Are you an experienced CRA seeking your next career opportunity with a great company?
If so, we're seeking an individual who will qualify, initiate, monitor, and close out a number of clinical investigative sites under the supervision of various different internal teams. The CRA will assist with site and investigator recruitment, collecting documentation, and site management.
location: Norristown, Pennsylvania
job type: Permanent
salary: $75,000 - 90,000 per year
work hours: 9 to 5
- Qualify, initiate, monitor and close-out clinical investigative sites under supervision from Project Managers, Clinical Regulatory Managers, and Medical Directors.
- Provide ongoing assistance and education of investigational sites in principles of Good Clinical Practice as it relates to Research involving human subjects.
- Ensure subject safety through diligent monitoring of the site's compliance with study protocols, ICH-GCP guidelines and all applicable regulations.
- Monitor Case Report Forms
- Report, write narratives and follow-up on reported serious adverse experiences.
- Review submitted data and monitoring trip reports. Resolve issues from previous visits.
- Review recruitment plan and enrollment updates.
- Review site payment status.
- Assist and manage project budget
- Provide oversight of CROs, study vendors and laboratory vendors for adherence to deliverables, budget and timelines.
- Bachelor's degree required in Health Sciences or a related fields required.
- Minimum of 3 years' experience as a Clinical Research Associate required.
- Ability to travel, including overnight.
- Strong multi-tasking abilities and able successfully handle multiple priorities simultaneously.
skills: CRF, Clinical research, CRFs, GCP (Good Clinical Practice), Clinical Study Design, PSV (Pre-Study Visit), RMV (Routine Monitoring Visit), SIV (Site Initiation Visit), TR (Trip Report), ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.