Project Manager, Department of Health and Exercise Science

Wake Forest University•Winston-Salem, NC

About The Position

Working under direct supervision of the study Principal Investigator, the Research Project Manager plans, implements, and monitors the conduct of externally funded human subjects research studies. This position serves as the lead operations manager for research involving the delivery of a physical activity and healthy eating program to manage chronic pain; the Project Manager exercises broad discretion in ensuring research protocols are conducted in accordance with the funded scope of work and in compliance with sponsor, federal, and institutional regulations, policies, and procedures. This position requires a high degree of organizational competence, excellent communication skills, knowledge of human subjects clinical research, and the ability to lead in a dynamic team environment.

Requirements

Master’s degree, preferably in Health and Exercise Science, Exercise Physiology, or similar; other STEM-related degrees will be considered
Broad familiarity with all facets of human subjects research including human subjects protections, clinical research conduct, good clinical practice (GCP) guidelines, and research compliance
Excellent organizational, communication, and management skills

Nice To Haves

Experience in human subjects research as a research assistant, interventionist, project coordinator/manager, or related; salary to be commensurate with prior experience and responsibilities
Experience and/or training in research databases
Experience working with older adults in research settings

Responsibilities

Collaborates with study Principal Investigator to operationalize human subjects research protocols, initiate study activities in accordance with timelines, and monitor study progress
Serves as study operations manager and oversees day-to-day implementation of intervention and data collection protocols
As authorized proxy of Principal Investigator, communicates with Institutional Review Board (IRB), submits IRB protocols and protocol amendments, maintains IRB approvals and other IRB correspondence, and corresponds with performance sites at other institutions regarding IRB matters
Communicates with Wake Forest University Health Sciences (WFUHS) personnel across multiple departments to facilitate implementation and monitoring of study protocols requiring WFUHS resources
Collaborates with study Principal Investigator and biostatistics personnel to assist in and guide development of data entry procedures and protocols (e.g. manual data entry, electronic data capture, etc.)
Develops and implements study marketing plan, formulates advertising matrix based on study budget, monitors participant yields and progress throughout the study, and revises/updates marketing plan as needed to ensure study participant enrollment goals are attained
Assists Principal Investigator and biostatistics personnel with development and implementation of clinical performance site certification process to ensure standardization of procedures across study sites
Bears responsibility for compiling, distributing, and updating study manual of operations (MOP)
Bears responsibility for development and delivery of training for personnel
Compiles materials for sponsor progress reports, NIH just-in-time requests, carry-forward requests, etc.; utilizes sponsor and governmental web platforms to enter data and upload documents for reports and requests
Oversees the participation status and progress of, and safety/adverse events reporting for, study participants; compiles materials for and participates in Data and Safety Monitoring Board (DSMB) meetings
Plans investigators’ meetings, ancillary committee meetings, etc. (onsite and via online web conferencing platforms) and participates in meetings as applicable as the lead operations staff member)
Conducts participant randomization and communicates with participants regarding study arm assignment in accordance with protocol / procedure
Conducts participant recruitment/screening, assessment/testing, and/or intervention delivery activities, as needed, in absence of other research staff
Collaborates with department Grants and Contracts Manager as needed to ensure compliance with institutional policy/procedure regarding procurement actions, negotiation and execution of contracts, payment processing, research-related travel, etc.
Collaborates with department Facilities Coordinator as needed to ensure access to and scheduling of department resources (e.g. laboratories, Clinical Research Center, etc.) required to conduct study
Travels to clinical performance sites at other institutions, as needed, to conduct site certifications, staff training, or other study-related activities
Collaborates with study interventionist to facilitate technology acquisition, setup, and delivery