Clinical Research Manager Registered Nurse

Sanford Health is an integrated health system headquartered in the Dakotas. It is one of the largest health systems in the nation with 43 hospitals and nearly 250 clinics in nine states and three countries.

Provides daily leadership for clinical aspects in the conduct of clinical trials, grants and industry sponsored, and ensures adherence to state, federal, and international regulations. Gathers information, selects the best strategy, implements and evaluates decisions to assure continuous improvement and contribution to the goals of Clinical Research.

* Oversees the process and selection of clinical trials, reviews, and determines viability and financial feasibility of the clinical trial at our site. * Oversees the data management for clinical trial patients by distributing queries, monitors overdue materials and follows up on any outstanding data inquires for grant and other reporting requirements and for patient identification purposes. * Oversees and participates in the set up of clinical trials to include budget, determination of conventional care versus non conventional care and coordinating funding of those non-conventional care items, interdepartmental communications, and identifying potential clinical or patient related issues and solutions for the CRA/CRC staff. Coordinates with the research Financial Supervisor to set up payment calendars and projection of accruals. * Performs weekly and monthly status reporting to the principal investigators and prepares monthly status reports for the Director of Operations. * Clearly communicates any safety issues identified in specific clinical trials to the CRA/CRC staff and physicians providing guidance on informing patients as required. Oversees the timely and accurate reporting of Serious Adverse Events and Clinical Trial Deviations as they occur. * Oversees and participates in the site selection visits, site initiation visits and ongoing regulatory processes for new and open clinical trials. * Maintains a current understanding of CMS and insurance laws as they apply to research patients while overseeing the pre-approval process. * Acts as a liaison between the pharmaceutical or device sponsors and the site. Maintains and promotes effective communication with the Institutional Review Board. * Educates physicians on principal investigator and sub-investigator requirements and responsibilities. Coordinates, monitors and evaluates the training needs of research staff including human protections, GCP, CPR, and other training as needed.

* Bachelor's degree in Nursing required; Master's degree in healthcare, business or science related field is preferred. * Must have three years related research experience. * Management experience preferred. * Must have knowledge in nursing principles applied in research setting, nursing management, regulatory procedures, data management, statistical analysis principles, and research billing procedures. * Excellent communication, team building, and leadership skills required. * Must hold current registered nurse license in state(s) of practice and/or possess multi-state licensure priveleges as required by position.