Clinical Research Site Supervisor

2 weeks ago


Philadelphia, Pennsylvania, United States Barrington James Full time

Position Title: Clinical Research Site Supervisor

Overview: The Clinical Research Site Supervisor is responsible for ensuring the integrity and quality of clinical trials at designated research locations. This role involves strict adherence to sponsor protocols, regulatory standards, and industry guidelines, with a focus on achieving enrollment targets and meeting organizational objectives efficiently.

Core Responsibilities:

  • Complete essential training programs (including ICH-GCP and IATA) in a timely manner.
  • Maintain current knowledge of FDA regulations, ICH-GCP standards, and specific study protocols.
  • Oversee site personnel under the direction of the Site Director.
  • Ensure all necessary training is finalized prior to the initiation of a study.
  • Prepare for visits from sponsors and CROs, addressing any follow-up actions required.
  • Utilize and apply up-to-date study documentation and protocols effectively.
  • Manage clinical trial processes from initiation to completion, ensuring compliance with all applicable regulations and guidelines.
  • Ensure high standards of data quality, participant retention, and regulatory compliance.
  • Lead and mentor site staff, establishing clear expectations and enforcing site policies.
  • Communicate strategic objectives to the site team clearly.
  • Achieve enrollment and performance benchmarks for the site.
  • Participate in mandatory company meetings and ensure timely submission of required documentation.
  • Occasionally represent the site at Investigator Meetings held in various locations.
  • Conduct discussions with patients regarding consent, ensuring they understand the procedures, risks, and benefits involved.
  • Facilitate effective communication among patients, healthcare professionals, and research staff.
  • Perform additional responsibilities as assigned by management.

Qualifications:

  • Education: A Bachelor's degree is preferred; an advanced degree is advantageous.
  • Experience: A minimum of 4 years in clinical research, including at least 2 years in a supervisory capacity.
  • Credentials: CCRC or equivalent certification is preferred.
  • Skills: Strong abilities in teamwork, organization, problem-solving, critical thinking, multitasking, and communication. Proficiency in relevant software, FDA regulations, and ICH-GCP is essential. Bilingual proficiency in English and Spanish is preferred.


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