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14 days old

Clinical Documentation Specialist - TMF Experience - NIH - Rockville, MD

Kelly Services
Rockville, MD 20851
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 Trial Master File (TMF) Specialist at the National Institutes of Health in Rockville, 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 10 paid federal holidays and 401K plan.

- Access to NIHs unparalleled resources and niche scientific initiatives


TASKS/SERVICES. The contractor shall:

(1) Assist with the development, implementation, and maintenance of the Division of AIDS (DAIDS) Trial Master Files (TMFs) to meet regulatory requirements.

(2) Provide support and guidance to various functional areas supporting the TMFs, both electronic and paper.

(3) Provide support of DAIDS TMF operations during eTMF implementation, audits, and/or regulatory inspections.

(4) Ensure TMFs are inspection ready at all times and TMF documents are filed contemporaneously in a timely manner.

(5) Monitor and identify study trends, communicate issues, and escalate concerns to the federal client.

(6) Liaise with Regulatory, Quality, and other task area leads to reconcile TMF documents which have been received from various functional areas to ensure completeness and quality of files.

(7) Ensure compliance with ICH, U.S. federal regulations, and DAIDS policies and procedures.

(8) Assist in the tracking of all TMF activities (essential document submission and status).

(9) Develop SOPs as required to ensure oversight of the DAIDS TMF process


REQUIREMENTS. The contractor must have at least:

(1) Bachelors or masters degree in natural sciences, public health, nursing, or a related discipline

(2) Experience with clinical trial operations, trial master file, and/or or essential documents management.

(3) Solid understanding of trial master files organization, implementation and archival including other relevant regulations and guidance to assure quality of TMFs.

(4) Solid understanding of global ICH GCP requirements.

(5) Prior regulatory inspection experience a plus.


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 arent 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, Kellys Talent Promise confirms our commitment to those in search of a better way to work and live and to help discover whats 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.



**Why Kelly** **** **?**


Looking to connect with premier government agencies or the top 25 federal government contractors? Kelly Government offers a variety of full-time, project (SOW), seasonal, and surge support opportunities in science, engineering, technical, professional, and administrative support roles. Our experts will find you the opportunity that fits your schedule and interests and handle the details of transferring and processing all levels of security clearances. Its just another way we make the job search work for you.


**About Kelly** ****


Kelly connects talented people to companies in need of their skills in areas including Science, Engineering, Education, Office, Contact Center, Light Industrial, and more. Were always thinking about whats next in the evolving world of work, and we help people ditch the script on old ways of thinking and embrace the value of all workstyles in the workplace. We directly employ nearly 500,000 people around the world, and we connect thousands more with work through our global network of talent suppliers and partners in our outsourcing and consulting practice.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-02-15 Expires: 2021-03-22

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Clinical Documentation Specialist - TMF Experience - NIH - Rockville, MD

Kelly Services
Rockville, MD 20851

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