Research Program Coordinator
Under the direct supervision of the Sr. Clinical Research Program Manager or the Sr. Research Program Supervisor, we are seeking a Research Program Coordinator (RPC) who will be responsible for monitoring the clinical course and collection of research data on patients entered onto research protocols at the Sidney Kimmel Comprehensive Cancer Center and participating sites. The RPC is responsible for the organization, entry, maintenance and accuracy of all patient clinical research data in a timely and ongoing manner. This is an intermediate level position in managing clinical trials and/or registry databases within the Upper Aerodigestive (UAD) Oncology Clinical Research Program.
Specific Duties & Responsibilities
- Maintains good working knowledge of all assigned protocols and reporting requirements.
- Transmits and distributes protocol information.
- Responsible for submission, verification, and maintenance of protocol specific information on the SKCCC Research Protocol Library.
- Maintains electronic and/or physical regulatory binder for each assigned protocol.
- Prepares and submits annual renewal requests, amendments, and adverse event reports with clinical input according to IRB and Sponsor requirements.
- Adheres to all protocol requirements to ensure the validity of the clinical research data.
- May assist the principal investigator and/or program manager in defining information and plans required to accomplish goals of studies.
- Will design and create protocol specific case report forms as needed.
- Verifies patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements.
- Confirms patient registrations and relevant data points in databases for the SKCCC Clinical Research Office and Oncology Information Systems.
- Maintains an electronic or physical research chart for each patient.
- Collects, enters and compiles clinical data from a variety of sources.
- Ensures accuracy and timeliness of data so that information may be used by the physician in treatment planning, presentations, and publication.
- Verifies scheduling of patient appointments, tests, and follow up visits at the appropriate time in the treatment cycle to ensure completion of protocol requirements.
- May design and compile materials which aid physicians/other staff in complying with protocol requirements for these visits and tests.
- Meets regularly with Principal Investigator, Research Nurse, and Research Program Manager to review data accuracy and overall study progress.
- Participates in all mandatory meetings to develop increasing knowledge of assigned clinical trial and registry requirements.
- Prepares for and participates in monitoring and audits of studies.
- Corrects errors in database when necessary.
- Writes responses to audit reports with input from the Principal Investigator.
- Completes minimum requirement for continuing educational units.
- Is knowledgeable of and complies with Good Clinical Practices, ICH Guidelines and SKCCC Clinical Research Office policies.
- May instruct introductory level clinical research personnel in these guidelines and policies.
- Assists with study budget and invoice preparation as needed.
Minimum Qualifications
- Bachelor's Degree in related discipline.
- Additional education may substitute for required experience and additional related experience may substitute for required education beyond HS Diploma/Graduation Equivalent, to the extent permitted by the JHU equivalency formula.
Classified Title: Research Program Coordinator
Job Posting Title (Working Title): Research Program Coordinator
Role/Level/Range: ACRO40/E/03/CD
Starting Salary Range: $17.20 - $30.30 HRLY ($24.04/hour targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: Mon - Fri / 8am - 4:30p
FLSA Status: Non-Exempt
Location: Hybrid: On-site 3-4 days a week
Department name: 10002938-SOM Onc Upper Aerodigestive Cancer
Personnel area: School of Medicine