Clinical Studies Operations Specialist I
2525 Dupont Dr Irvine, CA 92612 US
*Depending on experience
The Clinical Studies/Operations Specialist I will assist the Skincare Clinical Team and Director, Clinical Development Skincare with the operational execution and management of Skincare clinical research studies conducted with CROs and research sites. The Clinical Studies/Operations Specialist I will support all clinical research activities from start-up to close out as needed. The incumbent is responsible for creating study documents, collecting site non-regulatory documents, tracking study budgets, monitoring site activities, and managing data.
• Contributes to the development and preparation of study protocols, informed consent documents, CRFs, subject instructions and all related study materials. Creates and maintains the trial master file for each clinical study.
• Determines the amount of investigational test product needed for each clinical trial and orders/requests from the appropriate team. Projects the clinical supplies required for the conduct of a clinical trial (regulatory binder, laboratory supplies, case report form books, etc). Ship test products and clinical supplies to sites. Manages the study product and supply inventory needs throughout the clinical study and communicates inventory needs to the appropriate clinical project team member or vendor as needed.
• Assists in the management of clinical project budgets and contracts with CROs and clinical sites. Track study milestones and process payments to CROs and clinical sites. Maintains financial files for each clinical project. Submit monthly departmental accruals to Finance.
• Assists in the development of clinical project timelines and performance tracking metrics for all activities needed for the execution of each assigned clinical study. Updates the trial status at regular intervals for reporting to project team members and upper management. Submit clinical studies to the clinical trial registry team and provide study updates and data results for posting on the ClinicalTrials.gov website, as needed.
• Assists in the management of external contract resources and acts as liaison with CROs and vendors. Confirms the qualifications of investigators, medical centers, and research sites throughout the conduct of a clinical trial. Monitors clinical study sites and ensures they are performing the clinical trial according to the study protocol, procedures and the appropriate regulatory agency guidelines. Tracks the day-to-day progress of clinical site activities and provides guidance and support to clinical sites as needed. Perform site visits to audit clinical study records-including source document verification and reviewing clinical supply accountability records, and other study files, as appropriate. Resolve data and proper maintenance of site’s Clinical Trial/Regulatory Binder. Document all findings, outcomes, and agreement reached during site visits.
• Assists in the timely review of post-marketing adverse events and identifies and communicates safety issues and “patterns” to the SkinMedica regulatory/safety review committee.
• Tracks receipt of completed study data, performs data entry and conducts statistical analysis, or assists in the management of a CRO to conduct the statistical analysis. Assists in the review of study data and generates final study results slide deck, final study reports, posters, manuscripts drafts and collateral marketing material.
• Bachelor’s Degree in a scientific field and two or more years of experience in a clinical research position.
• Strong knowledge of Good Clinical Practices and application to the conduct of clinical trials in the United States highly desirable.
• Analytical and problem resolution skills.
• Strong communication skills, both verbal and written.
• Strong interpersonal skills and ability to work well in a matrixed organization; effective collaboration with all constituencies is critical to the success of this position.
• Manage and prioritize work load, multi-task and manage a diverse mix of issues, responsibilities and challenges.
• Function in a controlled/regulated environment and handle restricted, confidential, private and personal information.
• Demonstrated experience in establishing and maintaining effective relationships with management, peers and subordinates and customers.
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