Description
Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with the leading medical research center in the world. We are seeking an individual to work on-site as a Senior Clinical Protocol Coordinator supporting the National Institute of Dental and Craniofacial Research (NIDCR) in Bethesda, MD.
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 paid federal holidays and 401K plan.
- Access to NIH's unparalleled resources and niche scientific initiatives
TASKS/SERVICES. The contractor shall:
(1) Provide clinical research support including direct protocol management and implementation support to the clinical research program within the National Institute of Dental and Craniofacial Research (NIDCR) Office of the Clinical Director (OCD)
(2) Provide oversight and management of the clinical research program supported by the Institute
(3) Work closely with all NIDCR clinical research teams to navigate clinical studies through various phases of the protocol lifecycle while at the same time ensuring regulatory compliance with NIH, local, state, and federal policies/procedures
(4) Work directly with the NIDCR study teams in the development of clinical research documents including research protocols, informed consent documents, case report forms, study team worksheets and other documents to guide the preparation of regulatory agency reports, including IRB, DSMC, Scientific Review and FDA documents
(5) Work closely with Protocol Navigators to ensure IRB submissions are accurate and timely, provide quality reviews of NIDCR clinical research protocols and associated documents
(6) Stay abreast of all Human Subject Protections and research-related regulations and policies including but not limited to all NIH, local, state, and federal regulations (i.e. FDA, IRB, ICH).
(7) Educate and provide guidance to clinical research investigators, research nurses/coordinators, patient care coordinators and other research support staff in clinical research and regulatory compliance
(8) Prepare summaries of information for review by NIH staff responsible for managing and overseeing clinical research programs
(9) Update and maintain electronic and paper files; copy and distribute materials as needed
(10) Work with Institute leadership staff and clinical study staff members to coordinate logistics for in-person meetings, monthly teleconferences, or videoconferences, prepare meeting materials, such as spreadsheets, letters, rosters, agendas, presentations, and meeting minutes/summaries.
(11) Attend NIH-wide forums pertinent to role including monthly Protocol Navigator meetings, OHSRP educational offerings and IRB forums
REQUIREMENTS. The contractor must have:
(1) Master's degree in a science or health-related discipline. Three (3) years of specialized experience plus a bachelors degree is equivalent.
(2) Minimum of five (5) years of work experience in a clinical research environment that includes clinical research coordination, clinical trial program management, and/or clinical trials operational support
(3) Knowledge of the roles, responsibilities, policies, and regulations related to regulatory bodies (i.e. FDA, IRB) with governance over clinical research
(4) Ability to work on-site in the NIH Clinical Center in Bethesda, MD.
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.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, short-term disability, and a transportation spending account.
Visit https://www.mykelly.us/us-mykelly/perks/ for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Government Solutions?
Looking to connect with premier government agencies or the top 25 federal government contractors? Kelly Government Solutions partners with these organizations to create expert talent solutions that solve the world's most critical challenges. We offer a variety of full-time, project (SOW), seasonal, and surge support opportunities in science, engineering, technology, professional, and administrative support roles. Our experts will connect you to the opportunity that fits your schedule and interests and handle the details of transferring and processing all levels of security clearances. It's just another way we make the job search work for you.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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