We are seeking a highly organized and detail-oriented Clinical Research Specialist to join a global clinical operations team supporting the execution and oversight of medical device studies. This is a remote, non-travel role ideal for professionals experienced in site management, data oversight, and study documentation, particularly in the post-market or late-phase setting.
Key Responsibilities:
- Serve as the primary point of contact for assigned clinical study sites, including hospitals and private practices.
- Manage all site-level activities throughout the study lifecycle: selection, preparation, activation, enrollment, maintenance, and closeout.
- Collaborate closely with cross-functional teams, including Clinical Study Managers, CRAs, Clinical Trial Associates, and regional vendors.
- Coordinate the collection and review of regulatory documents, informed consent forms, and ethics submissions.
- Ensure adherence to ICH-GCP, ISO 14155, and local regulatory standards.
- Monitor data quality and ensure timely documentation and resolution of issues.
- Support site readiness and training, subject visit scheduling, and follow-up activity.
- Track site performance, compliance metrics, and timelines using study management systems.
- Assist with vendor oversight, including qualification and performance tracking.
- Participate in internal study meetings and collaborate with local and global teams.
Required Qualifications:
- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related clinical/scientific field (Master’s preferred).
- Minimum of 2 years of relevant clinical research experience.
- Experience in medical device trials or post-market surveillance is highly preferred.
- Knowledge of Good Clinical Practice (GCP); GCP certification required.
- Proficiency in study management tools (e.g., CTMS) and regulatory documentation.
Additional Notes:
- No travel required.
- Candidates must reside in ET or CT time zones; flexibility in hours is available.
- Ideal for those with experience in in-house CRA roles or late-stage clinical operations.
Apply today to join a mission-driven team dedicated to advancing patient outcomes through high-quality clinical research.