Clinical Research Associates (CRA)
About the role
This position is patient-sensitive and must fulfill all associated vaccination requirements, or be approved for an exemption, prior to the first day of work. We protect our patients, coworkers and community by requiring all patient-sensitive employees to be immunized according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations.
The Clinical Research Associate monitors all aspects of clinical research, ensuring trial activities are conducted, recorded, and reported in accordance with protocols, SOPs, GCPs, medical review board standards, and applicable regulatory requirements.
Responsibilities
- Develop guidelines for collection of clinical data and administration of clinical trials.
- Conduct on-site visits for site selection, initiation, ongoing monitoring, and close-out.
- Evaluate investigator site practices for quality, integrity, and safety.
- Monitor progress of clinical trials at assigned investigative sites by tracking regulatory submissions, medical reports, recruitment, case report form completion, and study-related documents such as informed consent forms.
- Identify and escalate issues and implement corrective action to resolve issues.
- Conduct source data verification and review.
- Review adverse events with investigators, ensuring they are correctly documented and reported.
- Train investigators and other members of the study team.
- Serve as a recognized subject matter expert and advanced individual contributor, performing highly complex work unsupervised with extensive latitude for independent judgment.
Qualifications
Equivalency: 1 year of higher education can be substituted for 1 year of directly related work experience (e.g., bachelor's degree = 4 years of directly related work experience).
- Bachelor's degree (or equivalency) plus 8 years of directly related work experience, or master's degree (or equivalency) plus 6 years of directly related work experience.
Pay
Pay rate range: $60,000 – $90,