Regulatory Specialist

Mid Atlantic Retina•Philadelphia, PA

About The Position

The primary responsibility of the Regulatory Specialist is to write, and complete submission of regulatory documents to FDA and IRB and assist administratively in all areas of research. The Regulatory Specialist is responsible for collecting, recording, and managing all clinical data.

Requirements

Minimum of 2 year of experience in Regulatory Affairs in Research & Development
Candidate must have strong knowledge of regulations including GCP's & ICH guidance documents.

Responsibilities

Study start-up documentation (1572s, financial disclosure forms, site staff signature logs, informed consent modification for local IRB).
Regulatory submissions adhering to submission schedule and IRB guidelines. Submissions include protocol amendments, protocol deviations/violations, on-site and off-site SAE reporting, continuing Reviews, Supplementary materials (advertising materials) for all locations.
Maintenance of regulatory documentation for all studies and all doctors (correspondence, protocols, training requirements, training logs, curricula vitaes, current medical licenses).
Manage and maintain regulatory database.
Work closely with study monitors to ensure completeness and accuracy of regulatory documents. Site visit follow-up correspondence filed after action items completed.
Maintain current records on relevant training: Clinical Research Coordinator Training, IRB Training for Human Subjects in Research, HIPAA Training.
Schedule physician attendance and availability for IRB meetings.
Follow up on action items from IRB.
Add, maintain and provide study summaries to Clinicaltrials.gov.
Manage MAR research website (creation, additions and updates).
Managing and maintaining trial master files for all studies
Conduct internal regulatory database and trial master file audits for industry and investigator sponsored studies.
Back-up clinical research coordinators and assist with data entry and/or completion of case report forms (CRFs). Resolution of data discrepancies.
Create and maintain standard operating procedures (SOP) for research department.
Identify and communicate regulatory requirements and obstacles with the research manager, director and principal investigators.
Determine when study files can be shipped for offsite storage and destruction dates.
Update all physicians CV research study list (including start and end dates).
Attend monthly research meetings.
Travel to other Mid Atlantic Retina locations is required for this position