Clinical Site Manager
1 month ago
Job Title: Site Manager
Overview: The Site Manager ensures high-quality research at assigned sites, adhering to sponsor protocols, FDA regulations, and ICH/GCP guidelines. They aim to meet or exceed enrollment targets and achieve company goals on time.
Key Responsibilities:
- Complete mandatory training (ICH-GCP, IATA) promptly.
- Stay updated on FDA regulations, ICH-GCP guidelines, and study protocols.
- Supervise site staff under the Site Director's guidance.
- Ensure all relevant training is completed before starting a study.
- Prepare for sponsor and CRO visits, and address follow-up action items.
- Use and implement current study documents and protocols.
- Manage clinical trials from start to finish, ensuring adherence to all regulations and guidelines.
- Maintain data quality, subject retention, and compliance.
- Manage and train staff, set expectations, and enforce site policies.
- Communicate strategic goals to the site team.
- Meet enrollment and site performance goals.
- Attend required company meetings and submit paperwork on time.
- Occasionally attend out-of-town Investigator Meetings.
- Conduct patient consent discussions, ensuring understanding of procedures, risks, and benefits.
- Facilitate communication between patients, healthcare providers, and research staff.
- Perform additional tasks as assigned by management.
Qualifications:
- Education: Bachelor's degree preferred; Advanced degree is a plus.
- Experience: Minimum 4 years in clinical research, with 2 years in a management role.
- Credentials: CCRC or equivalent certification preferred.
- Skills: Strong teamwork, organizational, problem-solving skills, critical thinking, multitasking, and communication skills. Proficient in relevant software, FDA regulations, and ICH-GCP. Bilingual (English/Spanish) preferred.
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