Manager, Clinical Research Operations

The George Washington University

Washington (District of Columbia)

On-site

USD 120,000 - 180,000

Full time

8 days ago

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Job summary

The George Washington University in Washington, DC, seeks a leadership-level Clinical Research Manager to supervise and train clinical research staff, ensure compliance with CFR, ICH, and GCP guidelines, and support IRB protocols and IND submissions. You will collaborate with PIs, sponsors, and finance to manage budgets and timelines.

Responsibilities include coordinating staff, developing monitoring tools, overseeing recruitment targets, and handling billing for funded trials, with a strong

Qualifications

BA/BS in a related discipline with 6 years of relevant professional experience.
BA/BS in a related discipline with 5 years of relevant professional experience plus a certification.
Master’s degree or higher in a relevant area with 4 years of relevant professional experience.

Responsibilities

Coordinate and supervise Clinical Research Staff.
Provide training and conduct regular meetings with staff.
Oversee new employee orientation for clinical research staff.
Lead development and oversight of departmental clinical operations for research protocols.
Collaborate with Principal Investigators and sponsor to set recruitment targets and ensure compliance.
Assist with writing and submission of IRB protocols and IND applications.
Create and implement study-specific clinical monitoring tools and documents.
Create and oversee trial budgets in collaboration with Finance.
Assist with billing, invoicing, and tracking for funded trials.
Resolve billing issues in collaboration with relevant departments.
Take on special projects as needed by leadership.

Skills

High emotional intelligence

Strong analytic skills

Superb organizational skills

Education

BA/BS in related discipline

Master's degree or higher in relevant area

Job description

Please see Special Instructions for more details.

Employer will not sponsor for employment Visa status

I. DEPARTMENT INFORMATION

Job Description Summary:

Founded in 1824, the GW School of Medicine and Health Sciences ( SMHS ) is the 11th oldest medical school in the country and the first in the nation’s capital. Since its establishment, the school has been at the forefront of medical education, and has grown to include highly-ranked programs in the health and biomedical sciences. With dozens of top-tier residency programs, SMHS is a competitive and esteemed destination for medical school graduates across the country.

This position is a leadership position that supervises clinical research staff assigned and is responsible for the conduct/implementation of clinical trials in the Department of Neurology. This position ensures that our research staff are appropriately trained on the Federal Regulations as well as GW University Policies and Procedures governing research activities so that research is conducted in the most compliant manner.
Responsibilities include:

Coordinate and supervise Clinical Research Staff.
Provide subordinates with project-specific training and have regular meetings with them.
Oversee new employee orientation of clinical research staff.
Lead development and oversight of departmental/divisional clinical operations for research protocols including recruitment, screening, enrollment, informed consent, any clinical procedures required by the protocol such as physical exams, imaging, specimen collection, survey completion, participant reimbursements and tracking.
Collaborate with the Principal Investigators and sponsor to set targets for clinical recruitment and ensuring recording of trial in compliance with project goals.
Assist the Principal Investigators in writing and submitting IRB protocols.
Assist the Principal Investigators with IND applications to the FDA including preparation of IND applications.
Create and implement study-specific clinical monitoring tools and documents.
Create and oversee trial budget in collaboration with the Manager of Clinical Research Finance.
Take on Clinical trials as needed
Work with clinical research coordinators and other staff to prepare informed consent forms, review and prepare informed consent changes for appropriate language. Must have thorough understanding of guidelines in consent language, being able to explain, in detail, what is within the research protocol and its impact on the potential subject.
Coordinate, arrange and oversee site visits from sponsors.
Gather and examine trial documents.
Assure compliance SOPs and local regulations, and CFR , ICH and GCP guidelines.
Provide assistance to faculty in preparing grant proposals and help identify funding sources and opportunities for research.
Assist with monthly billing/invoicing for funded clinical trials; verifying financial data for accuracy, completeness and conformance with clinical trial study budgets and includes accurate input of budget and payment milestones into tracking systems.
In collaboration with the Clinical Research Finance Manager follow monthly tracking of payments and payment issues so that contracts and budgets can be renegotiated if necessary. Assist in monitoring outstanding invoices, tracking collection, reducing accounts receivable balance.
Assist GW investigators in resolving research-related billing issues (in collaboration with individuals in the MFA and Hospital).
Take on special projects or tasks as required and needed by the Director of the CTO .

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:

Preferred Qualifications:

High emotional intelligence
Strong analytic skills
Superb organizational skills, attention to detail and follow through

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 https://hr.gwu.edu/benefits-programs.

II. POSITION INFORMATION

Campus Location:

Campus Location: Foggy Bottom, Washington, D.C.

College/School/Department:

College/School/Department: School of Medicine and Health Sciences (SMHS)

Family

Family Research and Labs

Sub-Family

Sub-Family Clinical Research Operations

Stream

Stream Management

Level

Level Level 2

Full-Time/Part-Time:

Full-Time/Part-Time: Full-Time

Hours Per Week:

Hours Per Week: 40

Work Schedule:

Work Schedule: Monday - Friday 8:00AM - 5:00PM

Will this job require the employee to work on site?

Will this job require the employee to work on site? Yes

Employee Onsite Status

Telework:

Required Background Check

Required Background Check Criminal History Screening, Education/Degree/Certifications Verification, Social Security Number Trace, and Sex Offender Registry Search

Special Instructions to Applicants:

Employer will not sponsor for employment Visa status

Internal Applicants Only?

Internal Applicants Only? No

Posting Number:

Posting Number: R002451

Job Open Date:

Job Open Date: 08/11/2026

Job Close Date:

Background Screening Successful Completion of a Background Screening will be required as a condition of hire.

EEO Statement:

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.

Posting Specific Questions

Required fields are indicated with an asterisk (*).

* Are you currently employed with The George Washington University?
- No
- Yes
* For current GW employees, have you completed your Introductory Employment Period (IEP)? (As a reminder,employees in their IEP are not eligible to apply for other internal university staff and research positions until the IEP is complete.)
- Yes, IEP complete
- No, still in IEP
- N/a - not a current GW employee
* What is your expected salary range?
(Open Ended Question)

Required Documents