Research Regulatory Coord 1
St. Luke’s Health System
This is a Full-time position in Boise, ID posted January 9, 2022.
You take care of others, so take care of yourself.
Let us be your partner in health, whether you’re recovering from an injury, checking in for your annual exam, or enjoying an online class.
Because when you take care of yourself, everyone around you benefits.
St.
Luke’s Health System in Boise, Idaho is seeking a Research Regulatory Coordinator 1 to join our research team.
The research regulatory coordinator will provide support for oncology pharma studies for both adult and pediatric studies.
Providing a good work life balance with option to work a hybrid schedule.
Overseeing the non-clinical research activities for these trials and supporting our study team operations from a regulatory perspective.
The selected individual will handle the majority of communications with our Study Sponsors and serves as a project manager for each individual study.
The research team relies on this individual to keep them abreast of protocol and regulatory requirements for each trial and to review and submit applications to the applicable institutional review boards ensuring our site stays in regulatory compliance.
Responsibilities
- Prepares and submits regulatory documents for all submissions to St.
Luke’s Research and the IRB of record on behalf of investigators.
- Maintains current regulatory documents in accordance with federal and state regulations, as well as institutional policies.
- Develops appropriate regulatory reports and associated documentation in accordance with institutional policies, procedures, and study specific processes.
- May prepare and maintain safety reports for submission to the IRB and/or sponsor.
- Monitors various external websites to access protocol revisions, updates, safety reports etc.
- Ensures Principal Investigator and research staff have access to current versions of all study documents and training materials.
- May participate in creation, implementation, and documentation of study specific training.
- Manages appropriate databases, websites, and clinical trial management systems.
- Acts as a liaison with sponsors, research staff, and non-research personnel.
- Prepares for and conducts study monitor visits and various audits.
- May participate in development of regulatory policies and procedures.
- Performs other duties and responsibilities as assigned.
Qualifications
- Education: Bachelor’s Degree or 4 years relevant experience in lieu of degree.
- Experience: 2 years of additional relevant experience.
- Licenses/Certifications: None
Why St.
Luke’s
A strong, talented staff is at the heart of St.
Luke’s Health System.
We are the state’s largest employer with more than 15,000 employees and a medical staff of more than 1,800 physicians and advanced practice providers.
We’re proud of our people who deliver skilled, compassionate care every day, and are looking to add dedicated individuals who will continue this same tradition of excellence.
*St.
Luke’s is an equal opportunity employer and does not discriminate against any person on the basis of race, religion, color, gender, gender identity, sexual orientation, age, national origin, disability, veteran status, or any other status or condition protected by law.
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