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 Research Coordinator with the National Institutes of Health in Rockville, Maryland.

　　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

　　Scope:

　　Under this Task Order, the Contractor(s) shall provide services in support of the overall functions of the DAIT/CROP .

　　Tasks:

　　Clinical Protocol Coordinator

　　• Serve as a Coordinator for NIAID Data and Safety Monitoring Board (DSMB) review activities in DAIT/CROP (In this document, DSMB shall refer to any safety monitoring body, including DSMBs, DMBs, or SMCs etc).

　　• Serve as the primary contact and coordinator between DAIT Senior staff, NIAID DSMB members, and DAIT CROP staff to schedule and support NIAID safety oversight reviews via the DSMB management Module of the NIAID Clinical Research Information System (NIAID CRMS(DAIT)).

　　• Participate in and moderate discussions for face-to-face NIAID DSMB meetings and/or teleconferences.

　　• Provide back-up and support to other CROP Team DSMB coordinators for each safety review.

　　• Train and provide daily support for new DSMB coordinators to perform DSMB pre-meeting functions and carry out meeting and teleconference support functions for CROP.

　　• Assist in the establishment and conduct of the meetings of the DAIT Clinical Research Committee (DCRC) including polling for Moderators, compiling the meeting memo etc and backing up the primary DCRC coordinator and serving as the meeting coordinator when required.

　　• Work collaboratively with relevant NIAID programmatic staff, administrative, and senior staff towards fulfillment of DAIT Clinical Research Operations Program (CROP) goals and objectives, services and deliverables.

　　• Provide primary administrative support for scheduling safety review meetings and/or teleconferences for DAIT Clinical Trials and posting/publishing agendas, conflict of interest forms, and other documents for review to the DAIT DSMB Module.

　　• Communicate with Division Protocol Teams regarding available DSMB review times, monitor and provide relevant meeting/discussion documents.

　　• Plan and maintain the DAIT/NIAID DSMB activities calendars for all DAIT-sponsored clinical trials.

　　• Coordinate pre-DSMB review(s) logistics: preparations, meeting rooms, conference calls, travel etc.

　　• Communicate with NIAID contractors to review draft and final NIAID meeting hotel contracts and meeting budgets.

　　• Complete training sessions for Board Members and NIAID staff regarding accessing, the use and operation of the NIAID CRMS(DAIT) DSMB module and provide access and assistance to module users.

　　• Manage DSMB Module documents and access permissions pertinent to DSMB reviews/meetings.

　　• Create, edit and manage draft and final agendas, all review materials, and all action item memos from the Boards to the Protocol Chairs (open and closed sessions) for each safety review.

　　• Provision the DSMB module to facilitate processing potential conflicts of interests for all DSMB Members, coordinating pre-DSMB review preparations, ensuring that highly confidential reports are routed to the appropriate DAIT staff via the DSMB Module.

　　• Track, manage and archive NIAID DSMB Members Conflict of interest (COI) forms and confidentiality statements for each safety review.

　　• Manage and track urgent and confidential clinical trial safety reports to ensure they reach the appropriate medical officers.

　　• Ensure that open session and closed session reports are released to the appropriate NIAID and Statistical contract staff, DSMB members and other personnel as appropriate.

　　• Take attendance during all DSMB review meetings and sessions, and track/archive the reported conflicts and recusals summary for each review to assure DAIT follows regulatory standards for the conduct of safety oversight reviews.

　　• Prepare and track confidential DSMB communications to participating investigators and the subsequent responses submitted back to the NIAID DSMBs following each data and safety review.

　　• Distribute summary action memos upon adjournment of each DSMB review to the principal investigator(s) for that specific trial.

　　• Review and track financial summaries of travel expenses from DSMB members to determine that expenditures are within the defined guidelines and prepare summary reports for supervisory approval.

　　• Prepare and file honoraria and travel reimbursements for participants in DSMB meetings.

　　• Review DSMB reimbursement and honoraria tracking reports.

　　• Assist with NIAID DSMB SOP development and revision.

　　• Assist with the development of Charters for NIAID DAIT DSMBs

　　• Assist in the design, evaluation, troubleshooting, maintenance and validation of IT systems supporting the DAIT/CROP DSMBs.

　　• Provide support to the NIAID/DAIT Clinical Research Management System (CRMS (DAIT)) and other CROP IT support systems including coordinating data uploads, systems design, planning, communications, data verification, validation and coordination of involved division staff.

　　• Provide back-up and support for other CROP functions related but not limited to serious adverse event tracking quality control, Human Subjects Protection (HSP), recording and distributing DAIT meeting minutes etc.

　　• Organize agendas for meetings, room reservations and teleconferences in support of CROP requirements, including CROP group meetings.

　　• Prepare and track CROPs annual travel plans and budgets.

　　• Write and review quality-related documents, including process descriptions, process flow diagrams, metrics, CAPAs, SOPs, Project Work Instructions (PWIs), and other documents as needed.

　　Specific Qualifications:

　　• Bachelor’s degree in Life Sciences or a related discipline is required.

　　• Minimum of three (3) years of experience in a related field is required.

　　• Expertise in the fundamentals of clinical trials.

　　• Strong organizational and communications skill including oral, written, and experience working with and creating detailed agendas, meeting logistics, document production and archiving

　　• Experience with MS Office; including Word, Excel, Outlook, & PowerPoint.

　　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.

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　　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.