Clinical Research Compliance Lead

Meharry Medical College; United States; On-site; USD 90,000 - 120,000; Full time

Job summary

Meharry Medical College seeks a Regulatory Compliance Manager to support the Executive Director in planning, coordinating regulatory activities for clinical research projects. The role focuses on regulatory submissions, documentation, and ensuring adherence to ICH-GCP, FDA, IRB, and Common Rule guidelines.

Responsibilities include preparing submissions for INDs/IDEs, maintaining regulatory binders, reviewing documents, and serving as a regulatory contact for sponsors and authorities.

Qualifications

• Effective oral and written communication skills in English.
• Excellent interpersonal skills.
• Uncompromising attention to detail and the ability to think analytically.
• Organization and planning ability.
• Sound problem-solving and decision-making skills.

Responsibilities

• Prepare, compile, maintain, and support submissions related to INDs, IDEs, protocol amendments, continuing reviews, annual reports, safety reports, and other regulatory filings under the guidance of The Executive Director for the Center of Excellence for Clinical & Translational Research.
• Maintain regulatory binders, electronic regulatory files, investigator/site regulatory records, and essential documents, including investigator qualifications, training records, financial disclosures, delegation logs, laboratory certifications, and other required documentation in accordance with ICH-GCP and organizational SOPs.
• Review regulatory documents for completeness, consistency, and accuracy, and collaborate with project team members to ensure submission requirements are met.
• Serve as a regulatory contact for study sponsors, IRBs, regulatory agencies, and other oversight bodies, as applicable.
• Support IRB submissions, continuing reviews, amendments, reportable events, and study closure activities.
• Monitor updates from the FDA, Office for Human Research Protections (OHRP), IRBs, ClinicalTrials.gov, and other applicable regulatory authorities to ensure ongoing compliance with current regulations, guidance documents, and industry standards.
• Support clinical trial registration and results reporting activities in ClinicalTrials.gov, as applicable.
• Support communications and submissions to the FDA under the direction of Regulatory Affairs leadership when required.
• Provide guidance and support to study teams regarding regulatory requirements, processes, and documentation.
• Identify project needs, track timelines, and manage day-to-day workload in collaboration with the Executive Director for the Center of Excellence for Clinical & Translational Research.
• Provide regulatory support to the Safety Team and assist with the preparation, tracking, and submission of serious adverse event reports, safety reports, and other pharmacovigilance-related documentation in accordance with organizational SOPs and sponsor requirements.
• Assist with preparation for sponsor, regulatory authority, and internal audits and inspections, including documentation review and response activities.
• Follow organizational SOPs and procedural documents consistently and contribute to process improvement initiatives.
• Perform other duties as assigned.

Skills

Regulatory knowledge

Attention to detail

Communication skills

Organizational skills

Analytical thinking

Education

Bachelor's degree in life sciences or related field

Advanced degree (MS, MPH, PharmD, or equivalent)

Tools

Microsoft Office Suite

Job description

Meharry Medical College seeks a Regulatory Compliance Manager to support the Executive Director in planning, coordinating regulatory activities for clinical research projects. The role focuses on regulatory submissions, documentation, and ensuring adherence to ICH-GCP, FDA, IRB, and Common Rule guidelines.

Responsibilities include preparing submissions for INDs/IDEs, maintaining regulatory binders, reviewing documents, and serving as a regulatory contact for sponsors and authorities.