Sr. Clinical Research Associate
965 Atlantic Avenue Alameda, CA 94501 | Contract
Bayside Solutions is seeking a Sr. Clinical Research Associate to be part of our Client’ s team in the East Bay Area. This is an opportunity to work with a local Pharmaceutical company focusing on the developing and commercializing novel products.
Our Client’ s culture is that of a small family-oriented organization with a focus on improving treatment options for patients. They have successfully marketed products and are in the process of working on 3 large Phase III clinical trials. The ideal person for this role will be an experienced Sr. CRA with strong Phase III experience, flexibility to travel domestically up to 40%, and experience working on smaller teams with minimal supervision.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Sr. Clinical Research Associate
- An opportunity to join a patient-focused organization with the goal to provide patients and physicians with improved treatment options.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, commuter benefits, and 401K.
Summary of Responsibilities:
- Responsible for managing day-to-day activities associated with the execution of clinical trials.
- Contribute to the selection and management of CRO’ s and vendors for the conduct of clinical studies.
- Contribute to the review and negotiation of investigational site, CRO, and vendor budgets and agreements.
- Contribute to the development of study documents, study management plans, protocols, investigator brochures, clinical study reports, and other documents and forms.
- Assemble and/or review regulatory essential documents for shipment of clinical supplies.
- Coordinate the manufacture and shipment of clinical supplies to investigators.
- Provide clinical study oversight through site management, on site and remote monitoring or co-monitoring, and review of monitoring visit reports.
- Oversee CRO clinical trial master file progress; review and evaluate regulatory essential documents for completeness and accuracy; maintain Company TMF.
- Oversee timely data entry by investigational sites; assess protocol adherence; review, evaluate, and clean data; proactively identify query trends and support additional training.
- Ensure triage, resolution, follow-up, and documentation of site- or study-level issues.
- May participate in planning and executing Investigators’ Meetings or other training sessions.
- Create and/or implement tracking systems to document study progress.
- Bachelor' s Degree with 6+ years’ experience working as a CRA/Sr. CRA at a pharmaceutical company, or a CRO.
- Must be flexible travelling domestically up to 40% for study oversight.
- Working knowledge of FDA regulatory requirements and GCP.
- Must have previous monitoring, clinical data review, and clinical trial management experience.
- Strong computer skills including; proficiency in use of Microsoft Word, Excel and PowerPoint.
- Must have experience in Phases I-III of drug development.
- Experience in ophthalmic, oncology, or other therapeutics is highly desired.