Project Manager II - NCCT Study Start-up Navigator

Atrium Health Wake Forest Baptist seeks a Project Manager II to plan, develop, implement, and evaluate multi-center clinical studies or multiple large studies. The role coordinates clinical-site operations, study personnel, data collection and analysis, regulatory compliance, sponsor relationships, and study budgets.

Responsibilities:

• Oversees the operational activities at the clinical site(s) and coordinates the activities of a multi-center study or multiple large studies
• Collaborates with principal investigator(s) in developing plans for research projects and to discuss the interpretation of results. Negotiates protocol changes with funding agency/sponsor
• Assumes major responsibility for the successful and timely completion of the tasks that comprise the implementation and analysis phases of a multi-center study or multiple studies including planning, development, implementation, and evaluation
• Coordinates the hiring of and provides direction to support staff. Plans and coordinates training sessions for project personnel located at the different clinical sites. Oversees recruitment, data collection, and follow-up activities
• Translates planning and design decisions into concrete activities and tasks for project implementation and sets priorities for project implementation
• Evaluates and interprets collected clinical data. Manages the preparation of progress reports and quality control monitoring; participate in the analysis of study data and the writing of scientific papers for publication
• Develops data collection forms, procedural manuals, and other documents required for project implementation and evaluation
• Ensures that all aspects of the following are completed: a. Study is conducted in accordance to the study protocol and contract b. Legal aspects adhere to state and federal regulations and guidelines c. Requirements of the Medical School and the University comply with the conduct of the study d. Technical requirements of the funding agency are met, including auditing requirements
• Conducts site visits to evaluate staff and study activities. Coordinates sponsor audits
• Represents the project to all related community agencies and organizations, serving as the study's liaison, spokesperson, and representative
• Conducts meetings and visits with potential study sponsors to promote WFUHS as a study site
• Attends and participates in national and local meetings related to the planning, operation, and evaluation of the study
• Assists industry representatives (pharmaceutical, device, etc.) in planning and implementing future studies due to extensive knowledge in the specific field of research
• Responsible for developing and monitoring the study budget(s). Compiles and prepares financial progress reports. Tracks payments by sponsors, assuring correct amount received for each participant and testing
• Performs other related duties incidental to the work described herein

Requirements:

• Master's degree in Psychology, Nursing, or Basic Science with two years' relevant administrative and medical experience in research projects or other health-related activities; or, an equivalent combination of education and experience
• One-year experience in a supervisory capacity
• Excellent oral and written communication skills
• Demonstrates knowledge of scientific principles
• Experience in both single- and multi-center studies