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Clinical Research Regulatory Specialist

3 months ago

Ocala, United States Renstar Medical Research Full time
Job DescriptionJob Description

Job Summary:

As a Regulatory Specialist at Renstar you will play a critical role for start-up, maintenance, and close-out activities of Clinical Trials. This role requires a meticulous attention to detail, organizational skills, and a commitment to maintaining the highest standards of document management. The Regulatory Specialist responsibilities will include, but are not limited to:

 

·        Preparing, maintaining, and updating regulatory/eRegulatory binders for review by internal or external monitoring/auditing groups. Meeting with auditors and monitors to discuss regulatory findings during their visits. 

·        Updating CVs, Medical Licenses, training certificates as needed

·        Adding and removing staff from studies as needed

·        Documenting staff training and updating logs as needed.

·        Notify staff and Director of upcoming training expiration dates.

·        Managing the archiving of closed studies according to SOPs

·        Maintains understanding of the professional guidelines and code of ethics related to clinical research.

·        Maintains compliance with Good Clinical Practice (GCP) guidelines, patient confidentiality (HIPAA) and any other applicable laws.

·        Responsible for study completion processes including study closeout, reporting, and archiving of hard copy and eRegulatory study files, ensuring completeness and continuity of all study documentation, and assuring proper archiving of appropriate/required documentation.

·        Identifies and communicates important regulatory issues or problem areas to supervisor.

·        Performs other duties as assigned or directed to meet the goals of the department.

 

Qualifications and Skills:

Strong organizational and time management skills.

Excellent attention to detail and accuracy.

Effective and professional oral and written communication skills.

 Knowledge of relevant regulatory standards and compliance a plus

 Works well with others