Program Manager

Job Description: Assist in providing oversight of all aspects of all human studies. Organize and prioritize all activities associated with conducting phase I, II and III of these studies in a military setting. Review and understand biomedical research protocols, ensuring applicable regulations and guidelines are followed. Enter required data on paper or electronic case report forms (CRFs), audit records for accuracy, resolve discrepancies, and correct as necessary. Develop patient information and informed consent forms and patient recruitment materials. Administer appropriate forms and processes necessary to complete the research protocol. Advertise the study and assist with enrollment of research subjects. Complete the necessary documents for approval, including the informed consent recruitment materials, and data collection forms. Collect, organize and maintain all essential documents required for study regulatory. Meet with potential research subjects to explain the research project in detail and enroll eligible subjects into the study by obtaining written informed consent. Coordinate subjects study incentive payments. Schedule subjects for research appointments and external lab requirements. Maintain complete and accurate data on enrollees, data, costs and all relevant paperwork. Abstract required research data elements from paper or electronic patient records or other existing documents or files, in accordance with an approved research protocol and enter these data in the spreadsheets, databases, and/or statistics software. Work with the primary investigator and/or statistician to refine and prepare data sets for analysis. Coordinate statistical and scientific consultation from CIF staff. Identify delays and other shortcomings in meeting objectives and develop a contingency plan, as required. Maintain a master calendar for the study and serve as point of contact for research subjects. Coordinate the submission of research protocol amendments, progress reports, and final report to the study sponsor and the IRB. Immediately report any adverse events to the Medical Monitor or Data Safety Monitoring Board, sponsor and the IRB. Obtain and maintain NIH and CITI training in accordance with local IRB policy Qualifications: Education BS/BA/MS in Biomedical Science or related field MBA/Ph.D. preferred in Biomedical Science Experience Preferred 8+ years’ experience in program and project management Conducts biomedical, translational, clinical, and military research; Manages human research projects; Assists GME activities Knowledge Ideal to have good project management skills/knowledge and will collaborate with different PIs and residents and manage the human research portfolio as assigned. Job Type: On-Site Job Type: Full-time Pay: $80,534.00 - $125,856.00 per year Benefits: Health insurance Paid time off Schedule: Day shift Monday to Friday Weekends as needed Ability to commute/relocate: Fairfield, CA 94533: Reliably commute or planning to relocate before starting work (Required) Education: Master's (Preferred) Experience: program and project management: 8 years (Required) human research projects: 8 years (Required) biomedical, translational, clinical, and military research: 8 years (Preferred) Work Location: In person