Research Regulatory Specialist – Not a Remote Position Position Available In Duval, Florida

Research Regulatory Specialist – Not a Remote Position Cancer Specialists of North Florida – 3.5

Jacksonville, FL Job Details Full-time Estimated:

$34.9K – $41.6K a year 1 day ago Qualifications Research Mid-level High school diploma or GED Clinical trials Full Job Description Cancer Specialists of North Florida is recruiting for an experienced Research Regulatory Specialist for our busy Central Business Office. This is not a remote position. The Research Regulatory Specialist works under the Clinical Research Manager to oversee the processing of regulatory requirements for the clinical trials and to ensure trial compliance with all applicable Federal regulations, ICH guidelines, and sponsor requirements. This position establishes and maintains relationships with agency representatives, sponsors, and research team members and communicates all pertinent changes, updates, and necessary documents accordingly. In addition to this, the Research Regulatory Specialist oversees and audits the maintenance of clinical trial filing and reviews and prepares responses to inquiries from regulatory authorities. Essential duties and responsibilities include the following: Oversees the collection, submission, tracking, expiration, and updates of all regulatory documents for all clinical trials ensuring compliance with the Food and Drug Administration and all internal regulations Establishes and maintains relationships with the regulatory agency representatives, sponsors, and research team members Reviews and prepares responses to inquiries from regulatory authorities and sponsors Communicates pertinent changes and updates to research staff and management Prepares outlines, summaries, status reports, graphs, charts, tables, and slides for distribution and communication to other departments Oversees and audits the maintenance of regulatory files for clinical trials to ensure all pertinent documentation is completed for submission to sponsors, institutional review boards (IRB), and regulatory agencies Responsible for the timely completion and submission of regulatory documents, including routine reports, renewals, and amendments Develops and maintains current regulatory knowledge and keeps abreast of regulatory procedures and changes Assist Research Manager with potential new studies being evaluated and ensure and timely startup from site selection to activation. Maintains inventory of clinical trial provided supplies and distributes to clinical sites. All other duties as assigned by research manager. Full-time Position, Monday –

Friday Location Address:

7751 Belfort Parkway, Jacksonville, FL 32256

Education and Experience:

High School Diploma or Equivalent Minimum of three years’ experience in medical related experience, preferably in research.

Compensation and Benefits:

Salary is commensurate with experience and qualifications Cancer Specialists of North Florida is an “EEO Employer” and “Drug Free Workplace”