Program Manager, Clinical Research

This position is responsible for assisting in the day-to-day operations of the GREAT study and Together for Change (T4C) Initiative and the strategic planning for the position is reporting to the Executive Director of the Center of Excellence of Clinical and Translational Research. The position will also assist in supervising the clinical research coordinators and clinical research assistants working with the initiative.

Essential Functions:

• 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.

                                                                                                                             

Knowledge, Skills and Abilities:

• 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

 Knowledge, Skills, Abilities Preferred

• 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.

Education and Experience Required:

• 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.

Education and Experience Preferred:

• Certification as clinical research professional desired. 

Licensure, Certification or Registration Required:

• RN, Clinical Research Coordinator (CRC),

Licensure, Certification or Registration Preferred:

• 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)

Environmental Conditions and Physical Demands

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