Manager, Clinical Research Operations, DC Cohort

Manager, Clinical Research Operations, DC Cohort

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Employer will not sponsor for employment Visa status. This position is a grant-funded position. Continuation of the position is contingent on grant funding.

I. DEPARTMENT INFORMATION

Job Description

Summary:

The DC Cohort is recruiting a Manager, Clinical Epidemiology Operations to work collaboratively with the Study PI, GWU Biostatistics Center MPI, and Project Director to oversee, coordinate, and manage day-to-day study operations. The NIH-funded DC Cohort is one of the largest urban HIV cohort studies in the US and captures electronic health information on consenting participants living with HIV, and at higher risk for HIV acquisition, at 14 clinical sites in Washington, DC.

Responsibilities include supervising GWU Senior Research Associates, ensuring regulatory and clinical compliance, overseeing clinical data collection and interpretation, and supporting manuscript preparation using the DC Cohort database. The Manager, Clinical Epidemiology Operations will also assist with regulatory submissions, program reports, funding proposals, work plans, and operations manuals, while working closely with partners at 14 clinical sites and other stakeholders to enhance and support the study’s growth and success.

Other duties and responsibilities include:

• Assist in the management of a complex research study, including implementation of strategic short and long-term objectives, related sub-studies and protocols, and creation and implementation of Standard Operating Procedures.
• Manage and track project and study timelines, ensuring adherence to workplans and deliverables.
• Supervise and provide guidance to GWU Senior Research Associates and the part-time Research Assistant, regarding the daily operations of the study.
• Ensure all research activities comply with relevant regulations, institutional policies, and ethical standards. Prepare submissions to the Institutional Review Board (IRB) and other regulatory bodies.
• Provide expert guidance on capture and interpretation of clinical data, both HIV and non-HIV-related, to ensure research data integrity.
• Liaise with internal and external stakeholders, facilitating effective communication.
• Ensure quality control measures are followed consistently across the research project.

Perform other related duties as assigned. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position.

Minimum Qualifications:

Qualified candidates will hold a BA/BS in a related discipline plus 6 years of relevant professional experience or, a BA/BS in a related discipline plus 5 years of relevant professional experience with a certification or, a Master’s degree or higher in a relevant area of study plus 4 years of relevant professional experience. Degree must be conferred by the start date of the position.

Additional Required Licenses/Certifications/Posting Specific

Minimum Qualifications:

• Advanced clinical healthcare degree such as Nurse Practitioner, Physician Assistant or Physician
• HIV clinical experience or HIV clinical research experience

Preferred Qualifications:

• Experience in study coordination, HIV/AIDS epidemiology, and/or other large clinical studies in the field or in a related area
• Strong understanding of Human Subjects Protections, Good Clinical Practice (GCP), and relevant regulatory requirements
• Extensive knowledge of HIV prevention, care, and treatment and general medical terminology
• Strong written and oral communication skills
• Proficiency with Microsoft applications, including Excel, Word, and Power Point

GW offers a comprehensive benefit package that includes medical, dental, vision, life & disability insurance, time off & leave, retirement savings, tuition, well-being and various voluntary benefits. For program details and eligibility, please visit (Use the "Apply for this Job" box below)..

II. POSITION INFORMATION

Campus

Location:

Campus

Location:

Foggy Bottom, Washington, D.C.

College/School/Department:

College/School/Department:
Milken Institute School of Public Health (SPH)

Family

Family Research and Labs

Sub-Family

Sub-Family Clinical…