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
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your resume and details on file so when we see similar roles or see skillsets that drive growth in organizations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.Â
That's why we recommend registering your resume so you can be considered for roles that have yet to be created.Â
Yes, we help with CV and interview preparation. From customized support on how to optimize your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.