UNIV - Program Manager I - Department of Medicine: Division of Cardiology - MUSC

Job Description SummaryThe Program Manager I is responsible for managing the +$4M Clinical Trials Research program within the Division of Cardiology. The Program Manager I is responsible for the management of the program’s processes, services, e...

Job Description Summary

The Program Manager I is responsible for managing the +$4M Clinical Trials Research program within the Division of Cardiology. The Program Manager I is responsible for the management of the program’s processes, services, efforts, compliance and infrastructure to ensure they continually align with the goals and vision of the Division of Cardiology and Department of Medicine. This position will be responsible for managing the research portfolios of multiple principal investigators (PIs) within the Division of Cardiology. This oversight encompasses regulatory and compliance issues, policy and procedure development, and project management and research coordination for the program, including collaboration on the contracting process, budgetary development, and resource allocation. The position requires effective communication and interaction with staff and faculty in the Division of Cardiology, Department of Medicine, and other institutional departments and research personnel, as well as external agencies. Additionally, this position is responsible for the oversight of the direct management of the Clinical Trials program research staff team. Assists in long-range strategic planning for growth of the Clinical Trials program growth, and participates in other Divisional and Departmental research initiatives. This position will perform duties independently and exercise judgement in handling a variety of management issues.

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type​

Research Grant

Cost Center

CC000966 COM DOM Cardiology CC

Pay Rate Type

Salary

Pay Grade

University-07

Pay Range

Scheduled Weekly Hours

40

Work Shift

Job Description

Job Duties:

Program Development and Leadership (30%):

• Responsible for the development of the Clinical Trials Research Program within the Division of Cardiology. Works with the medical director of the Cardiology Clinical Trials Research Program to identify the goals and priorities of the Program.

• Establishes the infrastructure to support successful achievement of the goals. Oversees the flow of research projects through implementation, including first contact with the site, feasibility of the project at the site, completion of the site qualification visit, receipt of regulatory and budget packet, completion of site initiation visit, subject recruitment and study conduct and completion.

• Develops and maintains research procedures for the Programs with the goal of standardization, increased efficiency and ensuring compliance with Institutional guidelines. Manages quality assurance and quality improvement goals and objectives through routine audit review of the program’s portfolio.

• Conduct on-going analysis of Division infrastructure by reviewing workload, staffing, organizational structure, operating procedures, determine priorities, and allocate resources to meet the needs of department research program.

• Identifies and establishes necessary resources, personnel, equipment, and facilities to be utilized by the program.

• Participates in ongoing and upcoming initiatives to grow research division.

Management of Research Staff (25%):

• Provides oversight of the direct management of the Clinical Trial Program’s eight staff members, including hiring and supervision. Provides day‐to‐day coaching and guidance as needed for program staff.

• Defines and oversees the roles and responsibilities of the program staff to ensure adequate coverage. Serve as the point person for all coordinator work related questions, training, study allocations/assignments, oversight, and conflict resolution.

• Develops and maintains plans to allow for cross‐coverage and responsiveness in a highly dynamic research environment.

• Serves as the link between each PI and the management of staff.

• Plans for future staffing needs based on the growth of the Clinical Trials Research Program.

• Assists and train staff in IRB submission and other regulatory actions.

• Develops and manage core competencies for staff. On-going evaluation to assure the scope of each position remains accurate.

• Facilitates educational activities including training of other coordinators in study organization and subject recruitment/retention techniques.

• Working collaboratively with Division leadership, coaches and counsels employees and, when  required, implements the disciplinary process within institutional guidelines.

• Mentors staff to improve ability to participate in team efforts.

PI Research Portfolio Management and Oversight (25%):

• Responsible for managing the life cycle of each research project from start to finish consistent with the priorities and goals for the Clinical Research Programs. Achieve the research goals outlined in research projects by working closely with PIs and the funding agencies.

• Ensures timely and accurate milestones are met regarding processes with the IRB, government agencies, and study sponsors, especially in the areas of study recruitment, study enrollment, adverse effects, study renewals, study determinations, and other activities necessary for exceptional performance of all studies from inception to close.

• Acts as the point of contact for external research project opportunities for the programs, including the IRB, Nexus/CTRC, and the sponsor.

• Completes a feasibility review of potential projects being considered by the PIs and provides feedback on any potential problems.

• Conducts pre‐site selection visit and associated documentation. Receives and processes site selection packages. Sets and manages the timeline for each new project starting within the program.

• Monitors the progress and performance of all research projects on an ongoing basis to include quality of services provided, compliance with regulatory requirements, and adherence to financial targets relative to established timelines and key milestones.

• Provides the Division leadership team with fiscal oversight for all clinical trials activities.

• Responsible for budget oversight and assuring accrued revenues are invoiced and accounted for.

• Ensures delays are identified and communicated to PIs in a timely manner.  Provides regular updates to the PIs and division leadership. Acts as a resource for the investigators in the programs.

• Works with the PI to expand their research footprint by seeking new opportunities. 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.

Regulatory Expertise (15%):

• Oversees all annual and spontaneous internal and external audits of the program. Assesses audit findings and works with the PI, external sponsor, and staff to provide a response.

• Provides leadership and guidance in identifying, implementing, and managing compliance with corrective action plans and processes. Provides oversight for all regulatory submissions to ensure they are organized and completed in a timely manner to the IRB and sponsors including the initial submission, continuing reviews, amendments, protocol deviations, and other reportable events. Identifies regulatory challenges related to the conduct of clinical trials and work flow of the Clinical Research Program.

• 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. 

• Develops, directs, and manages comprehensive research compliance activities and leads overall efforts to include developing policies and procedures related to the monitoring/auditing of research program. Including, but not limited to, development of Corrective Action Plans for improved clinical trial performance and/or compliance

Special Projects (5%):

Perform special projects and/or additional assignments as needed, at the discretion of the Division Director, Division Administrator, or Clinical Trials Program Medical Director.

Additional Job Description

Minimum Requirements: A bachelor's degree and three years relevant program experience.

Physical Requirements: (Note: The following descriptions are applicable to this section: Continuous - 6-8 hours per shift; Frequent - 2-6 hours per shift; Infrequent - 0-2 hours per shift) 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 20/40 vision, corrected, in one eye or with both eyes. (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)

If you like working with energetic enthusiastic individuals, you will enjoy your career with us!

The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need.

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