Clinical Research Regulatory Manager

We are seeking a Clinical Research Regulatory Manager for an upcoming contract project. Please find details below, and if you're interested, apply here to be considered.

Project Dates: Immediate 4-mo contract, likely to extend as this is a long-term trial.

Location: Remote

Rate: Market rates, let's discuss

Description:

The Clinical Research Regulatory Manager supports clinical research activities through the development of regulatory policies and protocol-specific documents including all reports for research activities from initial submission through study closure. The primary focus for this position is on development, submission, maintenance, filing and reporting of regulatory documents to achieve and maintain compliance with all internal, external, and federal policies and regulations pertinent to research involving human subjects.

This position is responsible for the management of the PAS Quality Management System, serves as the regulatory expert in the organization, provides regulatory guidance and direction through the leadership of the PAS Compliance Workgroup, and ensures compliance with all applicable policies, procedures, and regulations for clinical research.

Responsibilities:

• Ensures the PAS Quality Management System (QMS) is up to date per regulatory and sponsor requirements and maintains assessment/audit processes and documentation
• Coordinates review, approval, and dissemination of policies with the internal compliance committee
• Train employees
• Ensures that regulatory binders are audited and maintained
• Develops and maintains departmental and study level SOPs in relation to clinical trials and according to FDA regulations and GCP guidance
• Leads the PAS Compliance Workgroup in the maintenance of PAS’s controlled documents (policies, SOPs, checklists, etc.)
• Tracks status of pending protocols and associated supporting documents to provide efficient customer service to the Research team
• Follows-up, communicates and facilitates responses to queries of the IRB, Sponsor, and other committees because of their review of submissions
• Helps to coordinate process, regulatory documents, queries and submissions during sponsor and FDA audits
• Work with sponsor to facilitate and coordinate the timely and accurate submission of safety date (AEs/SAEs), regulatory documents (hard copies and electronic binders) and IRB submissions by collaborating with research nurses, clinical research coordinators, and investigators in the preparation of regulatory documents.
• Coordinates the preparation and submission of all regulatory documents for a research study, including but not limited to consent forms, form 1572, IDE, and IND applications, in compliance with the regulatory requirements of federal, state, and local agencies governing biomedical research
• Has GCP training and follows GCP guidelines and other guidelines related to the conduct of human subject’s research
• Prepares, facilitates, and coordinates the process for accurate and timely submission of Institutional Research Board (IRB) applications for initial submissions, protocol revisions or amendments to reflect any new treatment procedures, administrative changes, changes in subject population, funding, recruitment procedures, site changes, changes in the informed consent, or dual enrollment to additional studies for IRB approved protocols as required by federal regulations and internal policy
• Facilitates trial registration, results and reporting to sponsor and regulatory agencies such as the FDA, clinicaltrials.gov etc., in a timely manner consistent with federal regulations.
• Supports in the preparation and conduction of vendor assessments and supports in the resolution of assessment findings/observations

Required Qualifications:

• Bachelor’s Degree
• SOP development and compliance oversight
• 5 Years minimum regulatory experience in clinical trials
• FDA regulated industry experience
• Audit preparation and conduct
• Pre-market regulatory affairs experience
• Independent judgment
• Quality Management System/Regulatory Compliance Program
• Regulatory certification from AAAHRP, SOCRA, PRIM&R or similar organizations
• GCP training and/or certification

Preferred Qualifications

• Experience gained from multiple perspectives: industry sponsor, CRO, academic, government or site level
• 5-10 years of clinical trial regulatory management experience.
• Master’s Degree

Eligibility Requirements:

• May be required to complete a background check
• Only US Citizens and VISA holders
• No third parties