Project Manager, Department of Health and Exercise Science

External Applicants: 

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Job Description Summary

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.

Job Description

This position is not eligible for sponsorship of non-immigrant or immigrant visa status through Wake Forest University. All eligible applicants are encouraged to apply.

Essential Functions:

• 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)

Other Functions:

• 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

Required Education, Knowledge, Skills, Abilities:

• 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

Preferred Education, Knowledge, Skills, Abilities:

• 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

Accountabilities:

• Exercises professional judgment and is vested with broad authority, as proxy of Principal Investigator, in implementing and monitoring research protocols
• Oversees work of study staff, including research assistants, interventionists, recruitment coordinators, student employees, etc.
• Responsible for incurring study-related costs in conformance with project budget, sponsor regulations, and institutional and department policy/procedure

Physical Requirements:
 

Ability to lift objects weighing 25# occasionally Ability to bend, stoop, grasp, and reach Not exposed to adverse environmental conditions; work is performed in indoor settings with climate control Able to complete work at a computer

Environmental Conditions:
 

Work is performed primarily inside under controlled environmental conditions and without exposure to adverse cold/heat conditions, vibration, heights, or loud noise.

Additional Job Description

Time Type Requirement

Full time

Note to Applicant:

This position profile identifies the key responsibilities and expectations for performance. It cannot encompass all specific job tasks that an employee may be required to perform. Employees are required to follow any other job-related instructions and perform job-related duties as may be reasonably assigned by his/her supervisor.

In order to provide a safe and productive learning and living community, Wake Forest University conducts background investigations and drug screens for all final staff candidates being considered for employment.

Equal Opportunity Statement

The University is an equal opportunity employer and welcomes all qualified candidates to apply without regard to race, color, religion, national origin, sex, age, sexual orientation, gender identity and expression, genetic information, disability and military or veteran status.  

 

Accommodations for Applicants

If you are an individual with a disability and need an accommodation to participate in the application or interview process, please contact AskHR@wfu.edu or (336) 758-4700.