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Medix™ · 1 week ago

Clinical Research Site Manager - 248674

Nashville, TN

Full-time

Onsite

Senior Level

7+ years exp

Medix™ is a company focused on clinical research, and they are seeking a Clinical Research Site Manager to oversee the coordination and implementation of clinical trials. The role includes managing regulatory compliance, leading clinical operations, and ensuring the successful execution of studies while fostering a culture of accountability and continuous learning.

CrowdsourcingRecruitingSocial NetworkStaffing AgencyVenture Capital

Responsibilities

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

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

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

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)

Qualification

Clinical trial managementClinical Practices (GCP)International Conference on Harmonization (ICH)Regulatory complianceStaff managementIndependenceComputer skillsCommunication skillsProblem solvingAdaptability

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

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

Able to collect, organize, interpret, and record detailed information as required by study sponsors and regulatory and review agencies

Able to communicate with direct reports, co-workers, sponsors, and others in a collaborative and courteous manner

Knowledgeable in clinical operations and project management

Able to manage a staff of clinical professionals and create a productive, satisfying work environment

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

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

Able to use standard office software, as well as proprietary applications unique to the clinical research industry and individual sponsoring organizations