Study Manager / Sr. CRA
5000 Hopyard Road, Suite 402 Pleasanton, CA 94588
Bayside Solutions is seeking a Study Manager / Sr. CRA to be part of our client’ s team in the East Bay. The Study Manager / Sr. CRA works with clinical project team members, vendors, and CRO teams to assure that protocol requirements, regulatory guidelines and study timelines are defined and met. This position will be reporting to the AD, Clinical Operations and work in partnership to report monitoring metrics and related site critical issues.
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.
Study Manager / Sr. CRA
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- 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, and 401K.
Summary of Responsibilities:
- Ensures the trials are conducted in compliance with the protocol, SOPs/Work Instructions, ICH-GCP, and applicable regulatory requirements.
- Effectively tracks, files and archives study communications, contracts, and essential documents, to provide a complete TMF and Sponsor records.
- Collates and maintains study metrics for reporting purposes through established clinical study dashboards and trackers; with archiving of reports.
- Provides oversight of vendors/CROs, including invoice processing.
- Reviews monitoring trip reports and follow-up of action items to resolution.
- Prepare and develop materials related to the training and presentations for CRA training, SIVs and Investigator Meetings.
- Develops Clinical Monitoring Plans and reviews/develops monitoring tools.
- In conjunction with Clinical Development/Operations leadership and vendor, develops and tests EDC, IXRS, data analytics and TMF functionality.
- Facilitates CRO CRA project meetings as necessary.
- Provides a key role in problem solving and issue escalation, regarding monitoring issues, with proposed solutions to the CPM or designee, CRO Lead CRA and Director of Clinical Operations.
- Participate in site visits as needed.
Summary of Qualifications:
- BSc/MSc/RN with 7+ years’ experience as a CRA with 3+ years’ experience managing studies and vendors/CROs.
- Prior experience supporting phases I-III clinical trials.
- Experience with multiple therapeutic indications with the ability to learn new indications is highly desired.
- Excellent interpersonal and communication skills
- Prior experience working in a small company or start-up environment is a plus.
- Strong experience with Microsoft Office Suite, including MS Project, MS Publisher, and MS Windows NT.
- Willingness and ability to travel if needed on occasion.
- Demonstrated willingness to be hands-on and perform tasks within tight turnaround time
- Strives to create a dynamic environment, opens to suggestions and experimentation for improvement