Site Manager - DM Clinical Research

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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