The Research Program Manager’s responsibilities include the implementation, conduct, and day-to-day oversight of multiple, complex research protocols for devices, biomedical, and behavioral studies. Additionally, the Research Program Manager oversees the design and implementation of public health interventions. The Research Program Manager is responsible for oversight of all aspects of the research projects including regulatory submissions, research participant screening, eligibility assessment, oversight multiple studies, data analysis, and contributing to the preparation of research reports.
Essential Duties and Responsibilities Includes the Following.
Other duties may be assigned.
The Research Program Manager is expected to contribute to ongoing public health research projects through the Public Health Division, which include but are not limited to:
- Managing multiple studies and manage the administrative and scientific implementation of research protocol for multiple complex research studies. This position will have a great degree of independence from the principal investigator.
- As part of study team, collaborate with faculty, develop protocols, develop standard operating procedures (SOPs), ensure SOPs are observed, interact with human subjects, and supervise study-related activities for one or more studies.
- Supervise staff at the local site and interact with staff at other collaborative sites.
- Entirely supervise other research staff and be responsible for assistance with grant submissions, research reports, and preparation and execution of regulatory compliance documents.
- Responsible for the implementation, coordination, and management of the study protocol in collaboration with the principal investigator, co-investigators, and research assistants.
- Maintain regulatory compliance per FDA, NIH, CDC, DHHS, Good Clinical Practice.
- Develop and maintain an accurate, current, and secure computer database of study participants and data.
- Develop and modify case report forms as needed. Develop and oversee maintenance of paper-based study participant files. Develop, track, and maintain storage of frozen serum specimens in computer databases and within physical storage facilities. Develop, implement, and monitor study participant recruitment objectives and strategies.
- Monitor patient accrual, follow up, data collection and perform quality assurance checks on data. Schedule patients for laboratory tests, medical examinations, and consultations. Maintain accurate information on each patient to facilitate patient encounters. Telephone and interview participants and/or family members to obtain accurate pre-registration information and to confirm appointments. Coordinate laboratory specimen processing, storage, and shipment using approved bio-safety techniques. Communicate with clinical and study staff to promote and ensure successful recruitment for studies and medical management while in the study. Communicate with the principal investigator, co-investigators, and collaborators regarding the progress of the research and management of problems. Disseminate information to research participants.
- Administrative duties include but not limited to: Scheduling of research-related appointments, medical examinations, and laboratory appointments; relaying information to research volunteers regarding preparation for tests and examinations; maintaining research calendar; scheduling research appointments and meeting rooms; opening, sorting and screening research-related mail; use of automated systems, such as database and production software, to access, enter, and edit patient information.
- Reports to the Director of Advocacy and Policy Research weekly.
- Other duties and responsibilities may be assigned.
Supervision of designated Research Associates. Supervision of “non-employees” including contractors, volunteers, interns, and vendors of service.