UNIV - Research Program Coordinator II - Regulatory Coordinator - Department of Neurology

Job Description Summary

The Regulatory Coordinator serves as the departmental regulatory expert supporting the development, activation, and ongoing compliance of clinical research studies within the Department of Neurology. Working independently under general supervision of Principal Investigators and departmental research leadership, this position coordinates regulatory activities for investigator-initiated, industry-sponsored, foundation-funded, federally funded, cooperative group, registry, observational, interventional, translational, and other human subjects research studies.

The Regulatory Coordinator manages study start-up submissions and approvals, facilitates communication with the Institutional Review Board (IRB) and other oversight committees, maintains regulatory compliance throughout the research lifecycle, and serves as a departmental resource to research personnel regarding regulatory requirements, policies, and best practices.

This position supports compliance with institutional, state, federal, sponsor, FDA, OHRP, HIPAA, and ICH-GCP requirements to help ensure protection of research participants and successful execution of the department's clinical research portfolio.

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type​

Research Grant

Cost Center

CC000985 COM Neurology CC

Pay Rate Type

Salary

Pay Grade

• University-GEN09
• Pay Range

53,142.00 - 71,706.00 - 90,372.000

Scheduled Weekly Hours

40

Work Shift

Job Description

Regulatory Coordinator - Clinical Research

The Regulatory Coordinator serves as the departmental regulatory expert supporting the development, activation, and ongoing compliance of clinical research studies within the Department of Neurology. Working independently under general supervision of Principal Investigators and departmental research leadership, this position coordinates regulatory activities for investigator-initiated, industry-sponsored, foundation-funded, federally funded, cooperative group, registry, observational, interventional, translational, and other human subjects research studies.

The Regulatory Coordinator manages study start-up submissions and approvals, facilitates communication with the Institutional Review Board (IRB) and other oversight committees, maintains regulatory compliance throughout the research lifecycle, and serves as a departmental resource to research personnel regarding regulatory requirements, policies, and best practices.

This position supports compliance with institutional, state, federal, sponsor, FDA, OHRP, HIPAA, and ICH-GCP requirements to help ensure protection of research participants and successful execution of the department's clinical research portfolio.

Essential Duties and Responsibilities

1. Regulatory Study Start-Up and IRB Submissions

35%

• •Independently coordinate regulatory start-up activities for new research studies, including investigator-initiated, industry-sponsored, foundation-funded, NIH/federal, observational, interventional, registry, and translational research projects.
• •Prepare, review, and submit applications to the Institutional Review Board (IRB), ancillary review committees, and other applicable institutional or external oversight bodies.
• •Collaborate with Principal Investigators, study teams, sponsors, contract and budget offices, and institutional research offices to facilitate timely study activation.
• •Review protocols, informed consent documents, recruitment materials, investigator brochures, data collection tools, grant-related study documents, and supporting regulatory materials for completeness and compliance.
• •Coordinate responses to IRB contingencies, stipulations, and requests for modification.
• •Monitor study activation timelines and proactively identify barriers to regulatory approval.

2. Ongoing Regulatory Compliance and Study Maintenance

35%

• •Manage regulatory submissions throughout the lifecycle of active studies, including amendments, continuing reviews, reportable events, protocol deviations, safety reports, administrative updates, and study closures.
• •Maintain regulatory binders and electronic regulatory files in accordance with institutional, sponsor, FDA, OHRP, HIPAA, and ICH-GCP requirements.
• •Conduct routine reviews of study documentation to support ongoing regulatory compliance.
• •Monitor approval expiration dates, continuing review deadlines, consent versioning, training documentation, and other regulatory milestones to prevent study lapses or noncompliance.
• •Assist research teams in preparing for sponsor monitoring visits, internal reviews, audits, inspections, and compliance inquiries.
• •Identify regulatory risks and recommend corrective and preventive actions when needed, escalating concerns appropriately.

3. Research Regulatory Consultation, Training, and Departmental Support

15%

• •Serve as a departmental subject matter resource regarding human subjects research regulations, IRB requirements, and institutional research policies.
• •Provide guidance to investigators, clinical research coordinators, program managers, and research staff on regulatory processes, study documentation, informed consent requirements, and compliance expectations.
• •Develop and maintain departmental regulatory tools, templates, guidance documents, checklists, workflows, and standard operating procedures.
• •Educate study teams regarding changes in federal regulations, sponsor requirements, and institutional policies affecting research compliance.
• •Participate in department meetings, research operations discussions, and study planning activities to promote regulatory best practices.

4. Quality Improvement, Reporting, and Regulatory Program Development

15%

• •Assist with development and implementation of regulatory quality improvement initiatives across the department's research portfolio.
• •Perform regulatory quality assurance reviews and identify opportunities to improve study start-up, submission accuracy, documentation practices, and compliance workflows.
• •Generate reports and metrics related to study activation, IRB submissions, regulatory timelines, compliance status, audit findings, and departmental research performance.
• •Contribute to development, revision, and implementation of departmental policies, procedures, and regulatory workflows.
• •Participate in special projects and other research administration activities as assigned.

MUSC Minimum Training and Experience Requirements:

A bachelor's degree and three years of relevant program experience.

Preferred Minimum Training and Experience:

• •Bachelor's degree in health sciences, biological sciences, public health, nursing, clinical research, research administration, or a related field.
• •Three (3) years of clinical research, regulatory affairs, research administration, IRB, or research compliance experience.
• •Demonstrated knowledge of human subjects research regulations, FDA regulations (21 CFR), OHRP requirements (45 CFR 46), HIPAA, ICH-GCP guidelines, and clinical trial regulatory processes.
• •Experience preparing, reviewing, and submitting IRB applications, amendments, continuing reviews, and related regulatory documentation.
• •Excellent organizational, analytical, written communication, project management, and customer-service skills.
• •Ability to manage competing priorities, meet deadlines, exercise sound judgment, and work independently while appropriately escalating complex regulatory issues.

Preferred Qualifications:

• •Five (5) or more years of regulatory, IRB, or clinical research experience.
• •Experience supporting NIH/federally funded, foundation-funded, investigator-initiated, cooperative group, and industry-sponsored clinical research.
• •Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), ACRP, or equivalent research certification.
• •Experience with electronic IRB systems, clinical trial management systems, electronic regulatory binders, and ele