We are seeking a Research Program Coordinator to work under the direct supervision of the Sr. Clinical Research Program Manager and the Principal Investigator(s), the Research Program Coordinator is responsible for monitoring the clinical course and collection of research data on patients entered onto research protocols in the Developmental Therapeutics Program. The Research Program Coordinator is responsible for the organization, entry, maintenance and accuracy of all patient clinical research data in a timely and ongoing manner. This is an introductory level position in managing clinical trials and/or registry databases.
Specific Duties & Responsibilities
Data Management
- Manages and coordinates patients on trials which can include ordering, scheduling, patient interactions/assessments, and data input. Utilizing the study calendar, tracks patient progress and upcoming visits for accuracy. May design and compile materials which aid physicians/other staff in complying with protocol requirements for these visits and tests.
- May assist with consenting study participants and documenting the consent process. Documents telephone and other communications with patients per institutional policy.
- 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.
- When necessary, requests pertinent patient records and tissue samples as required.
- Maintains a 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 for individual patients, presentations and publication.
- Prepares reports on individual patients or the study as required by the principal investigators and/or external agencies. Responds in a timely manner to special projects or queries related to the data.
- Maintains a protocol database or spreadsheet for tracking patient activity and data submission to internal and/or external registries. Makes timely patient status updates and visit check-ins in OnCore.
Regulatory Management
- Maintains good working knowledge of all assigned protocols and reporting requirements. Adheres to all protocol requirements to ensure the validity of the clinical research data.
- Disseminates protocol information and updates to other study team members, as necessary.
- Prepares and submits annual renewal requests, amendments and adverse event reports with clinical input according to IRB and Sponsor requirements.
- Responsible for submission, verification, and maintenance of protocol specific information on the SKCCC Research Protocol Library and OnCore.
- Maintains regulatory binder for each assigned protocol.
- Prepares for and participates in monitoring and audits of studies. Corrects errors in database when necessary.
- Meets regularly with members of the study team to review data accuracy and overall study progress. Participates in all mandatory meetings to develop increasing knowledge of assigned clinical trial and Registry requirements.
- May assist the principal investigator and/or program manager in defining information and plans required to accomplish goals of studies. May help design and create protocol specific data collection forms with assistance.
- Completes minimum requirement for continuing educational units. Has working knowledge of and complies with Good Clinical Practices, ICH Guidelines and SKCCC Clinical Research Office policies.
Minimum Qualifications
- Bachelor’s Degree in related discipline.
- Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.
Preferred Qualifications
- Experience working with patients and/or in a clinical setting preferred.
Classified Title: Research Program Coordinator
Role/Level/Range: ACRO40/E/03/CD
Starting Salary Range: $17.00 - $30.00 HRLY ($23.46/hour targeted; Commensurate with experience)
Employee group: Full Time
Schedule: M-F, 830-500
Exempt Status: Non-Exempt
Location: Hybrid/School of Medicine Campus
Department name: SOM Onc Developmental Therapeutics
Personnel area: School of Medicine
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