DSMB Executive Secretary / Committee Coordinator
United StatesJust now
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Key details
- Location
- United States
- Work style
- Remote
- Level
- Mid level
- Experience
- 3–6 yrs
- Function
- Administrative
- Focus area
- other
- Posted
- Just now
Skills
About the role
Saratoga Medical is hiring a Remote, DSMB Executive Secretary / Committee Coordinator. Package includes competitive rate and benefit options. Please see qualifications below and submit your resume if you are interested in being considered:
Education: Bachelor's degree in a life science, health or related field preferred; equivalent experience may be substituted.
Experience: Minimum of 3 years of experience supporting data and safety monitoring boards, review committees or similar oversight bodies, preferably for NIH.
Qualifications:
- 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
Saratoga Medical Center, Inc. is an equal opportunity employer and will not discriminate in recruiting, hiring, training, promotion, transfer, discharge, compensation or any other term or condition of employment on the basis of race, religion, color, age (over age 39), sex, national origin, or on the basis of disability if the employee can perform the essential functions of the job, with a reasonable accommodation if necessary.