Job Description

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. Find out more here: .

The George Washington University School of Medicine and Health Sciences has an opening for a full-time Clinical Research Coordinator within the GW Vaccine Research Unit (GW VRU). The GW VRU conducts Phase I-III clinical trials to develop new vaccines for infectious and neglected tropical diseases such as COVID-19, HIV, hookworm, and schistosomiasis, at sites in the United States, Brazil, and Africa. The Clinical Research Coordinator will support the clinical research team in all aspects of clinical trial research activities. The candidate will report to the Clinical Research Manager.

This position supports complicated research projects in an assigned Practice Area through the performance of basic clinical and administrative procedures including data collection
and tracking. Provides support for Investigator-Initiated studies, phase 1 and other complex studies of all phases. This position will conduct clinical trial activities; will assist in the preparation of electronic and paper regulatory submissions, program reports, funding proposals, work plans and correspondence as needed. This position will conduct clinical trial activities, will analyze data, and will assist in the preparation of electronic and paper regulatory submissions, program reports, funding proposals, work plans, activity charts and correspondence as needed.

Responsibilities include:

• Coordinates day-to-day study operations and supports the research team in all aspects of clinical trial activities.
• Coordinates study recruitment efforts; assesses eligibility of potential study participants and schedules appointments; participates in the development and implementation of recruitment strategies.
• Maintains study documentation, training records, and investigator site files.
• Prepares submissions to the Institutional Review Board (IRB) and other regulatory bodies.
• Develops technical research documents (e.g., consent forms, case report forms, study protocols, technical reports).
• Conducts data entry and management utilizing Excel, REDCap, OnCore, and other clinical trial management systems.
• Communicates with sponsors, monitors, and other study collaborators.
• Conducts monthly chart audits for quality assurance and quality control.
• Attends study meetings; maintains minutes and agendas.
• Assists in the creation and revision of standard operating procedures (SOPs).
• Assists with invoices, supply orders, and inventory.
• Ensures compliance with all regulations governing the conduct of clinical trials in accordance with human research subject protections, Good Clinical Practice, Food and Drug Administration (FDA) regulations, federal and state laws, and institutional policies.

Performs other 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 and 2 years of experience in a related discipline. Degree must be conferred by the start date of the position. Certification preferred.

Additional Required Licenses/Certifications/Posting Specific Minimum Qualifications:

Preferred Qualifications:

• Excellent verbal and written communications skills is preferred.
• Excellent interpersonal, organizational, and problem-solving skills is desired. 
• Strong attention to detail, takes initiative, ability to multitask and prioritize.
• Experience in clinical research and/or project management is preferred.
• Proficiency with Microsoft Office, REDCap. is desired.

Hiring Range

$43,811.26 - $67,889.82

GW Staff Approach to Pay

Healthcare Benefits

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

II. POSITION INFORMATION

Campus Location:

Foggy Bottom, Washington, D.C.

College/School/Department:

School of Medicine and Health Sciences (SMHS)

Family

Research and Labs

Sub-Family

Clinical Research Operations

Stream

Individual Contributor

Level

Level 2

Full-Time/Part-Time:

Full-Time

Hours Per Week:

40

Work Schedule:

Monday - Friday, 8:30 am - 5:00 pm

Will this job require the employee to work on site?

Yes

Employee Onsite Status

Hybrid

Telework:

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?

No

Posting Number:

R002197

Job Open Date:

07/31/2024

Job Close Date:

If temporary, grant funded or limited term appointment, position funded until:

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/Affirmative Action 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.

Job Tags

Full time, Temporary work, Part time, Remote job, Work visa, Monday to Friday,

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