UNIV - Program Manager I – Clinical Trials, Heart Failure - Department of Medicine: Division of Cardiology

Job Duties

• Supervision and Management of Research Staff: Responsible for the direct supervision of Cardiology Clinical Research staff (program coordinators, research assistants, etc.) that support clinical trials within the Heart Failure program.
• Management of the Cardiology Division’s trial processes, services, efforts, and compliance to ensure they continually align with the goals and vision of the Division and Department.
• Accountable for employee performance management, resource allocation, and professional development of directly supervised team members.
• Serve a key role in helping train and mentor new study coordinators and research staff in understanding cardiology terminology and concepts.
• Perform duties independently and exercise judgement in handling a variety of management issues.
• Participate in Site Feasibility Questionnaires and Site Qualification Visits. Attend all Site Initiation visits for assigned coordinators and studies within the sub-specialty.

Study Management

• Coordinate study visits, perform assessments (6-minute walk, vitals, etc.), and process lab samples for any assigned Cardiology clinical trial.
• Ensure adherence to study guidelines, manage the subject recruitment and informed consent process, provide education to patients and their families, and serve as the primary point of contact for study subjects.
• Accountable for all regulatory aspects of multiple studies, maintain study databases, maintain and complete study documents, and manage drug accountability.
• Participate in and ensure up to date training in each relevant electronic Data Capture System for active clinical trials.
• Liaise and facilitate effective communication between the Principal Investigator (PI), study sponsors, and Clinical Research Associates (CRAs).
• Serve as a liaison to other clinical services and providers within Cardiology outpatient and inpatient clinics, the Cardiology Catheterization lab and other ancillary departments.
• Participate in the feasibility review process by reviewing protocols and determining the study patient visit flow and provision of center resources to promote protocol compliance and study participant retention.
• Responsible for the establishment of clinical operation standard operating procedures and proper training and quality assurance initiatives.

Project Management

• Track and report study performance goals to plan for each study supported.
• Maintain confidentiality while conveying sensitive employee and financial information.
• Prepare for and participate in Cardiology Team and Division meetings.

Budget Management

• Monitor and timely completion of billing and compliance objectives for internal and external electronic data sources (ex. OnCore).
• Provide guidance and support to division administrators and faculty regarding budgetary matters, including expense tracking, budget reallocation, and cost-saving opportunities.

General Administrative Support

• Participate in process improvement projects as needed.
• Participate in other duties as assigned by supervisor.

Work Schedule

Monday-Friday. A willingness to work flexible hours is necessary; some weekend and evening work will be required. Remote work may be approved after 12 months of University employment and in accordance with the remote work enterprise policy.

Preferred Experience, Knowledge And Skills

• A minimum of 1-year relevant Cardiology-Heart Failure disease state knowledge.
• Strong computer skills (EPIC, Word, Excel, database software, web-based activities, email).
• Knowledge of MUSC IRB, ORSP, and OCR policies/procedures is necessary.
• Required certifications include CITI certifications in BioMedical Research and Good Clinical Practice (GCP), CCRP certification, and shipping hazardous materials.
• Cardiology disease state knowledge preferred.
• Experience coordinating clinical trials that involve drugs, devices, and procedures is necessary.
• This individual must be knowledgeable of Food and Drug Administration federal regulations, local regulatory agency policies, and international Good Clinical Practice.
• The position requires excellent time management, effective communication skills, and the ability to work independently.
• Demonstrated ability to prioritize tasks, meet deadlines, and work independently in a fast-paced environment.

Minimum Requirements

• A bachelor's degree and three years relevant program experience.

Physical Requirements

• Ability to perform job functions in an upright position.
• Ability to perform job functions in a seated position.
• Ability to perform job functions while walking/mobile.
• Ability to work indoors.
• Ability to work outdoors in all weather and temperature extremes.
• Ability to work in confined/cramped spaces.
• Ability to perform job functions from kneeling positions.
• Ability to squat and perform job functions.
• Ability to perform 'pinching' operations.
• Ability to fully use both hands/arms.
• Ability to perform repetitive motions with hands/wrists/elbows and shoulders.
• Ability to reach in all directions.
• Possess good finger dexterity.
• Ability to maintain tactile sensory functions.
• Ability to lift and carry 15 lbs., unassisted.
• Ability to lift objects, up to 15 lbs., from floor level to height of 36 inches, unassisted.
• Ability to push/pull objects, up to 15 lbs., unassisted.
• Ability to maintain 20/40 vision, corrected, in one eye or with both eyes.
• Ability to see and recognize objects close at hand.
• Ability to see and recognize objects at a distance.
• Ability to match or discriminate between colors.
• Ability to determine distance/relationship between objects; depth perception.
• Good peripheral vision capabilities.
• Ability to maintain hearing acuity, with correction.
• Ability to hear and/or understand whispered conversations at a distance of 3 feet.
• Ability to perform gross motor functions with frequent fine motor movements.
• Ability to work in dusty areas.