Qualifications

Must have a flexible schedule to work 10-15 hours per week.

Bachelors degree or equivalent work experience required

2-4 years experience in clinical research preferred

2-4 years non-profit, research, or healthcare experience desired

Demonstrate competence in oral and written communication

Must be organized, attentive to detail, and possess a positive, friendly and professional demeanor

Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner

Computer skills including at least intermediate level experience with Excel and other Microsoft Office Software

Knowledge of CFR, GCP and ICH guidelines

Key Responsibilities

Support Regulatory and Compliance Oversight: Coordinate local eIRB submissions, continuing reviews, and reportable events; ensure compliance with 45 CFR 46, DoD Human Research Protection Program (HRPP) requirements

Participant Recruitment and Study Conduct: Facilitate participant screening, informed consent, randomization, and follow-up visits at WRNMMC for up to approximately 20 participants in accordance with the approved protocol and IRB-approved consent documents

Data Collection and Management: Collect and record study data in accordance with the approved protocol, Institutional Review Board (IRB) determinations, and the informed consent form (ICF). Geneva will maintain site-level data in a secure, access-controlled database (e.g. REDCap) consistent with DoD and HIPAA requirements

Data Sharing and Coordination: Geneva will share de-identified data with the Prime Recipient as permitted under the protocol, IRB, and a separate Data Sharing Agreement to be executed between Geneva and WRNMMC.

Reporting and Communication: Provide periodic progress updates, regulatory documentation, and final close-out materials to the Prime in accordance with the terms of this Agreement

Other Responsibilities

Promote safety and confidentiality of research participants at all times

Adhere to Occupational Safety and Health Administration (OSHA), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and infection control procedures

Plan and coordinate the initiation of research study protocol, and the implementation of operating policies and procedures

Plan, implement and maintain data collection and analysis systems in support of research protocol; may coordinate the collection and analysis of research data

Recruit, instruct and coordinate research subjects and/or volunteers, as appropriate to specific study objectives and work scope

Coordinate the day-to-day activities of technical support staff specifically engaged in the carrying out of research/clinical protocol, as appropriate to the position; may perform aspects of research protocol, as required, in accordance with specified program objectives

• Organize and facilitate meetings, conferences, and other events associated with research activities; may perform and/or coordinate outreach activities, as appropriate to research objectives Document all correspondence and communication pertinent to the research Interact and communicate effectively with Principal Investigator, other site personnel, research participants, The Geneva Foundation, and the funding organization