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

Medical University of South Carolina•Charleston, SC

1d•Onsite

About The Position

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.

Requirements

A bachelor's degree and two years of relevant program 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.
Ability to perform job functions in an upright position.
Ability to perform job functions in a seated position.
Ability to perform job functions while walking/mobile.
Ability to work indoors.
Ability to fully use both hands/arms.
Ability to perform repetitive motions with hands/wrists/elbows and shoulders.
Ability to reach in all directions.
Possess good finger dexterity.
Ability to maintain tactile sensory functions.
Ability to maintain 20/40 vision, corrected, in one eye or with both eyes.
Ability to see and recognize objects close at hand.
Ability to see and recognize objects at a distance.
Ability to determine distance/relationship between objects; depth perception.
Good peripheral vision capabilities.
Ability to maintain hearing acuity, with correction.
Ability to perform gross motor functions with frequent fine motor movements.

Nice To Haves

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.
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 electronic medical record systems.
Experience supporting multiple investigators, complex protocols, multiple funding mechanisms, and a large active clinical research portfolio.
Strong working knowledge of clinical research regulatory requirements and ethical principles for the protection of human subjects.
Ability to interpret and apply institutional policies, sponsor requirements, federal regulations, and IRB guidance to practical study operations.
Advanced attention to detail and ability to prepare accurate, complete, and timely regulatory submissions.
Strong interpersonal skills with the ability to advise faculty, coordinators, sponsors, and institutional offices in a professional and collaborative manner.
Ability to create and maintain organized regulatory records, templates, workflows, and compliance tracking tools.
Proficiency with Microsoft Office applications and ability to learn institutional research systems.
Ability to work in confined/cramped spaces.
Ability to perform job functions from kneeling positions.
Ability to squat and perform job functions.
Ability to perform 'pinching' operations.
Ability to lift and carry 15 lbs., unassisted.
Ability to lower objects, up to 15 lbs., from height of 36 inches to floor level, unassisted.
Ability to push/pull objects, up to 15 lbs., unassisted.
Ability to work outdoors in all weather and temperature extremes.

Responsibilities

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.
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.
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.
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.