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12 days old

Clinical Advisor - 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 one of the most prestigious research organizations in the world. We are currently seeking a Clinical Advisor to work onsite 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, the world's foremost medical research center



- Learn more about what Kelly can do for you at www.kellygovernmentsolutions.com





TASKS: The contractor shall:




+ Provide operational support to Contracting Officers Representative (COR) for Division- supported contracts providing clinical trial monitoring services in the context of domestic and international settings.

+ Provide advice on clinical research operations, regulatory affairs, GCP, or other related clinical research issues such as: a) review of site trend analyses or site monitoring reports; b) identification of concerns and solutions to site performance issues; and c) identifying opportunities for improving operations through site-specific training or site-specific visits.

+ Assist in the development of tools and processes that will improve the effectiveness and efficiency of clinical monitoring.

+ Develop Protocol Specific Monitoring Plans tailored to specific human subject protection and data integrity risks of the trial.

+ Shadow monitoring visits to sites as necessary to assess compliance and potential challenges.

+ Potential responsibility for oversight of a small portfolio of Clinical Research Sites (CRS) (Network and Non-Network). For these sites, serve as the day-to-day contact for CRS staff to facilitate clinical research site development, protocol implementation, and other operational and regulatory issues. Advise Principal Investigators on clinical site start-up issues including resource allocation, personnel management and administrative issues. Sites may be Network affiliated sites or investigator-initiated project (Non-network) sites.

+ Direct and conduct formal evaluations of the CRSs organizational structures and modes of operation in relationship to the achievement of the Divisions goals and objectives in the areas of administration, clinical site management, and recruitment of participants.

+ Provide oversight and technical direction for evaluation of site performance using data compiled by Network/Non-network data management centers and other DAIDS contractors.

+ Assess the level of clinical research competency of CRSs and the extent of research knowledge and technology available to achieve the desired quality of operations at the clinical research sites.

+ Attend Network meetings, conference calls, ad hoc meetings and working groups as needed.

+ As needed, conduct trainings for sites and Network meeting participants on relevant policies and regulations.

+ Assist with drafting and uploading reports to the OCSO SharePoint site (Portal).

+ Interface with NIAID program staff and with the Clinical Site and Study Monitoring (CSSM) contractor to support regular meetings related to task coordination.

+ Participate in working groups to provide technical expertise in development of new OCSO policies and standard operating procedures (SOPs).

+ Review and participate in drafting new procedures and work instructions for monitoring contract services.

+ Prepare oral and written presentations for internal and external programmatic and scientific meetings.





REQUIREMENTS: The contractor must have:




+ Masters degree in a related discipline. Three (3) years of specialized experience plus a BA/BS degree is equivalent to a Masters degree.

+ Minimum of eleven (11) years of experience in clinical trial monitoring, regulatory affairs, and Good Clinical Practice.

+ Knowledge of FDA regulations and ICH guidelines pertinent to clinical research.

+ Working knowledge of clinical data management tools, such as Medidata RAVE.

+ Experience in developing SOPs.

+ Certified CRA preferred.

+ Excellent written and oral communication and interpersonal skills.

+ Ability to work independently and as part of a team.

+ Excellent analytical, organizational, and time management skills.





PLEASE APPLY ONLINE



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 kellyservices.com 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 https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2020-01-06 Expires: 2020-02-06

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Clinical Advisor - NIH - Rockville, MD

Kelly Services
Rockville, MD 20851

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