Clinical Protocol Coordinator
Job opening ID
Clinical Protocol Coordinator
Roles and responsibilities
Must be a US Citizen
Some travel may be required
Columbus Technologies and Services Inc. is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Columbus 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 Protocol Coordinator 1 to work onsite with the National Institutes of Health in Rockville, MD.
This is a long-term contract position which offers:
- Competitive salary
- Tremendous growth opportunity
- Opportunity to work at NIH, the world's foremost medical research center
- Learn more about what Columbus can do for you at www.columbususa.com
•Evaluate potential conflicts of interest (COIs) for all DSMB, DMC and SMC members.
•Coordinate the DSMB, DMC and SMC meeting scheduling and all related necessary lo-gistics.
•Coordinate pre-DSMB, DMC and SMC review(s) logistics: preparations, meeting rooms, conference calls.
•Maintain the DAIT, NIAID DSMB/DMC/SMC review activities calendar for all Safety Oversight reviews across DAIT Branches/Programs.
•Ensure that open session and closed session reports are released to the appropriate NIAID staff and DSMB, DMC and SMC members.
•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.
•Create agendas for upcoming DSMB, DMC and SMC reviews.
•Communicate with Division Protocol Teams regarding available DSMB, DMC and SMC review times, oversee and provide relevant meeting/discussion documents.
•Oversee and assess DSMB, DMC and SMC meeting details (e.g., face-to-face, telecon-ference, etc.).
•Manage DSMB Web Portal documents pertinent to DSMB, DMC and SMC reviews/meetings.
•Distribute summary action memos upon adjournment of each DSMB, DMC and SMC re-view to the principal investigator(s) for that specific trial.
•Complete training sessions for new DAIT DSMB Web Portal users and provide assis-tance/guidance to portal access users.
•Upload and maintain completed Conflict of Interest (COI) forms, safety review materi-als, and related documents into the secure NIAID Livelink Electronic Document and Records Management System (EDRMS).
•Review and track financial summaries of travel expenses from DSMB, DMC and SMC members to determine that expenditures are within the defined guidelines and, prepare summary reports for supervisory approval.
•Manage and track confidential clinical trial safety reports to ensure they reach the appro-priate medical officers.
•Communicate with the NIAID contractor to review draft and final NIAID meeting hotel contracts and meeting budgets.
•Coordinate assigned clinical trial protocol development activities with: DAIT CROP staff; NIAID Project Managers, Medical Officers, Program Officers, and Project Officers; associated contracting clinical research organizations, and NIAID administrative staff.
•Prepare and track annual travel plans and budgets for: individual DSMBs, DMCs, and SMCs; scientific staff members based on programmatic relevance, including but not limited to prioritization of committee meetings, site visits, scientific meetings and invited lectures.
•Coordinate and manage assigned activities for individual Steering Committees of CROP sponsored programs.
•Provide support to NIAID project managers regarding Site Roster Updates.
•Provide feedback and edit suggestions to NIAID regarding DRAFT Standard Operating Procedures (SOPs); perform literature searches relevant to CROP initiatives, assignments, services and deliverables.
•Organize site visits with Project Officer and meeting support contractor.
•Bachelor’s degree in Life Sciences or a related discipline.
•Two (2) years of experience in a related field.
•Knowledge of clinical protocols and medical terminology.
•Proficiency in the operation of computer and general data acquisition programs.
•Familiarity with IRB requirements.
Number of positions