Clinical Trial Administrator

Christiana Care Health System - Newark, DE (30+ days ago)4.1

The Office of Sponsored Programs (OSP), is currently searching for a Clinical Trial Administrator, for their Clinical Trials Division. In this role, you will develop, coordinate and implement all operational processes within. This includes, but is not limited to clinical trials pre-award project oversight, and quality assurance.

PRINCIPAL DUTIES AND RESPONSIBILITIES : Develops, coordinates and implements all operational processes within the Office of Sponsored Programs Clinical Trial Division. This includes, but is not limited to: clinical trials pre-award and post-award project oversight, internal approval/signature process and quality assurance. Maintains the overall accuracy of the institution's clinical trials portfolio within the organization's Sponsored Programs) Access Database. Acts as an institutional liaison between Data Doctor Office Technology Systems (DDOTS), Inc. and Christiana Care. Maintains and trains CCHS research departments on the DDOTS -CREDIT system. Provides support for system changes such as upgrades, expansions and trouble-shooting of the system. Conducts ongoing education with the CCHS research departments as required. Develops and maintains a cost analysis computer program to allow appropriate finance tracking while ensuring compliance with CIA requirements. Reviews industry-sponsored clinical trials and source documents to provide guidance to research departments and staff regarding cost and feasibility of clinical trial participation. Develops project budgets and contract/compliance issues related to clinical trials and negotiates the budget with the industry sponsor Meets individually with project managers to conduct budget feasibility assessments after thorough review of all industry-sponsored protocols. Works with project managers/directors to develop study budget, including per patient costs, service provider costs, etc… Negotiates and processes all Confidentiality Disclosure Agreements (CDA's) and other agreements with industry sponsored projects. Serves as the direct point-of-contact for all clinical trial research departmental issues and resolves issues either directly or indirectly. Acts as a liaison between the Office of Sponsored Programs Clinical Trial Division, the research community, Legal department and the Institutional Review Board (IRB). Collaborates with the Research Education and Compliance Manager to coordinate training sessions to the Research Enterprise.Develops education and focuses on areas that directly affect clinical trial management. Performs assigned work safely, adhering to established departmental safety rules and practices; reports to supervisor, in a timely manner, any unsafe activities, conditions, hazards, or safety violations that may cause injury to oneself, other employees, patients and visitors. Performs other related duties as required.
EDUCATION AND EXPERIENCE REQUIREMENTS: Bachelor's Degree in Business or Finance preferred. Three years' experience in sponsored programs administration preferred. Two years of Grant/Finance experience required. Experienced in clinical trials and budgeting An equivalent combination of education and experience may be substituted.

Christiana Hospital, Newark, Delaware. This 1,007-bed, 1.3-million-square-foot modern facility provides a level of care only available in large-scale teaching hospitals. Christiana Hospital includes Delaware's only Level-I Trauma center (as verified by the American College of Surgeons), which is prepared to handle the most extreme medical emergencies. In fact, it is the only Level-I Trauma center on the East Coast corridor between Baltimore and Philadelphia. Christiana Hospital has also been nationally recognized in U.S. News and World Report's Best Regional Hospitals rankings as #1 in Delaware and #3 in the Philadelphia metro area, plus High Performing in 9 Adult Procedures/Conditions. Academic medical center, Baltimore area, Best regional hospital, Community-based medicine, Community health, Clinician, Delaware hospital, Delaware's largest health system, Electronic medical records, Epic EMRs, Everest Award-winner, In-patient, Level I Trauma Center, Magnet® designation, Nationally recognized, Outpatient, Philadelphia area, Provider, Surgery center, Teaching hospital, Wellness, Wilmington, Newark, U.S. New & World Report ranking, Expert, Serve, Care, Healthcare, Respectful, Dover, Bear, Middletown, Rehoboth Beach, Bethany Beach, Delmarva Peninsula, New Castle, Elkton, Maryland, Glasgow, Hockessin, Brookside, Smyrna, Pike Creek Valley, Milford, Claymont, Pike Creek, Wilmington Manor, North Star, Seaford, Southeastern Pennsylvania, Southern New Jersey, Vineland, Millville, West Chester, Kennett Square, Swedesboro, Carneys Point, Woodstown, Salem, Elmer, Deptford Township, Washington Township, Pitman, Glassboro, Franklin