Research Regulatory Specialist
About The Position
As our Research Regulatory Specialist, you will play a pivotal role in advancing cutting-edge clinical studies. We are seeking a meticulous and detail-oriented professional with a passion for clinical research and regulatory compliance. Every day you will coordinate and participate in clinical research studies, ensuring seamless operations from start to finish. You'll be responsible for the meticulous collection, documentation, and reporting of vital clinical research data, contributing directly to program management and grant funding success. To be successful in this role, you will be responsible for study coordination, schedule subject study visits, ensuring adequate supplies, procedures, and investigator availability. Provide study-specific, individualized education to study subjects and their families. Ensure all appropriate subject consents are obtained. Collect and process protocol-required specimens. Act as a crucial liaison between the Sponsor, Investigator, and Study Subject.
Requirements
- Associate's degree in a related field OR an equivalent combination of relevant education and job-related experience in lieu of a degree
- Minimum of Two (2) years of related experience in clinical research or regulatory affairs
- Competency in computer skills, including strong proficiency with Microsoft Office products (Word, Excel, Outlook, PowerPoint)
- Proven ability to coordinate and manage multiple tasks with high attention to detail
- Strong understanding of clinical trial processes and regulatory requirements (FDA, OHRP, IRB)
- Excellent written and verbal communication skills, including the ability to educate subjects and families effectively
- Proficiency in data collection and reporting
- Exceptional organizational and time management abilities
- Ability to work independently and as part of a collaborative team
Nice To Haves
- Bachelor's degree in a related field
- Three (3)+ years of clinical experience
Responsibilities
- Coordinate and participate in clinical research studies.
- Meticulously collect, document, and report clinical research data.
- Contribute to program management and grant funding success.
- Coordinate study activities, including scheduling subject visits.
- Ensure adequate supplies, procedures, and investigator availability.
- Provide study-specific education to subjects and their families.
- Ensure all appropriate subject consents are obtained.
- Collect and process protocol-required specimens.
- Act as a liaison between the Sponsor, Investigator, and Study Subject.
- Collect all required study data and complete CRFs (Case Report Forms) in a timely and accurate manner.
- Prepare comprehensive project reports related to program management and grant funding.
- Ensure study documents are maintained in strict compliance with applicable regulations, guidelines, and policies (e.g., FDA, OHRP, IRB).
- Collaborate closely with investigators to identify adverse events and serious adverse events, ensuring subject safety and accurate, timely reporting.
- Demonstrate exceptional internal and external customer service through professional interactions with Sponsors, study monitors, and internal departments.
- Comply with all regulatory and policy requirements.
- Maintain and apply deep knowledge of federal and state regulations, guidelines, and policies governing the conduct of clinical trials.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
