6000 Shoreline Court Suite 304 South San Francisco, CA 94080
Management of investigational product and study supplies by preparing and ensuring the accuracy of shipments of study-related materials. Which includes, shipment and accountability, using IVRS/IWRS.
• Prepare, review and submit ICF and protocol amendments to IRB.
• Liaise with IRB to coordinate approval of roll over sites into long term safety trial.
• Review regulatory document packets from trial sites for completeness, accuracy and compliance with protocol and appropriate regulations.
• Collaborate with investigator sites and CROs/CRAs/vendors to clarify requisition, request information and gather documents.
• Enter and update protocols on clinicaltrials.gov.
• Prepare and issue Non-Disclosure Agreements and feasibility questionnaires to sites.
• Responsible for reviewing meeting minutes and recording action items.
• Create and maintain trackers for study start up activities, which includes, non-drug and investigational drug supply across studies.
• Reconcile and compile screening and enrollment activity across multiple trials.
• Vendor management.
• Support Clinical Program Leads with scheduling and hosting WebEx investigator meetings, trainings and refresher investigator meetings.
• Set-up and maintenance of Study Trial Master Files (TMFs) and Trial Working Files (TWFs), ensuring all relevant study records are filed and archived with good documentation practices in compliance with regulatory requirements and Standard Operating Procedures (SOPs).
• Maintains and ensures TMF and TWF documentation is in a state of audit-readiness.
• Review several documents in a short time frame while maintaining consistency and attention to detail.
• Maintaining knowledge on ICH-GCP and current company SOPs.
• Ensure essential documents are current, maintained and filed ongoing during study execution. Identify any issues and alert CTM; take appropriate corrective action.
• Close out TMFs; after study is completed, perform final quality control checks of TMFs, collect outstanding documents, and archive. Update the archival inventory.
• Receive on-the-job training for any task not previously conducted, and to advance skills (e.g., Word, Excel, QUMAS). For experienced COA, function as a Subject Matter Expert, as assigned.
• Assist in creating, tracking and managing department training plan and matrix.
• Supports clinical and medical team in audit and inspection ready.
• Required experience with TMF/clinical study file documentation oversight and QC, Good Documentation Practice, GCP/ICH and strong understanding of the impact of the TMF on Trial Management
• Previous related experience in support of clinical trials preferred but not required
• BA/BS degree in life sciences or a related discipline with minimum 1yr clinical research experience, or AS degree in science with 2yrs work experience in a similar field or equivalent experience