Cumberland Valley Retina · 17 hours ago
Clinical Research Regulatory Specialist
United States
Full-time
Remote
Mid Level
3+ years expCumberland Valley Retina is seeking a Clinical Research Regulatory Specialist to oversee regulatory compliance activities across clinical research protocols and study sites. This role involves managing regulatory document submissions, ensuring compliance with IRB and FDA regulations, and maintaining audit readiness throughout the research process.
ConsultingHealth CareHealth Diagnostics
Responsibilities
Maintain full regulatory compliance oversight across all active clinical trials and study sites
Ensure timely and accurate IRB submissions, renewals, amendments, and continuing reviews
Serve as the primary owner of electronic regulatory document management and inspection readiness
Prevent regulatory lapses through proactive deadline tracking and training documentation control
Partner with study teams to ensure certifications, training logs, and regulatory requirements remain current
Maintain full regulatory responsibility for assigned clinical research protocols from startup through closeout
Ensure ongoing compliance with all applicable requirements, including:
IRB regulations
FDA regulations
ICH-GCP guidelines
Sponsor and CRO expectations
Institutional policies and SOPs
Identify regulatory risk proactively and implement mitigation strategies to prevent compliance lapses
Ensure that all regulatory processes and documentation standards remain audit-ready at all times
Lead and execute all IRB-related activities across study sites, including:
Initial submissions
Amendments
Continuing reviews
Safety notifications
Protocol deviations and reportable events
Maintain master regulatory calendars and submission trackers to ensure all deadlines are met without exception
Proactively escalate upcoming expirations or regulatory risks to the Research Manager to avoid negative site implications
Maintain complete and compliant electronic regulatory files using systems such as Veeva eReg or equivalent
Ensure accurate version control, document completeness, and sponsor-ready formatting for all essential regulatory documents
Oversee ongoing maintenance of regulatory binders and electronic filing structures, including:
Investigator and site documents
IRB approvals and correspondence
Financial disclosure documentation
Delegation of authority logs
Training documentation
Serve as the regulatory owner of all required study team training compliance, including:
GCP certifications
Protocol-specific training completion
Training logs and documentation
Investigator and staff credential tracking
Ensure delegation logs are accurate, current, and aligned with staff responsibilities and protocol requirements
Partner closely with study coordinators and leadership to ensure training completion is documented timely to prevent sponsor findings or compliance gaps
Serve as a primary regulatory point of contact for sponsor and CRO regulatory requests
Ensure timely responses to sponsor queries, regulatory document requests, and site readiness needs
Coordinate regulatory support for:
Pre-Study Site Visits (PSSVs)
Site Initiation Visits (SIVs)
Ongoing monitoring visits
Closeout visits
Attend all SIVs remotely and ensure regulatory readiness requirements are fully met prior to activation
Maintain consistent, professional, and timely email correspondence with all external stakeholders, including Sponsors, CROs, IRBs, and regulatory partners
Serve as a reliable regulatory communication owner, ensuring that all regulatory requests, document submissions, and compliance-related inquiries are acknowledged and addressed within required timelines
Draft and deliver accurate written responses that reflect the highest standards of professionalism, regulatory integrity, and site accountability
Escalate time-sensitive issues or regulatory risks immediately to the Research Manager to prevent delays, findings, or negative site implications
Maintain continuous audit and inspection readiness across all assigned studies
Support sponsor audits, CRO audits, and regulatory inspections by:
Preparing essential documentation
Participating in audit activities
Coordinating follow-up responses
Conduct routine internal regulatory reviews to identify gaps before external findings occur
Assist in corrective and preventive action (CAPA) development and resolution when required
Work closely with the Research Manager and research operations team to ensure regulatory requirements align with study execution timelines
Participate in all required departmental meetings remotely with consistent engagement and accountability
Serve as a regulatory resource to coordinators and study staff to support compliance questions, document needs, and training requirements
Contribute to regulatory SOP development, refinement, and implementation as required
Maintain clear and timely internal communication with study coordinators, protocol managers, investigators, and leadership to ensure regulatory deadlines, training requirements, and submission obligations are never missed
Provide proactive written updates and escalation emails regarding:
Upcoming IRB expirations
Outstanding training or certification gaps
Missing essential documents
Sponsor/CRO regulatory action items
Demonstrate exceptional attention to detail, accountability, and urgency in regulatory deadline management
Maintain absolute integrity, confidentiality, and professionalism in all regulatory processes
Operate proactively to prevent lapses that could jeopardize site standing or sponsor confidence
Communicate clearly, consistently, and promptly with research leadership, coordinators, sponsors, and IRBs
Uphold the highest standards of regulatory excellence, audit readiness, and documentation quality
Demonstrate exceptional written communication skills with consistent professionalism in all internal and external correspondence
Ensure all regulatory communication is responsive, complete, and audit-appropriate, reflecting the site’s commitment to excellence and compliance
Operate with urgency and accountability in sponsor and CRO interactions to maintain strong external partnerships and protect site reputation
Qualification
Required
Minimum of 3 years of direct clinical research regulatory management experience, with full oversight responsibilities
Demonstrated experience independently managing: IRB submissions, continuing reviews, amendments, study startup and closeout regulatory requirements
Strong knowledge of FDA regulations, ICH-GCP, IRB processes, and sponsor/CRO compliance standards
Proficiency with electronic regulatory document management systems, including Veeva or equivalent platforms
Strong organizational and deadline management skills with proven audit-ready performance
Preferred
Retina or ophthalmology clinical research experience
Experience supporting multi-site regulatory oversight
Bachelor's degree in life sciences, clinical research, healthcare administration, or related field
Company
Cumberland Valley Retina
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase