DSMB Executive Secretary / Committee Coordinator

Saratoga Ascend; Oregon; Hybrid; USD 70,000 - 110,000; Full time

Job summary

Saratoga Medical is seeking a Remote, DSMB Executive Secretary / Committee Coordinator to support a NIH-style data and safety monitoring board. The role emphasizes meeting planning, minute-taking, and coordinating reports with statisticians and study teams.

Candidates should have a Bachelor's degree, at least 3 years supporting NIH/FDA-regulated clinical research, and solid knowledge of GCP, HIPAA, and related regulations. This remote position offers competitive pay and comprehensive benefits.

Qualifications

• Bachelor's degree or equivalent in life science, health, or related field.
• Minimum 3 years supporting data and safety monitoring boards or NIH-style committees.
• Knowledge of GCP, FDA regulations, HIPAA.
• Experience with NIH/FDA-regulated programs is preferred.
• Strong organizational and confidential information handling.

Responsibilities

• 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.
• Excellent organization, discretion and attention to detail when handling confidential information.
• Experience working in a multidisciplinary team environment with Government clinical investigators, regulatory staff and program officials.

Skills

Meetings scheduling

Minutes recording

Conflicts disclosure

Open/closed reports

Communication liaison

Discretion & organization

NIH/FDA experience

GCP knowledge

HIPAA training

Team collaboration

Education

Bachelor's degree in life science/health or related field

Job description

Saratoga Medical is hiring a Remote, DSMB Executive Secretary / Committee Coordinator.

Package includes competitive rate and benefit options.

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.