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

Medical University of South Carolina • Charleston, SC

2d • Onsite

About The Position

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.

Requirements

• A bachelor's degree and three years relevant program experience.
• Excellent communication and research skills.
• Ability to provide timely responses to inquiries via email, meetings, and other business communication channels.
• Strong computer skills (EPIC, Word, Excel, database software, web-based activities, email).
• Knowledge of MUSC IRB, ORSP, and OCR policies/procedures.
• CCRP certification.
• 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.

Nice To Haves

• A minimum of 1-year relevant Cardiology-Heart Failure disease state knowledge.
• Cardiology disease state knowledge preferred.
• Experience coordinating clinical trials that involve drugs, devices, and procedures is necessary.

Responsibilities

• 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.
• Employee performance management, resource allocation, and professional development of directly supervised team members.
• Training and mentoring new study coordinators and research staff in understanding cardiology terminology and concepts.
• Serving as the point of escalation for research staff and project-related barriers and issues.
• Performing duties independently and exercising judgment in handling a variety of management issues.
• Participating in Site Feasibility Questionnaires and Site Qualification Visits.
• Attending all Site Initiation visits for assigned coordinators and studies within the sub-specialty.
• Coordinating study visits, performing assessments (6-minute walk, vitals, etc.), and processing lab samples for any assigned Cardiology clinical trial.
• 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.
• Managing all regulatory aspects of multiple studies, maintaining study databases, maintaining and completing study documents, and managing drug accountability.
• Ensuring up to date training in each relevant electronic Data Capture System for active clinical trials.
• Liaising and facilitating effective communication between the Principal Investigator (PI), study sponsors, and Clinical Research Associates (CRAs).
• Serving as a liaison to other clinical services and providers within Cardiology outpatient and inpatient clinics, the Cardiology Catheterization lab and other ancillary departments.
• Participating 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.
• Establishing clinical operation standard operating procedures and proper training and quality assurance initiatives.
• Tracking and reporting study performance goals to plan for each study supported.
• Maintaining confidentiality while conveying sensitive employee and financial information.
• Preparing for and participating in Cardiology Team and Division meetings.
• Monitoring and timely completion of billing and compliance objectives for internal and external electronic data sources (ex. OnCore).
• Providing guidance and support to division administrators and faculty regarding budgetary matters, including expense tracking, budget reallocation, and cost-saving opportunities.
• Participating in process improvement projects as needed.
• Performing other duties as assigned by supervisor.

Benefits

• Medical University of South Carolina participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level