Research Regulatory Specialist-Oncology Research
UCHealth in Colorado Springs, CO
- Industry: Healthcare - Physician - Oncology
- Type: Full Time
Develops and submits Study Institutional Review Board (IRB) documents for initial submissions, protocol amendments, and continuing reviews.
Work Schedule: Full Time Days
Prepares, maintains and updates regulatory binders for review by internal or external monitoring/auditing groups. Works with auditors and monitors to discuss regulatory issues at each visit.
Maintains FDA and GCP required regulatory documentation for individual site, studies, and sponsors.
Submits Adverse Event Reports and Protocol Deviations according to institutional review board and sponsor-specific reporting requirements. Works closely with sponsors and study teams on the preparation of regulatory documents and relevant regulatory issues
Ensures all regulatory documentation is compliant with Standard Operating Procedures (SOP's) for format and content.
Within scope of job, requires critical thinking skills, decisive judgement and the ability to work with minimal supervision. Must be able to work in a fast-paced environment and take appropriate action.
- Minimum Required Education: Bachelor's degree.
- Required Licensure/Certification: None required.
- Minimum Experience: 3 years of relevant experience.
- IF APPLICABLE: BLS through the American Heart Association or the American Red Cross CPR for the Professional Rescuer with card in-hand before start date. BLS or CPR card must be good through sixty days of hire. All life support certification cards must be issued by either the American Heart Association or the American Red Cross CPR for the Professional Rescuer. (American Red Cross for the Professional Rescuer is only good upon hire and all renewals will need to be through an American Heart Association sanctioned course.)
We believe in something different: a focus on the individuality of every person. In big ways and small, we exist to improve the extraordinary lives of all those we serve. As Colorados largest and most innovative health care system, we as a team deliver on the commitment to provide the best possible experience for our patients and their families. We foster a true human connection and give people the freedom to live extraordinary lives. A career at UCHealth is more than a job, its a passion.
Going beyond quality requires the perfect balance of talent, integrity, drive and intellectual curiosity. We are looking for individuals who recognize, like us, that the world of medicine is ever-changing and are motivated to do what is right, not what is easy. We support creativity and curiosity so that each of us can find the extraordinary qualities within ourselves. At UCHealth, well do everything in our power to make sure you grow and have a meaningful career. Theres no limits to your potential here.
Be Extraordinary. Join Us Today!
UCHealth recognizes and appreciates the rich array of talents and perspectives that equal employment and diversity can offer our institution. As an affirmative action/equal opportunity employer, UCHealth is committed to making all employment decisions based on valid requirements. No applicant shall be discriminated against in any terms, conditions or privileges of employment or otherwise be discriminated against because of the individuals race, creed, color, religion, gender, national origin or ancestry, age, mental or physical disability, sexual orientation, gender identity, transgender status, genetic information or veteran status. UCHealth does not discriminate against any qualified applicant with a disability as defined under the Americans with Disabilities Act and will make reasonable accommodations, when they do not impose an undue hardship on the organization.
Associated topics: ancmg, aoa, breast, cancer, hem onc, hematology, oncology, palliative, physician md do, thedacare
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