Regulatory Coordinator job in Sacramento, USA

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Publishing & Submissions, RA Intelligence

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a Regulatory Coordinator with a pharmaceutical company located in Sacramento, CA.

Job Responsibilities:

Supports all aspects of regulatory compliance for assigned studies.
Prepares regulatory documents, including descriptions of study and consent forms, for submission to the Institutional Review Board (IRB).
Tracks sponsor amendment notifications and submits amended protocols, consent forms and other regulatory documents to the IRB.
Report serious adverse events and reportable new information to the IRB in a timely manner according to federal, local and institutional guidelines.
Processes timely submissions of continuing review documents to the IRB.
Coordinates with study sponsors, investigators and the IRB to complete study closure activities.
Maintains current knowledge of Federal, State and institutional guidelines and requirements governing research.
Prepares for and participates in monitoring visits for clinical trials.
Prepares for and participates in quality assurance audits conducted by the sponsor, FDA, NCI, Cancer Center Quality Assurance Committee or other specially designated groups when requested

Skills and Requirements:

Knowledge and understanding of disease processes as applied to human clinical research.
Knowledge of clinical research trials regulations (e.g., Food and Drug Administration [FDA] and Office for Human Research Protections [OHRP]) is essential.
Knowledge of regulatory processes as well as a working knowledge of data management activities as applied to clinical trial coordination.
Knowledge of basic anatomy, medical terminology and ability to interpret physicians' notes, medical records, laboratory and scan results.
Working knowledge with Microsoft Office Suite: Word, Excel, Outlook, Access, etc.

If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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