Sr. Clinical Research Regulatory Coordinator
Full Time • Newport Beach, CA
Sr. Clinical Research Regulatory Coordinator needed in Newport Beach, CA
Location: Hospital in Newport Beach, CA 100% onsite, no remote available
Schedule Hours: 40 hrs a week
Hourly Rate: $40/hr
Required Skills & Experience:
-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.
-Ability to work in fast paced environments.
-FDA and IRB start up experience.
Location: Hospital in Newport Beach, CA 100% onsite, no remote available
Schedule Hours: 40 hrs a week
Hourly Rate: $40/hr
Required Skills & Experience:
-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.
-Ability to work in fast paced environments.
-FDA and IRB start up experience.
Preferred Skills & Experience:
-Working knowledge of NIH, and OHRP regulatory requirements and ICH GCP guidelines preferred.
Required Education: Bachelor's Degree
Key Qualifications:
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
Regarding department supporting: Cancer trials account for approx. 70% of trials. Also support GI, Cardiac, Diabetes and Neurology
Please apply online or email resume to: allison.argueta@huckeyehealthcare.com
-Working knowledge of NIH, and OHRP regulatory requirements and ICH GCP guidelines preferred.
Required Education: Bachelor's Degree
Key Qualifications:
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
Regarding department supporting: Cancer trials account for approx. 70% of trials. Also support GI, Cardiac, Diabetes and Neurology
Please apply online or email resume to: allison.argueta@huckeyehealthcare.com
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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