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Executive Secretary / Committee Coordinator
Saratoga Ascend. Support data and safety monitoring boards, review committees or similar oversight bodies .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in supporting data and safety monitoring boards and clinical research programs, with a strong focus on organization, confidentiality, and communication within multidisciplinary teams. Proficient in maintaining compliance with regulatory standards and preparing detailed reports.
Highest-signal resume keywords
Data And Safety Monitoring Board SupportGood Clinical Practice KnowledgeMeeting CoordinationRegulatory Compliance ExperienceHuman Subjects Protections Training
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Meeting SchedulingAgenda DevelopmentMinute RecordingAction Item TrackingConflict-Of-Interest Disclosure MaintenanceReport PreparationStatistical CoordinationClinical Research SupportRegulatory DocumentationConfidential Information Handling
Soft Skills
Attention To DetailDiscretionExcellent OrganizationEffective CommunicationTeam Collaboration
Certifications & Qualifications
Current GCP TrainingCITI Training
Industry Keywords
NIHFDAClinical ResearchICH E621 CFRHIPAAMultidisciplinary TeamOversight BodiesStudy TeamsInvestigators
About the role
Key responsibilities & impact- Support data and safety monitoring boards, review committees or similar oversight bodies
- Schedule meetings, develop agendas and assemble meeting materials
- Record accurate, timely minutes and track action items and recommendations
- Maintain conflict-of-interest disclosures, member rosters and committee records
- Coordinate preparation of open and closed session reports with statisticians and study teams
- Serve as the communication link between DSMB members, investigators and NHGRI staff
- Handle confidential information with discretion and attention to detail
- Work alongside Government clinical investigators, regulatory staff and program officials in a multidisciplinary team
Requirements
What you’ll need- Bachelor's degree in a life science, health or related field preferred; equivalent experience may be substituted
- Minimum of 3 years of experience supporting data and safety monitoring boards, review committees or similar oversight bodies, preferably for NIH
- Scheduling meetings, developing agendas and assembling meeting materials
- Recording accurate, timely minutes and tracking action items and recommendations
- Maintaining conflict-of-interest disclosures, member rosters and committee records
- Coordinating preparation of open and closed session reports with statisticians and study teams
- Serving as the communication link between DSMB members, investigators and NHGRI staff
- Excellent organization, discretion and attention to detail when handling confidential information
- Five or more years of direct experience supporting NIH or FDA-regulated clinical research programs
- Working knowledge of Good Clinical Practice (ICH E6), 21 CFR Parts 11, 50, 54, 56, 312 and 812 (as applicable), 45 CFR Part 46, and HIPAA
- Current human subjects protections and GCP training (e.g., CITI or equivalent)
- Experience working in a multidisciplinary team environment alongside Government clinical investigators, regulatory staff and program officials
Benefits
Comp & perks- Competitive rate
- Benefit options