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22 days old

Regulatory Affairs Coordinator Level 11

Kelly Services
Denver, CO 80238
Regulatory Affairs Coordinator Level 1


Direct Hire-Full Benefits


Remote Role


50-60K (DOE)


Duties

1. Serves as regulatory contact person for Investigator-Initiated clinical research studies and meets with Principal Investigators as well as in-house staff for review of regulatory records.

2. Writes clear and accurate consent/ HIPAA documents.

3. Completes consents, applications and other required forms as per the applicable Institutional Review Board (IRB).

4. Submits complete and accurate clinical research applications to all required regulatory bodies for the conduct of clinical research at the Cancer Center. This may include, but is not limited to, the following:

a. Food and Drug Administration (FDA)

b. Office of Human Research Protections (OHRP)

c. Colorado Multiple Institutional Review Board (COMIRB)

d. Protocol Review and Monitoring System (PRMS)

e. Research Administration (U-RA)

f. Colorado Clinical Research Support Center (CRSC)

g. Institutional Biosafety Committee (IBC)

5. Completes and submits continuing reviews, amendments, and other protocol-specific documents.

6. Maintains regulatory documentation for Investigator-Initiated research studies for review by monitors and auditors including preparation for monitoring/auditing visits and resolution of queries.

7. Completes and submits accurate federal forms, consents, HIPAA Authorizations, and obtains required approvals specific to the Denver VA Medical Center as necessary.

8. Updates OnCore with regulatory documents and dates.

9. Serves as back up coverage during RAC absences.

10. Assists in document collection and site regulatory communication for multi-center clinical trials.

11. Assist principal investigators and clinical project manager(s) in the development of the protocol and subsequent amendments for investigator initiated trials to ensure standardization and adherence to the Cancer Center, FDA and GCP policies and guidelines for Investigator-Initiated and multi-center trials.

12. Compiles and submits study documents or progress reports to funding partners as required.

13. Updates OnCore with regulatory documentation


Minimum Requirements

Education: Bachelors Degree focused in biological, medical science or business such as Nursing, Biology, Public Health, Business Administration, Law, or related fields of study.


Experience: Two (2) or more years of research, regulatory, or compliance experience.

Substitution: Work experience in a related field can substitute for the Bachelors degree on a year for year basis. Additionally, an Associates Degree plus two (2) additional years of related work experience will substitute for the Bachelors degree.




**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

Categories

Posted: 2022-04-29 Expires: 2022-05-30

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Regulatory Affairs Coordinator Level 11

Kelly Services
Denver, CO 80238

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