Clinical Research Associate
San Francisco Bay Area
Salary: $90,000-$110,000
A global specialty biopharma company is looking for new members to join their clinical team on a full time basis as they ramp up a large global Ph. 3 study.
They currently have 8 indications across 2 programs ranging from preclinical to Ph. 3. They've also had 3 approvals in various global markets for their lead asset. This company has had year over year revenue growth for the past three years.
This role is remote with plans to transition to hybrid with a 2-3 day in office requirement, and their entire US team is located in the SF Bay Area.
The Clinical Trial Specialist will be responsible for:
- Oversee site management, including the supply of materials, payment processes, and related activities.
- Manage site setup, initiation, monitoring, close-out, and overall management of clinical and post-authorization study sites on an as-needed basis.
- Collaborate with the Clinical Project Manager or designee for site evaluation and setup related to commercial distribution, including dosing training.
- Track and report on the status of clinical trials and studies, providing regular progress updates to the team.
- Oversee data collection and pharmacovigilance/safety reporting at post-authorization study sites.
- Ensure the collection of essential documents in compliance with ICH-GCP E6 (R2) and applicable regulations.
- Prepare and submit regulatory documents to EC/IRB and other relevant bodies.
- Maintain relationships with commercial distribution sites and those involved in clinical trials.
- Participate in investigator meetings
The Clinical Trial Specialist should have the following qualifications:
- Graduate qualifications in Biological Sciences, Nursing, Pharmacy or related discipline
- At least 2 years proven experience as a CRA
- Working knowledge of ICH GCP guidelines
- Proven experience in managing clinical trials/project
Benefits:
- A competitive salary with benefits.
- A real hands-on opportunity to gain a high degree of commercial exposure.
- Working with highly-talented and dedicated colleagues in a fast-growing company that combines a focus
on cutting-edge science with commercial delivery
If you are interested in the Clinical Trial Specialist role, then please don't wait to apply.
