Regulatory Associate

Position Summary

The Regulatory Associate position is responsible for supporting the Regulatory Administrator through coordinating and documenting internal regulatory processes, such as internal audits, inspections, license renewals, or registrations across multiple studies. This position collaborates with multiple IRBs, sponsoring companies, and co-workers to ensure study documents receive approval and are made available to the site in a timely manner.

Position Responsibilities

• Facilitate the protocol approval process and maintain documentation of regulatory compliance throughout the trial’s duration for research studies.
• Maintain and update all internal and external protocols, data collection sheets, spreadsheets, and databases for use in gathering and compiling information specific to each research process.
• Develop, maintain, utilize, and update all internal and external protocols, data collection sheets, spreadsheets, and databases for use in gathering and compiling information specific to each research process.
• Monitor, detect, and report adverse events meeting requirements of regulatory bodies in a timely manner.
• Coordinate activities and gather information from a variety of sources to achieve stated outcomes.
• Complete and maintain regulatory documents for all study personnel, including CVs, licenses, Form FDA 1572, confidentiality agreements, and delegation of duties logs.
• Compile and maintain Paper Investigator Site File (ISF) binders and eISF.
• Complete regulatory applications and other required documentation, prepare protocol specific forms for submission to various review committees, including review boards, the IRB, and sponsors.
• Support the Regulatory Administrator and VP of Study Operations in the day-to-day activities of regulatory safety management for patients enrolled on research protocols.
• Complete protocol renewal applications, amendment applications, and maintain records of all adverse event reports.
• Attend research team meetings to report on regulatory issues.
• Aid in the creation and maintenance of protocol specific training documents.
• Communicate with CRAs at on-site and/or remote monitoring visits and assist with necessary regulatory tasks.
• Other duties as assigned.

Requirements

• Excellent communication, interpersonal, analytical, and problem-solving skills.
• Microsoft Office Suite proficiency.
• Writing and verbal communication skills.
• Solid understanding of regulations governing clinical research (CFR, GCP, HIPAA).
• Previous experience in a clinical research setting or related work environment.
• Familiarity with or ability to learn clinical trial management system software.

Physical Requirements

• Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel.
• Ability to lift and/or move up to 20 pounds.

About the Role

Associates degree plus two years related work experience or an equivalent combination of relevant post-secondary education and work experience that equals 4 years is required, bachelor’s degree is preferred. Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA) and solid understanding of statutes and guidelines relevant to regulatory affairs in clinical research.

Benefits

Qualified candidates will be contacted for interviews. Unleash your potential and apply today!

Pay

N/A

Schedule

N/A

Skills

Self-motivated, multi-tasking, quick learner, results-oriented, and able to meet deadlines.

Qualifications

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.