Position Summary

Odyssey Systems is pursuing a new opportunity for a Program Manager (Human Studies) who will support the Travis Air Force Base (AFB) David Grant Medical Center/Clinical Investigation Facility (CIF). Their mission is assisting with the execution of DoD medical research requirements accomplished through the performance of clinical studies and programs. This position is located at Travis AFB in Fairfield, CA. ***Contingent upon contract award*** 

Responsibilities

Duties include, but not limited to: 

• Assist in providing oversight of all aspects of all 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

Minimum Required Qualifications:

Citizenship: Must be a US citizen

Clearance: NACI (ability to obtain)

Education: BS/BA/MS in Biomedical Science or related field

Years’ experience: 6 years’ experience in program and project management

Preferred: MBA/Ph.D. in Biomedical Science ; 8 years' experience 

Skills: 

• Conducts biomedical, translational, clinical, and military research; Manages human research projects; Assists GME activities 
• Ideal to have good project management skills/knowledge and will collaborate with different PIs and residents and manage the human research portfolio as assigned. 

Additional Information:

Location: Travis AFB

Travel: 10%

Remote, Onsite, or Hybrid: Onsite

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Company Overview

Odyssey Systems Consulting Group, is an innovative small business committed to providing world-class technical, management, and training support services to government and public sector clients. We focus on people, processes, and performance to deliver superior results. Since our inception in 1997, our commitment to mission success and customer satisfaction has been recognized with exponential growth and exceptional past performance ratings. We accept challenging assignments and drive projects from the planning stages, through implementation, and into operations and support.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Please Note:

Final compensation for this position will be determined by various factors such as the Federal Government contract labor categories and contract wage rates, relevant work experience, specific skills and competencies, geographic location, education, and certifications.Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, Tricare supplement, short-term disability, long-term disability, 401(k) match, flexible spending accounts, health savings accounts, employee assistance program, learning and development benefit, paid time off, and holidays.Odyssey Benefits