Clinical Quality and Regulatory Lead

OVERVIEW

We are seeking a proactive and detail-oriented Clinical Quality & Regulatory Lead to join our growing clinical team. This hybrid role blends operational oversight, regulatory compliance, and quality assurance to ensure our trials are executed at the highest standard. You will be integral in managing study sites, preparing and submitting regulatory documentation, maintaining audit-ready records, and supporting site staff with training and guidance. In addition, you will oversee internal monitoring and quality programs, ensuring data integrity, adherence to protocols, and compliance with ICH-GCP, FDA regulations, and company SOPs.

This role requires strong organizational skills, the ability to self-motivate while collaborating effectively with cross-functional teams, and the judgment to proactively identify and resolve compliance risks. You will serve as a key communication conduit between study sites, sponsors, and the clinical operations leadership team, ensuring issues are addressed quickly and effectively, and that all documentation is accurate, timely, and complete.

Please note, to help us best identify qualified candidates, this job posting has several screening questions as part of the applicant process, all of which are reviewed by the hiring team, not AI. Responses of N/A or generated using AI assistance will be disqualified from consideration.

KEY RESPONSIBILITIES

Prepare, submit, and manage regulatory documents, including IRB submissions, amendments, and renewals.

Maintain audit-ready regulatory binders, source documents, and case report forms (CRFs).

Serve as the main point of contact for central and local IRBs.

Support monitoring visits and sponsor inspections by preparing documentation and facilitating communication.

Manage electronic regulatory binder and ensure timely, accurate record keeping.

Conduct, initiation, monitoring, and close-out visits remotely for assignedstudy sites from a regulatory component

Develop and execute Clinical Quality Management Plans (CQMPs) and internal data monitoring plans.

Perform routine quality control checks and targeted 10% data quality reviews to ensure adherence to ALCOA-C and regulatory standards.

Verify accuracy, completeness, and timely reporting of adverse events, serious adverse events, and protocol deviations.

Identify and escalate unreported deviations from protocols or SOPs, ensuring CAPAs are implemented.

Establish and maintain internal quality programs and quality management systems.

Draft, review, and improve SOPs and work instructions to ensure effective documentation of processes.

Develop and execute Corrective and Preventive Action (CAPA) plans, monitoring effectiveness and sustainability.

Provide operational expertise and readiness for internal and external audits (FDA, sponsor, QA vendors).

Facilitate and host audits and inspections, ensuring effective resolution of findings.

Identify training gaps across clinical operations; design, deliver, and track training/retraining programs.

Mentor site staff and CRCs in protocol adherence, GCP compliance, and documentation standards.

Work collaboratively with investigators, site staff, CRCs, CTLs, and site managers to support regulatory submissions and quality activities.

Develop strong working relationships with investigators and sponsors to ensure smooth study execution.

Conduct eligibility (or chart) reviews of patients in screening for interventional trials across the Topography network

Contribute to cross-functional initiatives to improve compliance, efficiency, and site performance.

Other tasks as assigned by your manager.

MINIMUM QUALIFICATIONS

Bachelor’s degree in health sciences, life sciences, or related discipline; or equivalent 4+ years of work experience

4+ years of clinical research experience, including 2+ years in regulatory/quality oversight and 2+ years in direct site monitoring (CRA experience strongly preferred)

4+ years of experience preparing for, supporting, or hosting audits/inspections (FDA, sponsor, or QA vendors)

4+ years of Phase II-IV clinical trial experience

PREFERRED QUALIFICATIONS

Professional clinical research certification (e.g., CCRC, CCRP, SOCRA, ACRP)

Experience leading project teams or mentoring clinical staff

Located in or around Baltimore MD, Denver CO, Detroit MI, Madison WI, Washington DC