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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 experienced individual to work as a Clinical Research Project Manager (QC & Recruitment/Outreach) at the National Institutes of Health in Bethesda, MD. This position will require work to be performed on-site at the NIH 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 support in quality control review and clinical operations outreach to ensure compliance within protocol/research standards specific to clinical trial development, recruitment, outreach, and research data collection, and general clinical operations with use of the Clinical Trials Program (CTP) Quality Management System (QMS)

(2) Actively contribute to the accurate retention of complex clinical data and records by acting as Quality Control and Clinic Outreach Liaison

(3) Ensure adherence to International Commission on Harmonization (ICH), Good Clinical Practice (GCP), and Code of Federal Regulations (CFR).

(4) Ensure clinical notes adhere to protocol requirements, accurate input of clinical data and records information, aligning database cross-communications to secure data integrity.

(5) Verify that trial data is consistent with patient clinical notes and other source documentation

(6) Provide recommendations and guidance to study specific monitoring teams and assist in audit readiness and preparation.

(7) Audit research records, source documentation and practices to monitor compliance with applicable regulations. Identify areas of potential risk through audit processes, as well as assist with presentation of audit findings and design and monitoring of necessary corrective action.

(8) Identify training opportunities based on audits, design and present such education to prevent repeated compliance risks.

(9) Work closely with safety office team and research nurses/study coordinators to oversee the data management process.

(10) Perform monitoring support and quality control (QC) checks on all trials as needed

(11) Perform internal QC monitoring visits to ensure research data accuracy, consistency, accountability, documentation, and methods or procedures through review of CRFs, source documents, medical records, and regulatory documents.

(12) Assist in the overall recruitment and pre-screening effort of the team in accordance with each protocol utilizing Vaccine Research Center (VRC) screening process criteria, in person or by telephone.

(13) Schedule participant screening visits in the VRC scheduling database; collect and enter initial pre-screening health and demographic information in database by interviewing subjects to determine protocol eligibility

(14) Assist with and participate in community engagement (in a variety of settings including college campuses, community events, and community-based organizations) and study recruitment plans/strategies, to include marketing, community outreach, health education, etc. for all VRC clinical research studies in order to increase enrollment and name recognition

(15) Assist in the development of recruitment materials such as data sheets, brochures, pre-screening documents, advertisement and other materials as appropriate for each engagement.

(16) Assist team members with the day-to-day clinical administrative ops tasks, such as copying, filing and clinical data entry; maintain tools and supplies to ensure proper recruitment for research studies.

REQUIREMENTS. The contractor must have:

(1) Bachelor’s degree in a related field.

(2) Minimum of two (2) years of experience in clinical research.

(3) Strong organizational and communication skills with demonstrated ability to simultaneously manage multiple projects.

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.

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 a specialty talent company, Kelly is committed to doing the right thing for our talent and clients. We stand up for equity, inclusion, fair treatment, and opportunity for all as these build the foundation of our Talent Promise. With a focus on safety, value, well-being, investment, and opportunity, Kelly’s Talent Promise confirms our commitment to those in search of a better way to work and live and to help discover what’s next.

It is obvious things are different than they were just a few months ago. Kelly is at the forefront of ensuring the safety of our employees in this new working environment. Be well and stay strong.

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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 (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s 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.