. Research Compliance under the new leadership of Chris Winders, Director, is responsible for administering and managing five compliance committees, including Adult Health IRB, Social Sciences IRB, IACUC, Institutional Biosafety, and Radiation Safety.
This Compliance Officer position is responsible for providing significant support and expertise, along with another IRB Compliance Officer, to two (2) Institutional Review Boards for the Protection of Human Subjects (IRB) committees for protocol submission, decision support, and compliance with regulatory standards for Federal laws, National standards, and Institutional Policy, by facilitating and administratively supporting these committees. Activities include participating in the protocol submission and review process; preparation of required federal and institutional reports; designing instructional materials to satisfy federal educational requirements of faculty, staff, and students; serving as one of the university's back-up points of contact with the appropriate state and federal regulatory bodies; formulating, interpreting, implementing, and ensuring compliance with policies and regulations.
Duties of the IRB Compliance Officer include, but are not limited to:
Truman Medical Center is looking for a Cardiology Clinical Research Coordinator.
If you share our passion for healthcare excellence, take your place among the best at Truman Medical Centers. Named one of the nation's top academic medical centers, TMC is the primary teaching hospital for the University of Missouri-Kansas City School of Health Sciences and is particularly distinguished for its care in asthma, bariatrics, diabetes, women's health, and trauma services. TMC is a two-hospital, combined 354-bed not-for-profit hospital, which is the largest and most comprehensive safety net healthcare provider in Kansas City, Missouri. As a comprehensive, multi-faceted, not-for-profit health care system, TMC serves all patient demographics, regardless of the ethnic or socioeconomic backgrounds.
The Cardiology Clinical Research Coordinator is responsible for performing diverse administrative and clinical responsibilities requiring some analysis, sound judgment, and a high level of knowledge of specific research study protocols, Good Clinical Practice Guidelines, Federal research regulations, and institutional requirements. Responsible for coordination and management of clinical study protocols and along with the research investigator, manages many aspects of the clinical trial and conducts all research activities within an ethically based framework in accordance with federal, state, and local regulations. Function as a liaison between investigators, subjects and sponsors, the Institution(s), Institutional Review Board (IRB) and Privacy Board.
Bachelor’s degree in allied health medical field or related field or licensed RN or LPN.
Ability to prioritize and complete several tasks/projects simultaneously in strict accordance with regulations, policies, and study protocol.
Demonstrated effective verbal/written communication skills, analytical skills, attention to details, and ability to work independently with minimal supervision.
Organization/time management skills and project management skills.
Demonstrated intermediate knowledge of personal computer skills.
Interested candidates should apply via the TMC Career Center at www.trumed.org.
This individual is responsible for the regulatory activities to support cancer clinical research within the KU Cancer Center (KUCC). This position will assure that all cancer clinical research is compliant with applicable federal, state or international requirements and the University of Kansas and other entities involved in the conduction of research at the KUCC. In addition, this position will be responsible guiding a protocol through the study start up process and measuring the metrics associated with starting a study.
Bachelor's degree in Biology, Nursing or other health-related field. Experience may substitute for degree on a year for year basis. Excellent written and oral communication skills and computer skills. Must have experience in regulatory support of clinical research.
Position responsibilities will require excellent written and oral communication skills, excellent organizational skills, working knowledge of database software, knowledge of medical terminology, demonstrated ability to work independently and collaboratively, and previous experience working in a health-care related setting.
Must be detail oriented and have proven ability to multi-task.
Master's degree in health-related field. Four or more years experience as a regulatory coordinator or involvement in the regulatory aspects of conducting clinical research. Ability to manage and create databases. SoCRA certified or SoCRA eligible
Interested Candidates should visit the the KUMC web site via the following link: jobs.kumc.edu/applicants/Central?quickFind=180714
Saint Luke’s Cancer Institute (SLCI) in Kansas City MO is seeking job candidates for two open oncology clinical research positions.
SLCI open positions include:
1) a Part Time Clinical Research Nurse / Coordinator, and
2) a PRN Clinical Research Nurse / Coordinator.
These positions encompass a range of responsibilities supporting study patients, for effective coordination of oncology clinical trials conducted by SLCI investigators.
Primary work activities may include but are not limited to: Study subject screening and eligibility assessment, participating in informed consent process with potential patients, coordinating protocol required procedures and assessments throughout the trial, facilitating work processes with other departments providing study services, compiling, recording and validating study data per protocol requirements, maintaining and appropriately documenting regular communications with sponsors and/or CROs.
Oncology clinical practice and treatment knowledge and / or experience preferred.
Interested applicants should apply online at: http://www.saintlukeshealthsystem.org.
Children's Mercy Hospital is looking for a Clinical Research Coordinator II (Full Time, Days M-F) at their Plaza location.
Applicants should submit an application via the CMH web site at http://www.childrens-mercy.org/careers/
Essential Duties include:
Required Qualifications:
The KUMC Research Institute offers a very competitive benefits package which includes medical and dental, vision, disability, flexible spending account, life insurance, 403(b) retirement plan, and a variety of other benefits programs.
For immediate consideration, apply on-line at http://kumc.iapplicants.com/
EOE/D/M/V
Aerotek is currently looking to hire several Drug Safety Professionals for their client in the Kansas City area. Ideal candidates will have an RN in state of MO or KS or PharmD/MD.
Review, assess and process data and information received from sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines.
Interested candidates should send their resume to Kelly at kschippe@aerotek.com
