DSMB Executive Secretary / Committee Coordinator

Saratoga Medical Center; United States; À distance; USD 65 000 - 90 000; Plein temps

Résumé du poste

Saratoga Medical Center in the United States is seeking a Remote DSMB Executive Secretary / Committee Coordinator to support data and safety monitoring boards, review committees or similar oversight bodies. The role emphasizes confidentiality, meticulous record-keeping and coordination of meeting materials.

Responsibilities include scheduling, minute-taking, tracking action items, maintaining COI disclosures, and coordinating open/closed session reports with statisticians and study teams.

Qualifications

• Bachelor's degree in a life science, health or related field preferred.
• Minimum 3 years of experience supporting data and safety monitoring boards, review committees or similar oversight bodies, preferably for NIH.
• 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 coordinating open and closed session reports with statisticians and study teams; serving as communication link between DSMB members, investigators and NHGRI staff; maintaining confidential information.

Responsabilités

• 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
• Experience working in a multidisciplinary team with Government clinical investigators, regulatory staff and program officials

Connaissances

Meeting scheduling

Minutes recording

COI disclosures

Open/closed reports coordination

Interagency communication

Discretion and confidentiality

NIH/FDA clinical research knowledge

GCP knowledge (ICH E6)

HIPAA knowledge

Team collaboration

Formation

Bachelor's degree in life science/health

Equivalent experience accepted

Description du poste

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

DSMB Executive Secretary / Committee Coordinator

Remote, US

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.