Position Objective: Provide services as a Clinical Protocol Coordinator in support of the overall functions of the Division of AIDS (DAIDS), Clinical Research Operations Program (CROP) within the National Institute of Allergy and Infectious Diseases (NIAID).

Duties and Responsibilities:

• 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.

Basic 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.

Minimum Qualifications:

• Ability to communicate effectively, orally and in writing, with non-technical and technical staff.
• Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects.

*This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at recruiting@gapsi.com. You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.

GAP Solutions is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.

This position is contingent upon contract award.