UNIV - Program Manager I – EP, Structural & Preventative Cardiology Clinical Trials - Department of Medicine: Division of Cardiology

About the role

The Division of Cardiology is seeking a Program Manager I to lead clinical research activities within its comprehensive Electrophysiology, Structural, Interventional, and preventative Cardiology programs.

Responsibilities

• 35% - 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. Responsible for the 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. Serve as the point of escalation for research staff and project-related barriers and issues. 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.
• 35% - Study Management: Participate in Site Feasibility Questionnaires and Site Qualification Visits. Attend all Site Initiation visits for assigned coordinators and studies within the sub-specialty. Responsible for ensuring adherence to study guidelines, managing the subject recruitment and informed consent process, providing education to patients and their families, and serving as the primary point of contact for study subjects. 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.
• 10% - 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.
• 10% - Budget Management: Responsible for monitoring 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.
• 10% - General Administrative Support: Participate in process improvement projects as needed. Participate in other duties as assigned by supervisor

Requirements

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

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.
• 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.