Full Job Description
Clinical Study Specialist
In this role, you will provide technical and administrative support to clinical study teams executing trials across a program, helping ensure studies stay on track from site activation through close-out, while collaborating with Clinical Study Leads, Clinical Study Associate Managers, CROs, and study sites.
This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & where:
- Location: Armonk, NY, Warren, NJ
- Hybrid; 4 days per week onsite
Discover your role:
- 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
This role requires:
- 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
Salary Range (annually)
$93,900.00 - $153,300.00
