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Site Manager
2 months ago
Site Manager
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
- All relevant Protocol Amendments Training
- Any study-specific Manuals Training as applicable
- 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 expectations
- Coaching, counseling, and disciplining the employees as applicable.
- To develop, coordinate, and enforce site-specific systems, policies, procedures, and productivity standards.
- Communicating and effective implementation of strategic goals from senior management to the site team.
- Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).
- Strive to ensure weekly, monthly, and quarterly assigned goals are met for their respective site(s).
- Being prepared for and available at all required company meetings.
- Submitting required administrative paperwork per company timelines.
- Occasionally attending out-of-town Investigator Meetings.
- Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives
- Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent
- Facilitate effective communication between patients, healthcare providers, and research staff
- Any 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.
- Speaking and Writing to communicate effectively as appropriate for the needs of the audience.
- Ability to multitask, adhere to deadlines, and work both independently and cooperatively with interdisciplinary teams.
- Strong computer skills in relevant software and related clinical systems are required.
- Comprehensive knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs.
- Proficient communication and comprehension skills both verbal and written in the English language are required.
- Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.
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