Medical University of South Carolina UNIV - Program Manager - Department of Medicine: Cardiology in Charleston, South Carolina
Job Summary: Supervise the clinical trials research staff in their daily activities and assign projects as appropriate. Will direct, submit and maintain records of regulatory paperwork related to our research projects and maintain communication with the Institutional Review Board, the NIH, and the Clinical and Translational Research Center, Principal Investigators and industry sponsors. Will direct and assist in subject recruitment, study procedures and will assure compliance with staff and study subjects. Will assist in preparing materials to report research progress back to the PIs and the Department of Medicine Smart Team and assure proper accruals for reimbursement for study expenses. Determines appropriateness of trial opportunity by conducting a feasibility analysis involving multiple PIs. Assist and train staff in IRB submission and other regulatory actions. Develops data management plan.
Payscale Salary Range: UNIV-Band 7: $49,594.00 - $70,674.00 - $91,755.00 (min - mid - max)
35% - Supervise all clinical research nurses and program coordinators. Serve as the point person for all coordinator work related questions, training, study allocations/assignments, oversight, and conflict resolution. Facilitate educational activities including training of other coordinators in study organization and subject recruitment/retention techniques. Oversee all issues related to study compliance. Responsible for budget oversight and assuring accrued revenues are invoiced and accounted for. Oversees internal and external audits, manages multiple study portfolio and mentors clinical research team. - (Essential)
35% - Responsible for the startup and the continuation of studies & coordinate clinical research projects with staff and PIs. Work with clinicians, RNs, Program Coordinators and other members of the patientcare team to identify strategies to recruit study participants’ in compliance with study requirements and protocol. Travel to participating physician offices to publicize and explain the study to potential enrolling sites to maximize enrollment. Will assist in preparing materials to report research progress back to the Program Director and PIs. Conducts feasibility analysis and determines appropriateness of trial opportunity to include preparatory to research patient pre-screenings. - (Essential)
20% - Serve as the primary contact for the IRB, Nexus/CTRC, and the sponsor. Assist in the preparation of study budgets reports, and relay study related information to the PIs. Submit and maintain records of regulatory paperwork to establish and maintain cardiac clinical research studies, ensuring that compliance of federal and institutional guidelines for human research are met. Provides training to other staff on informed consent process and HIPAA. Identifies, completes and submit required supplemental regulatory docs promptly. - (Essential)
5% - Coordinate the establishment and organization of new clinical trials, in concert with the Department of Medicine Smart Team determine study expenses and prices for budget negotiations, sponsor site visits to MUSC, travel to investigator meetings as needed, and provide sponsor or CRO information required to establish a study site at MUSC. - (Essential)
5% - Assist and train staff in IRB submission and other regulatory actions. Develops data management plan. - (Essential)
Minimum Experience and Training Requirements: A bachelor's degree and three years relevant program experience.
Physical Requirements: Ability to perform job functions in an upright position. (Frequent) Ability to perform job functions in a seated position. (Frequent) Ability to perform job functions while walking/mobile. (Frequent) Ability to work indoors. (Continuous) Ability to work outdoors in all weather and temperature extremes. (Infrequent) Ability to work in confined/cramped spaces. (Infrequent) Ability to perform job functions from kneeling positions. (Infrequent) Ability to squat and perform job functions. (Infrequent) Ability to perform 'pinching' operations. (Infrequent) Ability to fully use both hands/arms. (Frequent) Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent) Ability to reach in all directions. (Frequent) Possess good finger dexterity. (Continuous) Ability to maintain tactile sensory functions. (Continuous) Ability to lift and carry 15 lbs., unassisted. (Infrequent) Ability to lift objects, up to 15 lbs., from floor level to height of 36 inches, unassisted. (Infrequent) Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent) Ability to maintain 20/20 vision, corrected. (Continuous) Ability to see and recognize objects close at hand. (Frequent) Ability to see and recognize objects at a distance. (Frequent) Ability to match or discriminate between colors. (Frequent) Ability to determine distance/relationship between objects; depth perception. (Frequent) Good peripheral vision capabilities. (Continuous) Ability to maintain hearing acuity, with correction. (Continuous) Ability to hear and/or understand whispered conversations at a distance of 3 feet. (Frequent) Ability to perform gross motor functions with frequent fine motor movements. (Frequent) Ability to work in dusty areas. (Infrequent)