* Facilitates all operational activities pertaining to the execution of clinical trials
* Serves as primary contact for functional area representatives and is responsible as the primary contact with CROs in managing protocol execution
* Maintains regular internal contact with relevant departments such as Clinical Development, Clinical Science, Clinical Supplies, Regulatory Affairs, Drug Safety and others as necessary
* Responsible for the day-to-day interaction with multiple CROs in the execution of ongoing clinical trials
* May manage the overall activities of CROs, central laboratory, and drug distribution center
* Regularly assists in the creation and review of study protocols, informed consents, case report forms, clinical study reports, study materials and monitoring tools.
* Establishes study milestones and ensures accurate tracking and reporting of study metrics
* Ensures accuracy and timeliness of vendor and site payments, through invoice review and approval
* Prepares and tracks required documentation from clinical sites.
* May participate in reviews and resolution of discrepancies in clinical data with responsible CROs and clinical sites
* Reviews monitoring reports, study invoices (Vendor, Site), tracks study progress, provides updates to Managers, Clinical Operations and maintains study files
* Provides input for definition of new or revised process development, problem solving, training, etc., as needed
* Travel may be required in the United States up to 20% in support of CRO activities
EDUCATION: BS/BA/RN degree in related discipline and three years of related experience; or,
MS/MA degree in related discipline and one year of related experience.
* Requires a minimum of four years of related experience * Knowledgeable in GCP requirements and their application to the conduct of clinical studies in the United States * Experience developing trial plans including, site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management * Oncology therapeutic area knowledge strongly preferred * Strong oral and written communication skills
To find out more about Real please visit www.realstaffing.com
Real - 14 months ago