Clinical Research Governance Specialist

Job Summary:

The Clinical Research Governance Specialist supports the Clinical Research Compliance function by leading the management of controlled documents, study governance tools, and policy oversight activities. This role ensures the integrity and traceability of essential compliance documents, facilitates cross-functional governance processes, and maintains registries and trackers required by global regulations. A critical responsibility of this role is to manage ClinicalTrials.gov registrations and updates in full compliance with FDAAA 801 and 42 CFR Part 11. The Specialist provides independent review of governance deliverables, separate from operational compliance and QA oversight, to ensure clear separation of duties and alignment with industry standards, including FDA, ICH, ISO 14155, and EU MDR requirements.

Duties & Responsibilities:

• Lead governance committees and documentation processes, including the lifecycle management of SOPs, templates, informed consent checklists, and CVI documents.
• Manage ClinicalTrials.gov registrations and updates, including timely posting of protocols, results, and required amendments, ensuring compliance with FDAAA 801, 42 CFR Part 11, and international registry requirements.
• Maintain governance trackers, including training logs, deviation/NTF logs, and other cross-functional compliance tools.
• Facilitate governance meetings and committees by coordinating agendas, preparing documentation, recording minutes, and tracking follow-up actions.
• Review governance fields and finalize documentation for policy deliverables, ensuring independence from QA/compliance operational reviews.
• Support audit readiness and inspection preparation by maintaining governance documentation in alignment with ICH E6(R2/R3) and ISO 14155 essential document standards.
• Collaborate with Clinical Research Compliance, Quality, IT/IS, Legal, and Regulatory Affairs to ensure governance tools are aligned with organizational policies and international regulations.
• Perform other related duties, responsibilities, or special projects as assigned to support departmental and organizational objectives.

Minimum & Preferred Qualifications and Experience:

Minimum Qualifications:

• 3+ years experience in related field.
• Direct, hands-on experience with ClinicalTrials.gov registration and results reporting.
• Knowledge of Good Clinical Practice (ICH E6), FDA regulations (21 CFR Parts 11, 50, 54, 56, 812), and EU MDR 2017/745.
• Strong organizational and documentation management skills, with proven ability to maintain controlled records.
• Excellent written and oral communication skills, with demonstrated ability to coordinate cross-functional activities.
• Ability to manage multiple tasks with attention to detail under time-sensitive conditions.

Preferred Qualifications:

• Bachelor's degree in Public Health, Life Sciences, Regulatory Affairs, or related field.
• Experience with document control, governance tracking systems, and policy oversight in a regulated environment.
• Familiarity with ISO 13485 quality systems and risk-based compliance approaches.
• Professional certification (e.g., ACRP, SOCRA, RAPS) preferred.

Education:

BA/BS or equivalent years of experience required, preferably in life sciences. Advance degree in life sciences preferred.

Compensation

The anticipated salary range for this position is $69,000 - $80,000 plus benefits. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience. This position also qualifies for up to 10% annual bonus based on Company, department, and individual performance.

Physical requirements/Work Environment

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Travel may be necessary depending on business need. Approximately 5-10% travel, both domestic and international. Travel requirement is subject to change based on business needs.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodation may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.