**Hybrid in Newark, CA**
Job opportunity with a top biopharmaceutical company that is looking for a Sr. CTA to join their team on a 6-month contract with a possibility for conversion or extension!
Pay Rate: $65-$75/hr
Qualifications:
- Bachelor's degree or equivalent training and experience (i.e., technical degree)
- Experience supporting studies in a fast-paced environment
- Success in working with CROs and vendors
- 1-3+ years of clinical study experience with time at a sponsor company preferred
Job Description/Skills:
- Assist the team in ensuring that quality clinical trials are conducted per protocol, in a timely fashion, and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals, and established study budgets
- Create, maintain and track information for key study activities and needs (e.g. study contact list, site start-up, enrollment, etc.)
- Create and maintain access to various systems for the conduct of clinical trials such as lab, imaging, IxRS, eTMF, etc.
- Assists study vendor managers to track the progress of studies and to ensure the studies are running smoothly
- Create and maintain the study file folders on Box to support the ongoing clinical documentation
- Assist with other key clinical activities such as Frequently Asked Questions (FAQ), reconciliation activities (lab samples etc.) as needed
- Coordinate with legal execution of Non-Disclosure and Confidentiality Agreements (NDAs, CDAs) with study sites
- Assist Execution Team Leader (ETL) in budget management activities including but not limited to reviewing, tracking, and maintaining clinical operational vendor invoices to ensure accuracy to the scope of work and obtaining approval from the Execution Team Leader (ETL) or designee
- Obtain, review, and track site-specific regulatory packets for completeness and accuracy for site activation and drug shipment
Benefits/Perks:
- 401k
- Health Insurance
Please apply here directly if interested but If you are genuinely not interested, is there someone you can recommend?