Clinical Research Site Manager - 248674 - Nashville - Medix™

Description

Job Title: Site Manager

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Job Description:

Contributor to the profitable management of the clinical research business, consistent with company principles, strategies, and objectives. Accountable for the overall coordination, organization, and efficient implementation of clinical trials including management of regulatory, clinical operations, and line management of Project Managers and support roles. Performs diverse managerial responsibilities requiring considerable analysis, judgment, and detailed understanding of clinical research processes.

Works closely with the Principal Investigator and Managing Partner to evaluate clinical trials and ensure that all study-related procedures are completed properly from a clinical and a regulatory perspective. In executing these position responsibilities, the Site Director is guided by Good Clinical Practices (GCP), International Committee on Harmonization (ICH) guidelines, and company standard operating procedures and policies.

Key Activities:

Planning and Management: Supports Managing Partner implementation of business plans for achieving the strategic and tactical goals and objectives of the line of business.

• Contributor to the business plan in collaboration with the PI and Managing Partner
• Contributor to the financial performance of the line of business.
• Enforce standardized policies, procedures, and performance metrics to ensure consistency and excellence in research operations, data management, and regulatory submissions and activities.
• Foster a culture of accountability, collaboration, and continuous learning.

Study Operations: Manages all aspects of clinical research studies and related office operations.

• Interviews, supports hiring process trains, , and manages Clinical Research Coordinators, Assistant Clinical Research Coordinators, Data Entry Specialists, Psychometric Raters, and the Front Desk Office Coordinators and Specialists.
• Evaluate staff performance, identify growth opportunities, and ensure role clarity.
• Oversees day-to-day clinical research operations, including protocol implementation, data management, and regulatory submissions and oversight.
• Manages the processes of informed consent, subject visits, source document, Case Report Form and other document preparation and disposition.
• Completes study visits and pre-screening visits of participants as business needs dictate.
• Partner with PI, Managing Partner, and research staff to ensure successful execution of clinical trials and adherence to timelines and budgets.
• Proactively identify operational risks and implement mitigation strategies to safeguard research quality, compliance, and patient safety.
• Maintain readiness for sponsor and regulatory inspections, serving as subject matter expert on compliance and quality matters.
• Serve as Point of Contact for internal and external audits, monitor compliance trends, and implement corrective and preventative actions to uphold operational integrity.

Subject Recruitment: Assists Managing Partner with the implementation of plans for recruiting subjects into each study.

• Includes coordination and oversight of site metrics
• Includes collaboration with recruitment department as designated by Managing Partner

Regulatory Oversight: Oversees regulatory activities for all studies including timelines, personnel

involved, and key activities. Responsible for delivery of regulatory activities and site level metrics. Ensures that studies are implemented in compliance with Good Clinical Practice (GCP) guidelines as promulgated by the Food and Drug Administration (FDA) and the International Conference on Harmonization (ICH).

Skills Required:

• B.A. or B.S. required;. A minimum of 7 years of progressive clinical trial management experience is required including prior Clinical Research Coordinator experience and experience in line management and/or leading teams
• Excellent communication, interpersonal, and problem solving skills with proven track record of implementing quality improvement initiatives, training programs, and regulatory compliance strategies in clinical research settings.
• Understanding of Clinical Research Requirements:Demonstrated knowledge with clinical research study processes and requirements. Understands regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines.
• Thoroughness and Accuracy: Able to collect, organize, interpret, and record detailed information as required by study sponsors and regulatory and review agencies.
• Communication: Able to communicate with direct reports, co-workers, sponsors, and others in a collaborative and courteous manner. Knowledgeable in clinical operations and project management.
• Management: Able to manage a staff of clinical professionals and create a productive, satisfying work environment.
• Independence: Demonstrates the initiative to act independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, this job description, and company policy.
• Adaptability: Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change. xhmxlyz
• Computer Skills: Able to use standard office software, as well as proprietary applications unique to the clinical research industry and individual sponsoring organizations.