This position works with faculty and staff to facilitate investigator-initiated and pharmaceutical-sponsored clinical trials, identify research problems and design hypotheses to be tested. The individual will be responsible for independently designing and implementing multiple research projects to test the hypotheses in human subjects and facilitate laboratory correlative work.
The Clinical Research Coordinator will have daily interaction with pharmaceutical sponsors, physicians, other health care personnel (e.g. nurses, patient care coordinators, insurance companies), and patients. The individual is also is required to use independent judgment, leadership and expert knowledge of the academic clinical trial healthcare operations to effectively facilitate the work flow and promote a collaborative work environment.
The position will maintain dynamic communication with the study investigators, research staff, numerous Fred Hutch, SCCA, and UW departments, federal agencies and industry partners. Additionally, the individual will be required to integrate information from multiple sources to ensure that all research proposals meet the requirements of Fred Hutch, the Food and Drug Administration, the National Institutes of Health and the study sponsor.
This position develops and implements procedures that ensure that all research meets or exceeds these requirements while expeditiously furthering the research objectives of the Sarcoma research team.
Finally, the Clinical Research Coordinator will interact with representatives from pharmaceutical companies, health care providers and terminally ill patients in a manner that well-represents Fred Hutch and its associated institutions (UW and SCCA).
- May assist in writing informed consent documents that clearly describe the nature and risks of the research project in language that is easily understandable to the individual patient.
- Follow institutional policies and procedures that ensure compliance with all aspects of Federal Drug Administration (FDA) and National Institutes of Health (NIH) regulations pertaining to clinical research in human subjects.
- Develop, document and maintain study-specific procedures for protocol registration and implementation to ensure that research execution meets good clinical practice guidelines.
- Design, create, revise, and complete research instruments (e.g. case report forms) as necessary to ensure quality data that correlates with research objectives.
- Ensure that projects are executed successfully and completed within needed time frames to meet research objectives.
- May process labs for clinical trials, including collecting, centrifuging and aliquoting specimens, and ship specimens in accordance with federal and institutional biologics shipping regulations.
- Ensure protocol compliance by managing patient appointments and coordinating with patient's clinical providers (e.g. physicians, physician assistants, and nurses) to collect reliable and accurate data.
- Understand clinical trial budget and billing plan for patients enrolled on clinical trials. Work with internal partners to ensure clinical trials are performed in accordance with institutional requirements for billing compliance. Assist in financial audits as necessary. Communicate with investigators and research staff when financial milestones have been met.
- Ensure patient safety while participating in clinical trials by monitoring patients and interacting closely with patients' clinical providers.
- Initiate and maintain communication with outside physicians who refer patients to SCCA and/or UWMC for oncology clinical trials.
- Prepare interim reports for the research program and sponsors to ensure that each project is moving toward timely completion.
- Assist investigators and research teams with the start-up and implementation of clinical studies, including obtaining and submitting budget/billing information, implementing the IRB-approved recruitment plan, interacting with research participants, scheduling study visits, gathering data, processing specimens, presenting information to research team, etc.
- Design, create, and revise research instruments as necessary to ensure quality data that correlates with research objectives; coordinate multiple protocol-specific data collection efforts for one or more research projects which may include other collaborating agencies or institutions.
- Consult with investigators on appropriate management of participant problems and concerns; troubleshoot acute individual or departmental research issues.
- Oversee regulatory, budgetary, contractual, and all other aspects of protocol implementation, ensuring compliance with applicable federal regulations, institutional policies, and the principles of Good Clinical Practice (GCP).
- BA/BS in a life sciences field required.
- A minimum of 2 years of experience in clinical research study coordination, preferably in oncology.
- Sound knowledge of FDA, GCP, and NIH requirements relating to research involving human subjects, including adverse event reporting and conducting projects in clinical facilities. Possesses the ability to integrate clinical providers in research processes. Experience using electronic data capture software.
- Strong computer skills and competency with Microsoft Office software.
- Strong attention to detail and ability to multi-task, organize and prioritize multiple projects.
- Experience in clinical trial processes, implementation of research protocols.
- Excellent written and verbal communication skills.
- Demonstrated ability to work independently, under supervision, and be a team player.
- Should be highly motivated and flexible, with the ability to adjust to rapidly changing priorities and new projects.
- Experience as a research coordinator for both investigator-initiated human subjects research projects and industry-sponsored clinical trials
- Ability to adapt and respond appropriately to competing priorities in a fast-paced environment.
We are a VEVRRA Federal Contractor.
If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=2232145-2647-4521