Research Program Supervisor
The Department of Oncology is seeking a Research Program Supervisor that will work under the direct supervision of the Sr. Clinical Research Program Manager. This role is responsible for data management, regulatory activities, and research activities of patients entered onto clinical trial protocols for the Genitourinary (GU) Oncology Clinical Research Program and participating sites. The Research Program Supervisor is responsible for the organization, submission, maintenance and accuracy of all patient clinical research data and regulatory compliance; assist with multicenter study site activation and management, including regulatory review, data monitoring, and integrity management; assist the Program Manager with general operations of the program. The Research Program Supervisor also has supervisory responsibilities of two or more Research Program Assistants and/or Research Program Coordinators in the GU Program.
DUTIES AND RESPONSIBILITIES
- Responsible for supervising two or more fulltime Research Program Assistants and/or Research Program Coordinators with hire, fire, discipline and coaching authority.
- Maintain detailed working knowledge of all assigned protocols and reporting requirements. Work on complex clinical trials that require a high level of knowledge, coordination, and organization. Transmit and distribute protocol information. Responsible for submission, verification, and maintenance of protocol specific information on the SKCCC Research Protocol Library.
- Maintain electronic regulatory records for each assigned protocol. Prepare and submit annual renewal requests, amendments, and adverse event reports with clinical input according to IRB and Sponsor requirements. Adhere to all protocol requirements to ensure the validity of the clinical research data. Coordinate patient enrollment, verify patient eligibility, data abstraction, case report form completion and submission, administration of quality of life questionnaires, query resolution and responses, specimen shipping, and other protocol-related tasks.
- Maintain an electronic research chart for each patient and research patient registration data in SKCCC databases. Ensure accuracy and timeliness of data so that information may be used by the physician in treatment planning, presentations, and publication.
- Assist with protocol development and revision of investigator-initiated studies: Assure protocols, amendments, consent forms, and study operation manuals have complete, consistent language throughout, including proper SAE reporting requirements, coordinating center requirements, etc.
- Assist the conduct of investigator-initiated multicenter clinical trial protocols, including study site selection and activation, electronic case report form design, site study staff training, specimen shipping, data monitoring, safety review, and other protocol-related tasks.
- Communicate regularly with principal investigators, research nurses and the Program Manager to review data accuracy and overall study progress.
- Attain a high level of expertise in institutional databases including EPIC, CRMS, and eIRB. Complete minimum requirements for continuing education units. Maintain up-to-date knowledge of and comply with Good Clinical Practice, ICH Guidelines, and SKCCC Clinical Research Office policies.
- Participate in all mandatory meetings to develop increasing knowledge of clinical trials operations. Participate as requested in Cancer Center initiatives such as training and orientation of new staff, best practices work groups, and development of Standard Operating Procedures.
Bachelor’s Degree related discipline and two years relevant experience required. Additional education may substitute for required experience and additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.
Some supervisory experience and experience with Oncology and eIRB is desirable.
JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.
Salary: $38,443 - $52,870
Department name: 10002941-SOM Onc Urologic Oncology
Work Schedule/Hours: M-F, 8:30 am - 5:00 pm
Location: 04-MD:School of Medicine Campus
Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.
During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.
The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
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