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

The Division of Cardiology is seeking a Program Manager I to lead clinical research activities within its comprehensive Heart Failure program. In this role, the Project Manager I will supervise a dedicated research team including clinical research coordinators and research assistants. This position will also manage the execution of complex clinical trials to ensure high-quality study coordination and support. Excellent communication and research skills are necessary for this position.

This position will need to provide timely responses to inquiries via email, meetings, and other business communication channels. This position will report to the Nurse Manager II who oversees all clinical trials personnel within the Division of Cardiology.

Medical University of South Carolina (MUSC - Univ)

Employee

Research Grant

CC000966 COM DOM CARD General CC

Salary

University-GEN
11

66,400.

-

40

• Responsible forthe direct supervision of Cardiology Clinical Research staff (program coordinators, research assistants, etc.) that support clinical trials within the Heart Failure program.
• Responsible forthe 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.

• Responsible for coordinating study visits, performing assessments (6-minute walk, vitals, etc.), and processing lab samples for any assigned Cardiology clinical trial.
• 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.
• Accountable forall regulatory aspects of multiple studies,maintainingstudy databases, maintaining and completing study documents, and managing 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 Catheterizationlaband other ancillary departments.
• Participate in the feasibility review process by reviewing protocols anddeterminingthestudypatient 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.

• 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.

• 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.

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

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.