Study Start up and Regulatory Specialist

Study Start up and Regulatory Specialist Orange County Research Center - 4.1 Lake Forest, CA Job Details Full-time $51,439.34 - $61,948.45 a year 5 hours ago Benefits Health insurance Dental insurance 401(k) Flexible spending account Paid time off Vision insurance 401(k) matching Life insurance Qualifications Record keeping Teamwork Clinical research ICH guidelines Research compliance clinical trial records management Organizational skills Productivity software Training & development Document management systems Health informatics FDA regulations Full Job Description Orange County Research Center is seeking an experienced Regulatory and Study Start-Up Specialist to join our clinical research team. This position will support regulatory document management, study start-up activities, sponsor and CRO communications, and the maintenance of study files for clinical trials. The ideal candidate will be detail-oriented, organized, proactive, and highly experienced in managing regulatory requirements in a fast-paced clinical research environment. Knowledge and hands-on experience setting up and maintaining electronic Investigator Site File systems is required. Key Responsibilities The Regulatory and Study Start-Up Specialist will be responsible for coordinating and maintaining regulatory documents and study start-up activities from site selection through study activation.

Responsibilities include:

Prepare, collect, review, and maintain essential regulatory documents for clinical trials. Set up and maintain electronic Investigator Site File systems, including sponsor/CRO portals and site-managed eISF platforms. Ensure regulatory files are complete, current, inspection-ready, and compliant with

GCP, FDA

regulations, ICH guidelines, sponsor requirements, and site SOPs. Coordinate study start-up activities, including feasibility support, CDA tracking, regulatory packet completion, site activation requirements, and document submissions. Work closely with sponsors, CROs, investigators, study coordinators, and internal departments to ensure timely study activation. Track training documentation, delegation logs, licenses, CVs, medical licenses, financial disclosures, GCP certificates, and other required essential documents. Support IRB submissions, continuing reviews, amendments, safety reports, and regulatory correspondence as needed. Maintain accurate logs, trackers, and regulatory binders/files throughout the life of the study. Assist with audit and monitoring visit preparation and respond to regulatory document requests. Support study start-up tracking Required Qualifications Prior experience in clinical research regulatory affairs, study start-up, or clinical trial administration. Required experience setting up and maintaining electronic Investigator Site File systems . Strong understanding of

GCP, ICH

guidelines, FDA regulations, and essential regulatory documentation. Experience working with sponsor and CRO portals and electronic document systems. Excellent organizational skills and strong attention to detail. Ability to manage multiple studies, deadlines, and competing priorities. Strong written and verbal communication skills. Proficiency with Microsoft Office, Adobe, electronic document management systems, and study tracking tools. Ability to work independently and collaboratively with investigators, coordinators, sponsors, CROs, and internal teams. Preferred Qualifications Experience in Phase I-IV clinical trials. Experience working at a clinical research site. Familiarity with IRB submissions and central IRB platforms. Experience supporting sponsor qualification visits, site initiation visits, monitoring visits, and audits. Knowledge of clinical trial start-up timelines and site activation requirements. Ideal Candidate The successful candidate will be highly organized, dependable, and comfortable managing regulatory documents across multiple studies. They must be able to maintain inspection-ready files, communicate professionally with sponsors and CROs, and take ownership of study start-up tasks from initiation through activation. About Orange County Research Center Orange County Research Center is an experienced clinical research site located in Lake Forest, California. Our team conducts clinical trials across a variety of therapeutic areas and is committed to quality, compliance, patient safety, and efficient study execution.

Pay:

$51,439.34 - $61,948.45 per year

Benefits:

401(k) 401(k) matching Dental insurance Flexible spending account Health insurance Life insurance Paid time off Vision insurance Application Question(s): What eISF systems have you used?

Experience:

Regulatory:

2 years (Required)

Work Location:

In person