Senior CRA / Clinical Trial Monitor
United StatesJust now
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Key details
- Location
- United States
- Work style
- Remote
- Level
- Senior
- Experience
- 5–8 yrs
- Function
- Healthcare
- Focus area
- other
- Posted
- Just now
Skills
About the role
Saratoga Medical is hiring a Remote, Senior CRA / Clinical Trial Monitor. 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, nursing or health-related field; clinical research certification (CCRA, CCRP) preferred.
Experience: Minimum of 5 years of clinical monitoring experience, with at least 3 years on NIH- or FDA-regulated trials.
Qualifications:
- Hands-on experience conducting site initiation, interim monitoring and close-out visits, on-site and remote
- Expertise in source document verification, informed consent review, and protocol and GCP compliance assessment
- Experience reviewing adverse event and serious adverse event documentation and reporting
- Experience with investigational product accountability, storage and reconciliation
- Ability to write clear monitoring reports, identify deficiencies, and develop and track corrective and preventive actions (CAPA)
- Willingness and ability to travel as required
- 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.