Senior Regulatory Coordinator Clinical Research - Cerritos, United States - Oncology Institute Inc.

Description

Senior Regulatory CoordinatorResponsibilities:

Serve as the Regulatory Manager in the absence of the acting managerMaintains research practices using Good Clinical Practice (GCP) guidelines.

Assists with auditing trials (Review and Preparation)Reviews and Submits Protocol Deviations and SAEs to IRB.Works directly with monitor and completes requests.

Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs.

Multi-task and prioritize effectivelyOrganize multiple projects for efficiencyWork efficiently and complete tasks with a high degree of accuracyReview IRB Portals for new approvals.

File and maintain reg binder/e

• Reg.

Review DocuSign Portal and e

• File documents.

Prepare and complete the release of IND Safety reports for several trials.

Assist in FDA and Sponsor AuditsSkills & Abilities:
Knowledgeable of FDA and QA audit processes.
Strong interpersonal communication skills to interact with others effectively and diplomatically.
Strong writte n com munication skills, ability to compose correspondence and maintain large file system.
Typing and computer skill /ability including word-processing, use of spreadsheets, e-mail (PC, WORD, EXCEL, POWER POINT).


Education and Experience:

Four or more (4+) year s experience with regulatory document submission to central IRB for review, followed by document tracking and follow-up, with continuing review report and amendment submissions as needed.

Demonstrated experience with multi-study and multi-site clinical research activities.

Demonstrated knowledge and understanding of human research policies, regulations, procedures, and standards as according to HIPAA, IRB, FDA, ICH, and GCP guidelines.

Demonstrated knowledge of FDA and Sponsor regulatory requirements.
Bachelors Degree p referred#J-18808-Ljbffr