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CenExel · 4 days ago

Regulatory Specialist - Clinical Research

Anaheim, California, United States

Full-time

Onsite

Entry Level

$30/hr - $35/hr

1+ years exp

CenExel is a company specializing in Phase I to Phase IV clinical trials with a focus on quality and teamwork. The Regulatory Coordinator I will be responsible for the preparation and organization of regulatory research documents, maintaining compliance with FDA guidelines, and coordinating training for study staff.

Clinical TrialsHealth CarePharmaceutical

Responsibilities

Collects, prepares, and submits documentation to various sponsors/CROs during study start-up, including: Submission documents/approval, Protocol amendments with respective signature pages, Informed consent documents, FDA form 1572, Lab normal result documents, financial disclosure forms, Delegation of authority logs, Licenses, Reports

Logs (e.g., temperature logs, drug accountability logs, master subject logs, screening and enrollment logs, specimen logs, etc.)

Collects, prepares, and submits documentation to institutional review boards for all ongoing and new trials

Serve as a liaison between the IRB, site, and investigator

Obtain necessary signatures from investigators and staff

Maintains and tracks current staff credentials (i.e., CV, certifications, etc.)

Maintains and distributes new and revised regulatory documents to applicable site staff and applicable corporate teams

Refers necessary regulatory questions to Sr. Regulatory Coordinator, Regulatory Manager or Regional Regulatory Manager

Maintains regulatory documents for ongoing trials, and ensures all appropriate regulatory documents are archived at the conclusion of the study

Submits applicable subject facing documents for translations

Maintains current Clinical Conductor Regulatory information

Prepares appropriate reports for submission as required to the IRB including Serious Adverse Events (SAE’s), protocol deviations and other required reports

Completes onboarding of new Investigators, including CV creation, obtaining medical license, and training documents

Ensures the regulatory binder is ready for monitor review during monitor visits. Meets with monitor, as necessary

Assists with regulatory inspections and sponsor audits as necessary

Performs close-out duties including preparing the final report to the IRB and ensuring all original documents are filed in the regulatory binder. Ensures all appropriate regulatory documents are archived at the conclusion of the study

Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies

Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive

Qualification

Regulatory experienceClinical researchERegulatory systemsIRB portalsProblem-solvingComputer skillsInterpersonal skillsAttention to detailCommunication skillsOrganizational skills

Required

Must be a high school graduate or have GED equivalency

1+ years of regulatory experience in clinical research required

Demonstrated prioritization and organizational skills to efficiently and effectively, providing accurate information in a timely manner

Ability to prioritize workload to meet demands of PI, coordinators, sponsors, and IRBs

Demonstrated interpersonal skills to work with physicians, administrators, work colleagues, representatives from sponsors and others to achieve maximum efficiency in reaching and maintaining workplace goals in a professional manner

Ability to understand work may be delegated by more than one person, depending on the individual needs of the clinical study and to carry out job responsibilities as assigned in a timely manner

Computer skills using PC platform computers with proficiency in Excel and Word to enter data and generate correspondence accurately

Ability to learn and become proficient in eRegulatory systems, IRB portals, vendor portals and sponsor portals

A critical thinker with strong attention to detail and superb problem-solving abilities

Must be able to effectively communicate verbally and in writing