Job Description:

• Participates in the day-to-day supervision of clinical trial execution, with a focus on site start up, patient enrollment, monitoring, and data flow metrics from the clinical sites, CROs and central labs
• Supports complex clinical trial activities in support of the Clinical Study Manager and other team members 
• Prepare study documents (i.e. consent forms, site instructions, study specific materials such as the Manual of Operations, Pharmacy binder, etc.)
• Ensures tracking of essential documents are received and filed in the TMF, reviews site documents for accuracy; provides clinical team support with TMF filing and management
• Ensures tracking of patient status throughout the study at investigative sites
• Tracks and monitors sample collection, central laboratory reporting, and manages laboratory testing schedule
• Assists with laboratory vendor management and liaises with the CRO and clinical trial sites to ensure appropriate sample handling, shipment and result reporting
• Review monitoring trip reports, track data query reports, site visit metrics, and overall site performance
• Attends site initiation, routine monitoring and close-out visits at a limited # of clinical sites, as well as co-monitoring with CRO
• Ensures quality of the data generated from clinical sites and assists in resolving subject eligibility and protocol deviation issues
• Assists in the preparation of, and may present at investigator vendor meetings and workshops
• Actively involved in the performance of study feasibility assessments
• Review of site contracts and budgets for study start-up
• Coordinate the activities from third party vendors including metrics, accruals, process planning, and implementation

Required Skills:

• 3 or more years of industry experience, working in Clinical Operations preferred
• Experience working in a global clinical trial
• Working knowledge in Good Clinical Practices (GCP) regulations and Standard Operating Procedures
• Understanding of study phases and general knowledge of how they apply to clinical development
• Advanced knowledge of Word, Excel, and PowerPoint.
• Knowledge of the principles and practices of computer applications in database management
• Strong verbal and written communication skills.

Education:

• Bachelors’ degree or higher