Organizes and delivers analyzable reports and metrics, and coordinates study team meetings, agendas, and minutes
Collates data for feasibility and site selection assessments, and contributes to review of study documents (e.g., informed consent forms, case report forms) and reference materials (e.g., regulatory, pharmacy, laboratory binders)
Tracks site activation, enrollment, and monitoring visits against projected plans, escalating issues or delays, and monitors investigator/site status and registry postings
Ensures timely receipt of scheduled reports (e.g., 1572s, financial disclosures) and performs TMF reconciliations with study lead guidance
Communicates with sites as directed, maintaining site contact information and strong relationships internally and externally
Contributes to close-out activities (e.g., 1572s, IP reconciliation, financial disclosures, CRA close-out visits) and supports oversight of third-party vendors as needed
Brings attention to detail, resourcefulness, and proactive problem-solving to assigned study activities, investigating impact on trials as new information arises
Participates in SOP revisions and departmental initiatives, proactively recommending process improvements

Bachelor's degree with 2+ years of industry-related work experience in a clinical setting
Ability to acquire working knowledge in trial management systems and MS applications (Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF)
Basic familiarity with medical terms and clinical drug development
Awareness of ICH/GCP
Proactive, self-disciplined, and effective at managing deadlines and priorities

Clinical Study Specialist

Key skills