Salary: $85-95K
Company Summary: A global, specialty pharmaceutical group with an impressive track record is seeking a motivated Study Start Up Specialist for a hybrid role in San Francisco (Palo Alto). Their commercial supply of pharmaceutical products generated $83m in revenue in FY2023 (a 24% uptick from the year prior during a year of record layoffs). Since their first clinical trials in 2006, they've had 3 approvals already on the market. Currently, they have 6 indications in Phases II and III, and are building out their clinical team to support a large Ph. III study.
***** Candidate must be based in SF Bay Area to be considered.*****
The Study Start Up Specialist will be responsible for:
* Conducting site start-up activities and timely initiation of sites for clinical trials (1-2x per quarter)
* Feasibility assessments/visit evaluations for clinical and post-authorization studies, as required
* Supporting site management activities: investigating, following up on, and escalating site issues as needed.
* Assisting with pharmacovigilance, safety reporting management, and investigations of quality complaints.
* In-house/on-site document quality management (including, but not limited to, trial master file and investigator site file).
An ideal candidate for this role MUST have…
* Graduate qualifications in Biological Sciences, Nursing, Pharmacy, or related discipline
* At least 1 year of experience as a Clinical Research Assistant or higher
* Working knowledge of ICH GCP guidelines
* Proven experience in supporting clinical trials/projects
Benefits:
* Competitive salary with benefits
* High degree of commercial exposure early in your career
* Being a part of team whose work directly aims to improve the quality of people's lives
* Great work-life balance
If you are interested in this Study Start Up Specialist role, don't hesitate to reach out!
