Program Manager, Clinical Research

• Program Manager assists in the supervision, coordination and monitoring the work activity of the GREAT study and T4C initiative
• Responsible for the development of program goals and objectives
• Assists in the preparation of the annual operating budgets
• Recommends, evaluates and interprets personnel actions and policies.
• Assists in overseeing the day-to-day operations of the GREAT study including ongoing clinical trials
• Ensures compliance with all federal regulations surrounding the conduct of clinical and translational research including fiscal matters
• Aligns staffing priorities and develops measures for staff productivity
• Trains staff in good clinical practices (GCP)
• Responsible for the development and implementation of SOPS for the program including financial matters and issues that are followed by all stakeholders
• Compiles customized reports on research activity as needed
• Assist in reviewing, monitoring, and reporting on all studies conducted by the T4C initiative

• Assist the staff in the conduct of clinical research trials including screening, recruitment and entering data
• Participate in periodic management meetings to keep the Executive Director informed of problems and concerns
• Assist in the development of cost reduction for projects and targets in collaboration with the Executive Director
• Provide qualified competent staff by tracking projected staffing needs against qualifications competencies of current staff to identify any deficiencies, rectify the deficiencies to improve staffing levels
• Assist the Executive Director in defining the qualifications and performance expectations for all staff positions through the Performance Development system, including department specific job descriptions, measurable performance standards
• Along with the Executive Director, create an environment that encourages and supports self-development and learning for all staff through regular feedback. Ensure that each staff member’s ability is assessed regularly
• Counsel employees with regard to disciplinary actions taken in response to violations of institutional policies, including federal policies, or contractual provisions and discuss such violations with the Executive Director
• Assist in interfacing directly with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.
• Assist in communicating with laboratories or investigators regarding laboratory findings.
• Contacts outside health care providers and communicate with subjects to obtain follow-up information.
• Directs the requisition, collection, labeling, storage, or shipment of specimens.
• Identifies protocol problems, informs investigators of problems, or assists in problem resolution efforts such as protocol revisions.
• Informs patients or caregivers about study aspects and outcomes to be expected.
• Instructs research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures.
• Maintains contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data.
• Orders supplies necessary for study completion.
• Organize space for study equipment and supplies.
• Oversees subject enrollment to ensure that informed consent is properly obtained and documented.
• Collaborates in the development process of study protocols including guidelines for administration or data collection procedures.
• Reviews study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
• Performs other related duties as assigned.

• Ability to manage a complex organization with numerous direct reports
• Knowledge of business and management principles involved in strategic planning, resource allocation, leadership technique, production methods, and coordination of people and resources
• Experience in managing numerous direct reports
• Understanding and implementing the federal regulations that govern clinical research
• Ability to work closely with physicians, nurses and study coordinators

• Experience in initiating and coordinating collaborative and programmatic research across units or disciplines
• Ability to work with a variety of people to ensure their cooperation and input in documenting existing data and programs and in developing additional ones as needed.

• Advanced degree such as MSN or terminal degree such as MD or MBBS or PhD or Equivalent degree is required. In-depth knowledge and firsthand experience of the business principles required to run a clinical research unit, as well as the NIH regulations which govern the operation of the unit, is required.

• Certification as clinical research professional desired.

• RN,

• MSN or terminal degree such as MD or MBBS or PhD
• Certified Clinical Research Coordinator (CCRC)
• Certified Clinical Research Professional (CCRP)
• Certified Clinical Project Manager (CCPM)
• Clinical Trial Manager (CTM)
• Project Management Professional (PMP)

• Usual office environment.
• Manual dexterity
• Visual and auditory acuity
• Able to sit, stand or walk for extended periods of time

Meharry Medical College