Sr. Clinical Trial Assistant - Bay Area

Position Summary:

The Senior Clinical Trial Associate (SCTA) acts as a central contact for the designated clinical study team and in this key support role supports the team in the planning, implementation, and completion of clinical studies both outsourced or in-house, through interaction with investigative sites, vendors, and team members. The SCTA, under the direction and guidance of team members will work independently but knows when to involve and or collaborate with other functional members in the execution of role & responsibilities. Job Responsibilities:

• Obtains, reviews, processes, and tracks study related documents (CVs, FDA 1572s, lab certifications, IRB approvals, contracts, protocols, etc.)
• Sets-up and maintains/ closes out the Trial Master File (TMF/eTMF), perform QC as assigned and resolves discrepancies. - Maintain and update study metrics as necessary, including, but not limited to: Visit Reports, Regulatory Documents, site and team contact lists, vendor lists, etc. - Facilitate with the preparation of agendas and takes comprehensive minutes for internal and external meetings. - Accountable for study level tracking as assigned, e.g. monitor visit tracking, sample tracking, study related supplies etc. - Assists in preparing materials for investigator meetings, monitor workshops, and study manual. - Communicates and coordinates with team members to ensure accurate and comprehensive completion of documents by Regulatory Affairs; makes sure that completed documents are handed over to RA within the requested timeframes and ahead of submission deadlines. - Interfaces with other cross functional groups to coordinate relevant and timely exchange of information / materials as assigned. - Assist with data reconciliation, as required. - Participate in the review of clinical data in the clinical database, data listings, and reports, as assigned. - Update and maintain public clinical trial listings/postings (e.g., www.clinicaltrials.gov, EUDract registry, etc.). - Assist with clinical trial insurance policies (includes obtaining and reviewing policies for new studies, tracking and renewing expiring insurance certificates, etc.). - Prioritizes and plans work activities; Uses time efficiently to meet deadlines. - May be assigned additional responsibilities based on study needs. Qualifications: