Study Start Up Specialist

Study Start-Up Specialist

Location: San Mateo, CA (Hybrid - 3 days onsite)

Type: Full-Time, Permanent

Compensation: 75,000 - 90,000 annually + bonus + benefits

Are you passionate about clinical research and want to play a key role in bringing innovative therapies to patients?

We are partnered with a sponsor that is seeking a Study Start-Up Specialist to join our dynamic team and support the initiation of clinical trials across North America.

Responsibilities:

• Identify and evaluate potential research sites through feasibility assessments.
• Engage with site staff to foster collaboration and ensure readiness for study initiation.
• Organize and support contract negotiations.
• Prepare and submit regulatory documents to IRBs and other authorities.
• Conduct Site Initiation Visits (SIVs) and train site staff on protocols and procedures.
• Coordinate study supplies and ensure timely delivery.
• Track and report progress to ensure timely start-up of studies.
• Communicate effectively with internal teams, vendors, and research sites.
• Assist with audits, process improvements, and other clinical operations tasks.

Qualifications:

• Bachelor's degree in Biological Sciences, Nursing, Pharmacy, or related field.
• Minimum 1 year of experience as a Clinical Research Assistant or similar role.
• Working knowledge of ICH GCP guidelines.
• Strong organizational and communication skills.
• Ability to manage multiple priorities and work in a fast-paced environment.

Travel: 20 - 30% travel