Legal, Regulatory & Ethics
The guardians of participant protection and lawful conduct — human-research protection, regulatory submissions, quality systems, and transparency.
Who belongs here: Human research protection managers, IRB liaisons, regulatory affairs and IND specialists, QA auditors, TMF and document control, GCP trainers, CAPA managers, privacy analysts.
20 roles
Human Research Protection Program Manager
Legal, regulatory & ethics · Runs the human-research protection program: IRB submissions, consent documents, and SOPs.
IRB Liaison
Legal, regulatory & ethics · Manages IRB submissions, continuing review, amendments, and reportable events.
Bioethicist
Legal, regulatory & ethics · Working bioethics review of protocols, consent, and publication ethics — independent counsel on participant protection, equity, and honest reporting, distinct from the volunteer Ethics Advisory Board.
Regulatory Affairs Specialist
Legal, regulatory & ethics · FDA/IRB experience and botanical / dietary-supplement / drug classification familiarity.
IND / FDA Submissions Specialist
Legal, regulatory & ethics · IND preparation, eCTD familiarity, and FDA correspondence.
ClinicalTrials.gov / PRS Manager
Legal, regulatory & ethics · Trial registration and results reporting on the required timelines — central to our transparency commitments.
Trial Master File Specialist
Legal, regulatory & ethics · TMF/eTMF, essential-documents checklists, and inspection readiness.
QA Auditor
Legal, regulatory & ethics · GCP/GMP/GLP auditing as relevant, with independence disclosure.
SOP Writer
Legal, regulatory & ethics · Clear, compliant standard operating procedures and quality documentation.
GCP Trainer / Training Coordinator
Legal, regulatory & ethics · GCP/HSP training delivery, LMS experience, and training records.
CAPA Manager
Legal, regulatory & ethics · Root-cause analysis and corrective/preventive action within quality systems.
Privacy & Records Compliance Analyst
Legal, regulatory & ethics · Privacy and security practice, retention schedules, and breach-response familiarity.
Director of Regulatory Affairs
Executive & scientific leadership · Leads regulatory strategy across IND/FDA/IRB and botanical classification questions.
Director of Quality Assurance / GCP Compliance
Executive & scientific leadership · Owns the quality system: audits, SOPs, CAPA, and inspection readiness.
Senior Attorney
Legal & general counsel · Handles substantive legal work across contracts, corporate and nonprofit governance, intellectual property, employment, privacy, and research agreements, and mentors junior legal staff. Active bar admission and several years of relevant practice.
Junior Attorney
Legal & general counsel · Supports contracts, compliance, vendor and research agreements, corporate filings, and legal research under supervision. Active bar admission; early-career attorneys welcome.
Paralegal
Legal & general counsel · Drafts and manages contracts, corporate records, filings, and matter files, and supports the attorneys with legal research and document management. Paralegal experience or certificate preferred.
Legal Assistant
Legal & general counsel · Administrative support for the legal function: scheduling, document handling, filing, records management, and correspondence. Strong organization and discretion.
General Counsel / Nonprofit Counsel
Legal & general counsel · Nonprofit, clinical-research, and privacy law. Bar status, practice areas, and conflicts.
Regulatory Affairs Intern
Fellowship & early-career bench · Mentored internship in regulatory and compliance work with a writing sample.