Clinical Research Site Manager

Job description

The Site Manager's job is to ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. Also To ensure study enrollment meets or exceeds Sponsors' expectations and company goals are achieved on a timely basis.

DUTIES & RESPONSIBILITIES:

• Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis
• Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s)
• Responsible for immediate supervision and performance of the assigned site staff under the supervision of the Site Director or Director of Site Operations
• Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to
• Sponsor-provided and IRB-approved Protocol Training
• Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training
• It is the responsibility of the Site Manager to make sure all the relevant training is completed prior to performing any applicable tasks on the assigned study
• Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate as well as timely follow-up on the action items, at their respective sites
• Make sure that the most recent versions of the Protocol, Informed Consents, Study Manuals and all the other relevant study-related documents are utilized and implemented at all times for the assigned protocol(s) at their respective site(s)
• Ensuring clinical trial management from FPFV to study close out with strict adherence to study protocol, adherence to all other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C standards, organizational SOPs, and guidance documents
• Ensuring data quality, subject retention, and compliance, timely and adequate study data reporting on the assigned protocol(s) being conducted at their respective site(s)
• Accomplishing site objectives by managing staff; facilitating staff training as applicable; communicating job expectation
• sFacilitate effective communication between patients, healthcare providers, and research staf
• fAny other matters as assigned by management

KNOWLEDGE & EXPERIENCE:

Education:

• Bachelor’s degree preferred
• Advanced degree preferred

Experience:

• At least 4 years of clinical research coordinator experience, including 2 years of management experience at a clinical research organization

Credentials

• Certified Clinical Research Coordinator (CCRC) or equivalent certification preferred

Knowledge and Skills

• Solid teamwork, organizational, interpersonal, and problem-solving skills and attention to detail
• Critical Thinking
• Active Listening
• Reading Comprehension — Understanding written sentences and paragraphs in work-related documents

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