Sr. Regulatory Coordinator
Full Time • Newport Beach
Job Title: Sr. Regulatory Coordinator
Job Description:
-IRB application submissions, SAE filing, 1572 document completion, training log completion, familiar with site essential documents, editing of informed consents sponsor audit or even FDA audit experience could be a huge plus.
-*Cancer trials account for approx. 70% of trials. Also support GIm Cardiac, Diabetes and Neurology
Job Description:
-IRB application submissions, SAE filing, 1572 document completion, training log completion, familiar with site essential documents, editing of informed consents sponsor audit or even FDA audit experience could be a huge plus.
-*Cancer trials account for approx. 70% of trials. Also support GIm Cardiac, Diabetes and Neurology
**Please make sure you have the following required skills and experience before applying (only accepting qualified candidates)**:
-Five (5) years of regulatory documentation experience in clinical research required.
-Thirty (30) to fifty (50) clinical trials completed at minimum.
-Experience with opening trials, filing applications and submissions for Phase 1 trials.
-Healthcare exp. with mid-size private or larger institutions
-FDA and IRB start up experience.
-Working knowledge of NIH, and OHRP regulatory requirements and ICH GCP guidelines preferred.
-Exp submitting applications and submissions to IRB (Institution Review Board)
Education: MUST have a Bachelor's degree to qualify
Compensation: $40.00 per hour
If you are interested, please contact us at staffing@huckeyehealthcare.com or give us a call at 281-769-8184
Jot Type: Contract, onsite
-Five (5) years of regulatory documentation experience in clinical research required.
-Thirty (30) to fifty (50) clinical trials completed at minimum.
-Experience with opening trials, filing applications and submissions for Phase 1 trials.
-Healthcare exp. with mid-size private or larger institutions
-FDA and IRB start up experience.
-Working knowledge of NIH, and OHRP regulatory requirements and ICH GCP guidelines preferred.
-Exp submitting applications and submissions to IRB (Institution Review Board)
Education: MUST have a Bachelor's degree to qualify
Compensation: $40.00 per hour
If you are interested, please contact us at staffing@huckeyehealthcare.com or give us a call at 281-769-8184
Jot Type: Contract, onsite
Compensation: $40.00 per hour
About Us
We are dedicated to building a reputation for quality health care that will benefit the community.
Huckeye Home Health Care is accredited by the Community Health Accreditation Program (CHAP), licensed by the State of Texas, certified by Medicare and also certified as a historically underutilized business (HUB) in the State of Texas.
Huckeye Home Health Care is accredited by the Community Health Accreditation Program (CHAP), licensed by the State of Texas, certified by Medicare and also certified as a historically underutilized business (HUB) in the State of Texas.
Huckeye Home Health Care is dedicated to building a reputation for quality health care that will benefit the community. We are part of the neighborhood, your family and your home.
Our Mission Statement
Huckeye Home Health Care is committed to the execution of a health care system whereby clients have the option to stay in their own homes while preserving their health.
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