Clinical Regulatory Start-Up Specialist (On-Site)

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

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) match

Tuition reimbursement

Parental leave

Employee referral program

Life insurance

Disability insurance

PTO

Job summary

Flourish Research, based in Walnut Creek, CA, seeks a Regulatory Specialist to manage regulatory documents across clinical studies. The role covers start-up, submissions, and ongoing regulatory support onsite at the Walnut Creek site.

The ideal candidate will have strong regulatory knowledge, proficiency with MS Office, and experience with CTMS/eRegs/eDocs. This is a full-time, on-site position with a Monday–Friday day shift.

Qualifications

• Prepare, maintain and provide oversight to all research-related regulatory documents.
• Coordinate submission of documents to IRB, sponsors and regulatory offices.
• Assist in study start-up, delegation and training activities.

Responsibilities

• Prepare regulatory documents and oversee their accuracy.
• Submit initial, continuing and final regulatory materials to IRB/sponsors.
• Maintain logs and archival files for regulatory records.
• Assist in monitoring visits and audits as needed.
• Coordinate collection of site regulatory documents and training certificates.

Skills

Regulatory documentation

IRB submissions

Attention to detail

Communication skills

Education

High School Diploma

College degree preferred

Tools

Microsoft Office

CTMS

eRegs/eDocs

IRB coordination

Job description

Flourish Research, based in Walnut Creek, CA, seeks a Regulatory Specialist to manage regulatory documents across clinical studies. The role covers start-up, submissions, and ongoing regulatory support onsite at the Walnut Creek site.

The ideal candidate will have strong regulatory knowledge, proficiency with MS Office, and experience with CTMS/eRegs/eDocs. This is a full-time, on-site position with a Monday–Friday day shift.