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Research Nurse Coordinator KU Medical Center
Position Summary Provides professional nursing care and patient monitoring for the Cardiovascular Research Institute's clinical trials, following established standards and practices. Assists in the preparation and submission of new research protocols. Responsible for patient recruitment, procedures and follow-up in the assigned clinical trials completion and retention of study documentation.
Key Roles and Responsibilities:
Reviews and assists with editing of new protocols. Assesses feasibility of research protocol including appropriate patient population, budget and specific needs for the study.
Performs all details necessary for initiation and/or completion of all assigned research protocols, including patient recruitment, screening, scheduling, enrollment, examination, laboratory and diagnostic studies, medication dispensing, charting and recording of data (both in EMR and case report forms), organization of the study visits and reporting of abnormal results, adverse events or other study required reporting.
Acts as a liaison between study sponsors and investigators.
Maintains accurate recording of all study test articles. Maintains complete and accurate documented studies in binders.
Maintains knowledge of all research efforts conducted including those protocols or studies assigned to other coordinators. Worth with KURI and other departments to construct the study package to include: budget, approved protocol, procedures, discounts, billing, study contracts and other related documents and workflows. Maintains current KURI-required education, i.e., Human Subjects Protection, HIPAA.
Adheres to GCP guidelines. Promotes marketing, in accordance with HSC rules, and research protocols.
Monitors awarded grants and contracts for compliance with performance, reporting and accounting requirements.
Attends all staff meetings as well as meetings both on site and off-site as required by study. Serves as mentor for new staff members. Required Qualifications
Must have current RN license plus a Bachelor's degree in a basic science or related field. Relevant experience may be substituted for the degree requirement on a year for year basis. Preferred Qualifications
Technical or professional training in nursing, ACLS, BCLS, KS & MO licenses, competencies required-age-specific care. Cardiovascular background.
Please apply online: https://jobs.kumc.edu/applicants/Central?quickFind=181704
KUMC is an AA/EO Employer and does not discriminate on the basis of sex, including marital status, race/ethnicity, color, age, sexual orientation, gender expression, gender identity, national origin, creed, religion, ancestry, disability status as a Vietnam-era veteran, special disabled veteran, recently separated veteran or other protected veteran, or genetic testing and screening information.
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. In Quintiles' Phase I Clinic, research studies are conducted each year that identify the medicines that will help people live happier and healthier lives. The medical professional who provides care and support for study volunteers are at the forefront of drug development. It's work worth doing.
We currently have an exciting career opportunity for a Clinical Research Nurse II working the night shift, three 12-hour shifts per week. Variable schedule to include holidays.
In this position, you will coordinate and participate in Phase I clinical research studies ensuring that studies are carried out according to protocol, standard operating procedures, and applicable guidelines and regulations. In addition, you will assist with the guidance and supervision of staff in this role.
Additional responsibilities may include:
Coordinate and participate in clinical research studies conducted by a supervising investigator to ensure that data collected on study volunteers adhere to study protocol; may assist in screening volunteers for inclusion in study based on pre-determined criteria.
Administer investigational drugs to volunteers according to study protocol.
Confer with volunteers to explain purpose of study and obtain informed consent forms; explain procedures and practical issues such as timelines for visits and restrictions on food and drink.
Record volunteer clinical data in case report forms (CRFs). Collaborate closely with study investigator informing on relevant adverse events and serious adverse events according to procedures outlined in the protocol.
Review CRFs; evaluate and interpret collected data and prepare protocol summary forms, statistical reports and analyses documenting progress, adverse trends and appropriate recommendations or conclusions.
Cooperate with study monitor and reserve sufficient time for questions during monitoring.
Participate in project meetings with clients and other members of the project team as needed.
Manage the unit after hours in the absence of senior staff, escalating problems to senior staff as required. Qualifications
Bachelor's degree or educational equivalent in Nursing and 3 years relevant experience; or equivalent combination of education, training and experience
Must possess a current RN license in the State of Kansas
Good knowledge of Phase I clinical trials
In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules
Knowledge of Microsoft Office Products
To apply, please click here to visit the Quintiles web site.
St. Francis Health Center is looking for a research assistant.
Bachelors degree required
The Research Assistant is responsible for assisting our Physicians and Medical Research Associates with cardiology and/or cancer research studies as assigned. The Research Assistant is responsible for assisting with: identifying, enrolling & following participants as required per protocol; maintaining data capture systems, warehouses, trending data, regulatory materials (IRB); communicating with study sponsor, presentation of data and assisting with national data registries as needed. The Research Assistant will need to have a strong understanding of Microsoft office tools, and possess a clinical Cardiac background.
Candidates with prior clinical research experience preferred. Position reports to the Cardiovascular Service Line Director. BS degree in Nursing, Allied Health Science, biology, public health, statistics, or other health related field. Clinical Cardiac and/or Oncology experience preferred.
Interested candidates can apply via this link.
HARP is seeking bids for web-master/designer/host for HARP's website (www.harp-research.com). We would appreciate our HARP community soliciting proposals on the organization's behalf. While we are still receptive to receiving input from members with respect to the task list, we may not be able to accommodate substantive changes this fiscal year. Please note, these modifications and tasks listed below were generated from feedback from members.
If you know of an individual or business that would be interested, please have them forward a formal bid or request a clarifications on tasks to: President@HARP-Research.org.
The deadline for receipt of final bids is NLT March 30th!
Tasks:
1. Revise Job Posting section to include expiration dates and potential for searchable by key terms.
2. Secure registration for educational meetings including real-time tech support and password restore. Should include ability for registrant to obtain and print posted materials by web administrators and a definitive expiration date on materials posted.
3. Present cost-impact analysis for online payment system for meeting registration as well as annual membership dues.
4. Monthly maintenance fee for hosting as well as on-demand costs to address technical issues encountered by web administrators when updating online materials.
5. Can include costs to provide material update assistance as an alternative to organization leadership postings/maintenance.
a. Post articles and send out e-mail announcements, including job postings, conference announcements, meeting reminders, other HARP news and announcements as needed
b. Upload and manage conference materials; guard against the unauthorized release of such materials
c. Provide user support for conference registrants and HARP web site users, including login/download support, technical troubleshooting and interacting with technical personnel
d. Maintain membership information and guard against the unauthorized release of such information
6. Develop and maintain list-serves with opt-in/opt-out features
7. Adding an expiration date to articles that appear on the web site (Job postings are considered "articles")
8. Make the site's "Search" function more prominent
9. Add a secure membership database for the purpose of sending communication via e-mail or postal mail
10. Add mailing list capabilities, including sign-up and opt-out features
The University of Kansas School of Nursing offers an all online educational program entitled, "Research Clinical Trial Coordinator Program". A new cycle of classes begins this Fall. For more information contact HARP member:
Helen Schaag, RN, MSN, MA; Coordinator, Research Clinical Trial Coordinator Program; University of Kansas School of Nursing; 913-588-1882; HSchaag@kumc.edu
Correlative Lab Director
Summary: Manage all day-to-day activities in three correlative labs across KUMC campuses. Responsible for coordination of oncology clinical trial specimens, radiology data and supplies per protocol requirements. Perform all lab duties. Manage staff, direct all lab activitiies, communicate extensively with all project personnel and with study sponsors.
Requirements: Master's degree in biology, chemistry or related disciplines. Experience may substitute for degree on a year for year basis. At least 5 years lab management in support of clinical trials. Excellent phlebotomy and in-depth specimen handling knowledge. Previous experience in managing laboratory staff. Excellent time management.
Duties:
Come be a part of a clinical trial team with long-term growth potential. Kansas City Gastroenterology & Hepatology is looking for a clinical trial assistant with Phlebotomy experience.
In addition to phlebotomy duties for the practice and the clinical trial department, you will assist the study coordinators with workflow processes, database maintenance and management, and being a liaison with patients, drug companies, and lab vendors.
MUST HAVE PHLEBOTOMY EXPERIENCE/BLOOD PROCESSING EXPERIENCE
Specific duties include: Perform venipuncture on clinical trial patients and clinic patients. Process and ship blood specimens based on pre-established protocol guidelines and within lab company's system. Appropriate documentation and transmission in EHR for in-house tests. Daily preparation of lab kits. Liaison with lab companies to include troubleshooting system and coordinating pick-ups. Maintain and stocking clinical trial laboratory supplies and practice supplies in exam rooms. Monitor and amend lab compendium within EHR. Any other task the study coordinators or practice administrator deem necessary.
Please reply to this ad with your resume for consideration.
Location: Kansas City Brookside/Waldo Compensation: DOE Principals only. Recruiters, please don't contact this job poster. Please, no phone calls about this job! Please do not contact job poster about other services, products or commercial interests.
Send resume and cover letter to: Laurie Lynn at Kansas City Gastroenterology & Hepatology.
Position Title Data Analyst Job Req # 12-005Staff Location KCUMB, 1750 Independence Avenue, Kansas City, MO 64106 FLSA Class Exempt Employment Status Full Time Weekly Base Hours 40 Work Schedule
Job Summary
Under the supervision of the Director of Score 1 for Health the successful candidate will ensure optimal utilization and effectiveness of the Referral Tracking system; assist in the development and production of various Score 1 reports; ensure validity and accuracy of data; contribute to the advancement and enhancement of the Score 1 program; and supervise the activities of the temporary data entry pool.
Qualifications Bachelor's degree in business, statistics, or related field. Equivalent experience may substitute for education. Three years mining data. Demonstrated competency of data analysis, including prior experience with research methods and statistical analysis. Experience in writing SAS code necessary. Other data analysis software experience a plus. One year supervisory experience or serving in a leadership role required. Excellent oral and written communication skills. Excellent proofreading skills critical. Proficient in SAS with demonstrated competence in importing and exporting data between software applications, the Internet, and MS Office (Word, Excel and Access). Working knowledge and expertise graphing software programs. Proficient in working library databases and government resources essential. Must be detail-oriented. Must be able to work in a dynamic and fast-paced environment. Must have excellent time management skills, be able to work independently, productively, and with little to no supervision. Demonstrated ability to interact professionally and appropriately with school administrators and University staff
Interested applicants can apply via this link.
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
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.
Childrens 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:
