Manager, Clinical Research Operations, DC Cohort

The DC Cohort is recruiting a Manager, Clinical Research Operations, DC Cohort 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 Research Operations, DC Cohort 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:

1. 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.
2. Manage and track project and study timelines, ensuring adherence to workplans and deliverables.
3. Supervise and provide guidance to GWU Senior Research Associates and the part-time Research Assistant, regarding the daily operations of the study.
4. 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.
5. Provide expert guidance on capture and interpretation of clinical data, both HIV and non HIV-related, to ensure research data integrity.
6. Liaise with internal and external stakeholders, facilitating effective communication.
7. 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.

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.

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

The university is an Equal Employment Opportunity employer that does not unlawfully discriminate in any of its programs or activities on the basis of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity or expression, or on any other basis prohibited by applicable law.