Regulatory Specialist Jobs

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

Project duration: 6 months with possibility for extension - immediate need

Location: 100% Remote based out of Charlotte, NC; no travel required

Rate: Around $50-60 per hour

No third parties or Corp to Corp please.

Description:

The Clinical Research Regulatory Specialist 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.

Responsibilities:

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

Job Duties:

• Ensures that regulatory binders are audited and maintained
• Ensures the Quality Management System (QMS) is up to date per regulatory and sponsor requirements and maintains assessment/audit processes and documentation
• Follows-up, communicates and facilitates responses to queries of the IRB, Sponsor, and other committees because of their review of submissions
• Has GCP training and follows GCP guidelines and other guidelines related to the conduct of human subject’s research
• 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.
• Develops and maintains departmental and study level SOPs in relation to clinical trials and according to FDA regulations and GCP guidance
• 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.
• Helps to coordinate process, regulatory documents, queries and submissions during sponsor and FDA audits
• Leads the Compliance Workgroup in the maintenance of controlled documents (policies, SOPs, checklists, etc.)
• 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
• Supports in the preparation and conduction of vendor assessments and supports in the resolution of assessment findings/observations
• Coordinates review, approval, and dissemination of policies with the internal compliance committee
• Tracks status of pending protocols and associated supporting documents to provide efficient customer service to the Research team
• 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

Qualifications:

• SOP development and compliance oversight
• Regulatory certification from AAAHRP, SOCRA, PRIM&R or similar organizations
• Pre-market regulatory affairs experience
• Audit preparation and conduct
• Bachelors Degree
• Independent judgment
• 3 Years Applicable Experience
• Quality Management System/Regulatory Compliance Program
• FDA regulated industry experience
• GCP training and/or certification

Eligibility Requirements:

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