Data & Safety Monitoring Committee Coordinator
We are currently searching for a Data & Safety Monitoring Committee Coordinator to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC and it is on-site in Rockville, MD.
Duties & Responsibilities
- Serve as the primary contact and coordinator between Senior staff, Program members, and other NIH staff to schedule and support safety oversight reviews via the management Module of the Clinical Research Information System.
- Participate in and moderate discussions for face-to-face NIH meetings and/or teleconferences.
- Provide back-up and support to other program team coordinators for each safety review.
- Train and provide daily support for new program coordinators to perform pre-meeting functions and carry out meeting and teleconference support functions for the program
- Assist in the establishment and conduct of the meetings for the Clinical Research Committee including polling for Moderators, compiling the meeting memo etc.; and backing up the primary program coordinator and serving as the meeting coordinator when required.
- Work collaboratively with relevant NIH programmatic staff, administrative, and senior staff towards fulfillment of program goals and objectives, services and deliverables.
- Provide primary administrative support for scheduling safety review meetings and/or teleconferences for program posting/publishing agendas, conflict of interest forms, and other documents for review.
- Communicate with Division Protocol Teams regarding available review times, monitor and provide relevant meeting/discussion documents.
- Plan and maintain the program activities calendars for all sponsored clinical trials.
- Coordinate pre-program review(s) logistics: preparations, meeting rooms, conference calls, travel etc.
- Communicate with NIH contractors to review draft and final meeting hotel contracts and meeting budgets.
- Complete training sessions for Board Members and NIH staff regarding accessing, the use and operation of the program module and provide access and assistance to module users.
- Manage program module documents and access permissions pertinent to program 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 program module to facilitate processing potential conflicts of interests for all program members member, coordinating pre-program review preparations, ensuring that highly confidential reports are routed to the appropriate program staff via the module.
- Track, manage and archive 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 NIH and Statistical contract staff, program members and other personnel as appropriate.
- Take attendance during all review meetings and sessions, and track/archive the reported conflicts and recusals summary for each review to assure program follows regulatory standards for the conduct of safety oversight reviews.
- Prepare and track confidential program communications to participating investigators and the subsequent responses submitted back to the appropriate teams, following each data and safety review.
- Distribute summary action memos upon adjournment of each review to the principal investigator(s) for that specific trial.
- Review and track financial summaries of travel expenses from team 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 program meetings.
- Review reimbursement and honoraria tracking reports.
- Assist with program development and revision.
- Assist with the development of Charters for the program.
- Assist in the design, evaluation, troubleshooting, maintenance and validation of IT systems supporting the program.
- Provide support to the Clinical Research Management System (CRMS) and other program 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 program functions related but not limited to serious adverse event tracking quality control, Human Subjects Protection (HSP), recording and distributing program meeting minutes etc.
- Organize agendas for meetings, room reservations and teleconferences in support of program requirements, including group meetings.
- Prepare and track annual travel plans and budgets.
- Write and review quality-related documents, including process descriptions, process flow diagrams.
- 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.
- Expertise in the following preferred:
- Data and Safety Monitoring
- Good Clinical Practices and Human Subject Protection Procedures
- Clinical Data Management, and Database operations
- Developing and Utilizing Web-Based Information Systems
- Utilizing OneNote, OneDrive and Visio.
- Working in a quality-based environment
Due to our contractual requirements and federal orders, including an Executive Order from the White House and an emergency regulation from the Centers for Medicare & Medicaid Services (CMS), the position for which you are applying requires that you provide proof of your vaccination status. If you are unable to receive the COVID-19 vaccine for medical reasons or because of a sincerely held religious belief, you may request an exemption from the vaccination requirement which shall be reviewed after the submission of requested documentation. If an accommodation is granted, the conditions may include weekly testing and masking. All Guidehouse employees also agree to follow any additional health and safety mitigation policies that may be required in the workplace.
Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.
Guidehouse is a leading global provider of consulting services to the public sector and commercial markets, with broad capabilities in management, technology, and risk consulting. By combining our public and private sector expertise, we help clients address their most complex challenges and navigate significant regulatory pressures focusing on transformational change, business resiliency, and technology-driven innovation. Across a range of advisory, consulting, outsourcing, and digital services, we create scalable, innovative solutions that help our clients outwit complexity and position them for future growth and success. The company has more than 12,000 professionals in over 50 locations globally. Guidehouse is a Veritas Capital portfolio company, led by seasoned professionals with proven and diverse expertise in traditional and emerging technologies, markets, and agenda-setting issues driving national and global economies.
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