Manage the development, coordination and implementation of the U.S. POINTER clinical trial. This position is responsible for trial specific processes and systems, and the daily supervision of the clinical operations team. Work within the matrix of the clinical research system to complete all regulatory applications.
Summary of U.S. POINTER Clinical Trial:
The U.S. Study to Protect Brain Health through Lifestyle Intervention to Reduce Risk (referred to as “U.S. POINTER”) is a large national randomized controlled trial funded by the Alzheimer’s Association that will test whether lifestyle modification can protect cognitive function in older cognitively normal Americans who are at increased risk for cognitive decline and Alzheimer’s disease. The trial will be coordinated by a team at Wake Forest School of Medicine and five sites across the U.S. will each enroll 400 participants into the study. The U.S. POINTER lifestyle intervention will be delivered in the community, by community partners to facilitate development of a sustainable brain health program that could continue long after the study is completed if the results are positive. U.S. POINTER has the potential to provide scientific confirmation that a non-pharmacological intervention that involves diet, exercise, and management of cardiovascular risk factors can possibly prevent Alzheimer’s disease.
U.S. POINTER Principal Investigator and other lead investigators of the U.S. POINTER Coordinating Center.
Scope of Work:
Responsible for the successful implementation and evaluation of programs and initiatives to support the Administrative and Clinical Operations Coordinating Center (ACOCC) for the U.S. POINTER clinical trial. Works closely with the U.S. POINTER Leadership to develop communications, to disseminate information, and to administer the program. Monitors project budgets, collects and analyzes data to evaluate the effectiveness of the programs in meeting key objectives, assesses the impact of the programs on important outcomes, and develops reports summarizing program activities. Classification requires judgment and discretion in performing the assigned duties and responsibilities related to the trial, and supervisory experience.
Manage and serve as an expert resource for all aspects of the ACOCC for the U.S. POINTER trial.
Assume major responsibility for the successful and timely completion of tasks that comprise the development, implementation, and evaluation of protocols and procedures for U.S. POINTER.
Work with sponsors and other ancillary study Principal Investigators to develop an adequate budget, ensuring that ACOCC is being compensated adequately for all clinical-related procedures. Once budget has been negotiated, work within the Wake Forest University system to facilitate the submission of budget and contract to the appropriate departments.
Coordinate the hiring of and provide direction to support staff; plan and coordinate training sessions for project personnel located at the different clinical sites.
Translate planning and design decisions into concrete activities and tasks to be undertaken for project implementation, and set priorities for project implementation.
Develop data collection forms, procedural manuals, and other documents required for project implementation and evaluation.
Oversee recruitment, data collection, and follow-up activities.
Direct the development of methods for monitoring and reporting on the study.
Oversee the submission of the study to the Institutional Review Board at Wake Forest University, which will act as the central IRB for U.S. POINTER. Work with both the sponsor and the IRB to address all concerns and get the study operational in a timely manner.
Conduct site visits to evaluate staff and study activities. Coordinate sponsor audits.
Attend and participate in national and local meetings related to the planning, operation, and evaluation of the study; participate in study committee and executive leadership meetings.
Manage the preparation of progress reports and quality control monitoring.
Oversee and monitor program budgets.
Serve as a study liaison and spokesperson, representing the project to all participating community agencies and organizations.
Ensure that all aspects of the study are conducted in accordance with the study protocol and contract; ensure that all legal aspects adhere to state and federal regulations and guidelines.
Ensure that all requirements of the Medical School and the University are followed relative to the conduct of the study; ensure that all technical requirements of the funding agency are met, including auditing requirements.
Regularly review the scientific literature to keep abreast of new developments related to U.S. POINTER scientific aims.
Perform other related duties incidental to the work as assigned by U.S. POINTER leadership.
Work performed in an indoor, clinical research setting
May be exposed to infectious and contagious disease
May be exposed to body fluids
May be exposed to radiation hazards
May have contact with study participants under a wide variety of circumstances
Master's degree in a relevant discipline such as psychology, nursing, or another related field of science (e.g., education, public health, biological sciences or another relevant clinical discipline).
Three years of relevant management experience or an equivalent combination of education and experience.
Familiarity with institutional and governmental regulations and guidelines related to clinical research including the elements of Good Clinical Practices.
Demonstrated knowledge of scientific and statistical principles.
Ability to travel to affiliate sites, clinical sites and national meetings.
Excellent verbal and written communication skills.
Additional Desirable Experience:
A minimum of two years of relevant clinical research experience, or an equivalent combination of education and experience.
A minimum of two years of supervisory experience.
Experience working with older adults
Interest and experience related to overall health and lifestyle (e.g., nutrition, physical activity, cognitive health
Skills and Qualifications:
Ability to prioritize and organize a high volume workload and changing priorities
Familiar with principles of protocol development, study design, statistics, and regulatory processes
Ability to direct the work of others
Facility with multiple software document and data management programs (Word, EXCEL, Outlook, PowerPoint, Adobe)
Ability to analyze financial information
Ability to maintain research participant confidentiality and comply with HIPAA regulations
About Wake Forest Baptist Medical Center
Wake Forest Baptist Medical Center is a nationally recognized academic medical center and health system based in Winston-Salem, NC.
The institution comprises Wake Forest School of Medicine, a leading center for medical education and research; Wake Forest Baptist Health, the integrated clinical structure; and Wake Forest Innovations, which promotes the commercialization of research discoveries. Clinical facilities include North Carolina Baptist Hospital, Brenner Children’s Hospital, and a network of affiliated community hospitals, physician practices, outpatient services and other medical facilities.
The Medical Center has been ranked as one of “America’s Best Hospitals” by U.S. News & World Report since 1993. It holds the coveted Gold Seal of Approval from The Joint Commission and has achieved Magnet status, the nation’s highest nursing recognition.
Becker’s Hospital Review in 2014 named Wake Forest Baptist Medical Center to its annual list of “100 Great Hospitals in America.’’ The Becker’s list represents “a compilation of some of the most prominent, forward-thinking and focused health care facilities in the nation.” Wake Forest Baptist was specifically cited for its qual...ity and safety measures. Wake Forest Baptist Medical Center has received a Consumer Choice Award as the top-rated hospital in the Winston-Salem area every year since 1999.