Regulatory Coordinator

Description

About Us:

Each of Cen Exel’s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability.

We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.

Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, Cen Exel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.

Job Summary:

With moderate oversight the Regulatory Coordinator I is responsible for the preparation, organization and implementation of regulatory research documents such as pre-study activities, initiation, execution, and reporting on the various status of research tasks in accordance with FDA guidelines, ICH GCP and SOPs. Maintain regulatory documents in accordance with applicable regulations and coordinate required investigator and study staff training.

Essential

Responsibilities and Duties:

• Collects, prepares, and submits documentation to various sponsors/CROs during study start-up, including:
• Protocol amendments with respective signature pages
• FDA form 1572
• 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), Cen Exel 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.

Education/Experience/

Skills:

• Must be a high school graduate or have GED equivalency.
• 0-2 years of experience in clinical research regulatory affairs.
• 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,…