
Clinical Research Director
2 days ago
Job Title: Senior Clinical Research Manager
Job Summary:This is a highly responsible position that will lead and manage clinical trials and research studies, ensuring they are completed on time and in compliance with regulatory standards.
Key Responsibilities:
- Develop, implement, and manage clinical research projects from start to finish.
- Coordinate and oversee the execution of clinical trials, ensuring adherence to protocols, timelines, and budgets.
- Ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and ethical standards.
- Provide oversight on the recruitment, enrollment, and monitoring of clinical trial subjects.
- Manage relationships with investigators, external vendors, and other stakeholders.
Leads and mentors clinical research staff, ensuring they are trained and performing effectively.
Assigns tasks and responsibilities to team members based on project needs.
Develops training programs and provides ongoing professional development for research teams.
Regulatory Compliance:Oversees the preparation and submission of regulatory documentation, including Institutional Review Board (IRB) applications and clinical trial applications.
Monitors compliance with federal, state, and local regulations, as well as company policies.
Ensures timely reporting of adverse events and ensures the study meets ethical and regulatory standards.
Study Design & Protocol Development:Works with scientific and medical teams to develop clinical trial protocols.
Evaluates feasibility and risk of proposed studies.
Ensures protocols meet study objectives, regulatory standards, and ethical guidelines.
Communication and Collaboration:Fosters communication between internal teams, external partners, and key stakeholders.
Collaborates with clinical research coordinators, data managers, and other departments to ensure effective study execution.
Resolves any issues related to clinical trial execution and provides solutions.
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