Clinical Trials Regulatory Specialist, Start-Up Focus

RiseMe; Walnut Creek (CA); On-site; USD 34,000 - 37,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

401(k) with employer match

Tuition reimbursement

Parental leave

Employee assistance program

Life insurance

Disability insurance

Paid holidays

Generous PTO

Job summary

Flourish Research in Walnut Creek, CA is seeking a Regulatory Specialist to create, maintain and coordinate regulatory documents for clinical studies in accordance with SOPs, GCP, IRB and sponsor requirements. This is an onsite, full-time role.

You will lead study start-up, prepare submissions, monitor visits, maintain logs, protect PHI, and collaborate with sponsors, CROs, IRBs, and site staff to ensure timely, compliant study conduct.

Qualifications

• High School Diploma or equivalent required; college degree preferred but not required.
• Experience in clinical or biological research is a plus (0-3+ years).
• Must be detail oriented, organized, and able to work independently and on a team.

Responsibilities

• Prepare and oversee regulatory documents for research.
• Coordinate submissions to IRB, sponsors, and regulatory bodies.
• Submit initial, continuing and final reports to IRB/sponsor.
• Prepare submission forms and updated documents (Amendments, Addendums, ICH, etc).
• Maintain logs in regulatory repositories and archives.
• Assist in monitoring visits and audits.
• Distribute, collect, process and track regulatory documents (CVs, licenses, GCP, etc).
• Maintain confidentiality of PHI and study protocol information.
• Create error-free written documents and reports.
• Perform duties safely and cost-effectively.
• Represent Flourish Research professionally with sponsors, CROs, IRBs, sites; interact with staff.
• Additional duties as assigned.

Skills

Attention to detail

Communication

Independent and team work

Time management

Education

High School Diploma

College degree (preferred)

Tools

Outlook

Word

Excel

CTMS system

eRegs/eDocs

Job description

Flourish Research in Walnut Creek, CA is seeking a Regulatory Specialist to create, maintain and coordinate regulatory documents for clinical studies in accordance with SOPs, GCP, IRB and sponsor requirements. This is an onsite, full-time role.

You will lead study start-up, prepare submissions, monitor visits, maintain logs, protect PHI, and collaborate with sponsors, CROs, IRBs, and site staff to ensure timely, compliant study conduct.