Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with leading medical research centers, biotechnology and pharmaceutical development companies in the world. We are seeking individuals qualified to work as a Clinical Protocol Coordinator to support the mission of the National Institutes of Health (NIH).
This is a long-term contract position which offers:
- Competitive compensation and comprehensive benefit package
- Optional health, vision, and dental plans
- Vacation leave as well as 10 paid federal holidays and 401K plan.
- Access to NIH’s unparalleled resources and niche scientific initiatives
Duties Include:
- Assist with managing clinical protocols by assembling and coordinating the study team; oversee compliance to protocol; develop and adhere to relevant SOPs; monitor quality control, complete and submit study related documentation; prepare, submit and maintain IRB, FDA, and/or other regulatory documents and research correspondence.
- Monitor study enrollment goals and initiate strategies to promote enrollment and participant compliance.
- Coordinate and perform tasks related to research participants which includes determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, obtaining informed consent and overseeing study visits.
- Provide a wide range of nursing assistant duties as well as being responsible for basic clerical and office automation duties.
- Upon patient's admission, take vital signs, orient patients with the clinic, and assist them with discharge procedures.
- Receive patient care phone calls, furnish requested information, or refer callers to the appropriate staff members.
- Compile, edit, type weekly projected census admission lists and extract required patient statistics from the Medical Information System (MIS) database, and assist in medical documentation.
- Obtain medical records from primary care physicians and review medical records for enrollment eligibility.
- Review and prepare participant charts and record lab results for all new enrollments.
- Monitor study enrollment goals and initiate strategies to promote enrollment and participant compliance.
- Coordinate and perform responsibilities related to research participants including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, obtaining informed consent and overseeing study visits.
- Prepare for and coordinate site visits made by sponsors or study monitors during the course of and at the close of the study.
- Assist and coordinate the collection, processing, shipment and storage of biospecimens.
- Manage close-out of clinical protocols including audit preparation, trial closure, and communication with regulatory agencies, assisting in the final study report and completing financial obligations.
Requirements:
- BS in a related field is required.
- Minimum of four (4) years of experience in related field is required.
- Good communication skills and writing skills are highly desired.
- Must complete all security and training for use of NIH databases and software, and must follow and adhere to PII regulations.
- Experience using Microsoft Office products including Outlook, Sharepoint, MS Teams;
- Experience with NIH’s CRIMSON and CRIS software is preferred, although training will be provided for documentation and clinical systems used by the clinical research teams.
PLEASE APPLY ONLINE
When you apply, please know a Kelly Government Solutions Recruiter will review your resume and will contact you directly, if your skills and experience match the requirements of this position; a full job description can be made available at that time.
Due to the high volume of inquiries, we regret that we cannot accept phone calls. Even if you aren’t contacted for this position, you are still part of our talent network. All Kelly recruiters have access to your profile, which expands your opportunities even further.
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You should know: Vaccination against COVID-19 is a requirement for all job opportunities offered through Kelly Government Solutions, in accordance with the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors.