Kelly Services Clinical Trials Program Manager - NIH - Rockville, MD in Rockville, Maryland
Clinical Trials Program Manager – Site Monitoring & Regulatory Compliance * 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 Clinical Trials Program Manager with Site Monitoring & Regulatory Compliance experience 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 www.kellygovernmentsolutions.com at http://www.kellygovernmentsolutions.com/
TASKS/SERVICES : The contractor shall:
(1) Provide operational and project management support to Monitoring Operations Branch (MOB) for domestic and international clinical trial monitoring activities.
(2) Apply project management principles to tracking and driving monitoring initiatives to completion to strengthen regulatory compliance and operational efficiency.
(3) Work in conjunction with the Branch Chief, MOB to develop a strategic plan for process enhancement and work priorities within the branch.
(4) Facilitate process development initiatives within MOB regarding implementation of MediData RAVE at Division of AIDS (DAIDS) HIV/AIDS Network Data Management Centers.
(5) Provide oversight and tracking of all MOB’s initiatives and keep Branch Chief appraised of major milestones.
(6) Develop training materials and train relevant Office of Clinical Site Oversight (OCSO) staff on completed initiatives to enhance regulatory compliance.
(7) Provide subject matter expertise and senior technical advice to OCSO staff on clinical research operations, clinical trial monitoring, regulatory affairs, GCP, or other related clinical research issues such as: a) review of site trend analyses b) identification of concerns and solutions to site performance issues; and c) identifying opportunities for improving operations through site-specific training or site-specific monitoring visits.
(8) Attend Network meetings, conference calls, ad hoc meetings and working groups.
(9) Conduct trainings for sites and Network meeting participants on relevant monitoring policies and regulations.
(10) Assist with drafting and uploading reports to the OCSO SharePoint site (Portal).
(11) Interface with NIAID program staff and with the NIAID Clinical Site Monitoring (NCSM) contractor to support regular meetings related to task coordination.
(12) Participate in working groups to provide technical expertise in development of new Standard Operating Procedures (SOPs) and Work Instructions (WIs) for monitoring operations.
(13) Prepare oral and written presentations for internal and external programmatic and scientific meetings.
(14) Prepare briefings for OCSO Leadership. Identify issues, key findings and make recommendations for improvements or resolution of issues.
REQUIREMENTS : The contractor ideally would have:
(1) Master’s degree in Public Health, Biology, Nursing Education, or a related discipline. Three (3) years of specialized experience plus a BA/BS degree is equivalent to a Master’s degree.
(2) Experience with clinical trial project and protocol management
(3) Excellent applied knowledge of FDA regulations and ICH GCP guidelines to clinical research.
(4) Project Management Professional certification preferred, but not a required
(5) HIV/AIDS clinical research experience preferred, but not required.
(6) Excellent written and oral communication and interpersonal skills.
(7) Ability to work independently and as part of a team.
(8) Ability to proactively identify and research problems/issues thoroughly and use discerning judgment in problem solving for organization, management, and scientific issues using a significant degree of qualitative, quantitative, and analytical skill.
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.
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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