Clinical Site Manager

1 month ago


Philadelphia, United States Barrington James Full time

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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