9 days old

Trial Master File (TMF) Coordinator - NIH - Rockville, MD

Kelly Services
Rockville, MD 20851
Trial Master File (TMF) Coordinator ** NIH ** Rockville, MD

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 one of the most prestigious research organizations in the world. We are currently seeking a Trial Master File (TMF) Coordinator to work with the National Institutes of Health in Rockville, MD.

This is a long-term contract position which offers:

- Competitive salary with comprehensive benefit package

- Opportunity to work at NIH, world's foremost medical research center

- Learn more about what Kelly can do for you at at

**TASKS/SERVICES** : The contractor shall:

(1) Develop, implement, and maintain the Division of AIDS (DAIDS) Trial Master File (TMFs) to meet regulatory requirements.

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

(3) Provide oversight of 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 area specialists to reconcile TMF documents which have been received by functional groups to ensure completeness and accuracy of file reviews.

(7) Ensure DAIDS compliance with all Federal, State, local, and in-country regulations, policies and procedures.

(8) Assist in the tracking of all start-up activities (site and country study submissions and essential document status).

(9) Participate in Clinical Study team meetings.

(10) Develop SOPs as required and oversee the DAIDS TMF.

**REQUIREMENTS** : The contractor ideally would have:

(1) Masters degree or Ph.D. in natural sciences, public health, nursing, or a related discipline

(2) Extensive experience, which includes having positions of increasing responsibility in clinical operations, trial master file, or essential documents management.

(3) Solid understanding of global ICH GCP requirements including the recent updates.

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

(5) Prior regulatory inspection experience a plus.

(6) Strong interpersonal capabilities and ability to build and maintain networks.

(7) Ability to anticipate and resolve problems effectively, experience implementing TMFs.

(8) Strong verbal communication and technical writing skills.

(9) Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions.

(10) Motivates team members; fosters and nurtures teamwork.


Note that the phone number for our NIH branch is not listed. Due to the high volume of inquiries, we regret that we cannot accept phone calls. All qualified candidates will be contacted.

**AboutKelly Services** ****

As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit and connect with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at
Posted: 2019-01-11 Expires: 2019-02-11

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Trial Master File (TMF) Coordinator - NIH - Rockville, MD

Kelly Services
Rockville, MD 20851

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