JOB TITLE –Regulatory Affairs Specialist

GENERAL SUMMARY OF DUTIES – Primary responsibilities include managing and planning regulatory affairs compliance for industry sponsors and/or sites in networks.   This position will work closely with the regulatory affairs management, department director and/or primary investigators to ensure compliance, preparing for auditing activities while meeting strict deadlines.

DUTIES INCLUDE BUT ARE NOT LIMITED TO:

* Establishes and maintains a document management system for regulatory paper and electronic files.

* Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks.  Ensures all regulatory documentation is compliant with local Standard Operating   Procedures (SOP’s) for format and content.

* Maintains updated physician credentials for network participants and other critical documentation ensuring compliance.

* Modify and/or develop informed consent forms and updates and manages protocol and consent form modifications or amendments in compliance with IRB policy and HIPAA.

* Organizes and coordinates IRB documentation for trials.

* Assist any internal or external audit team with any regulatory related issues.

* Apprises Regulatory Affairs Manager and Network Management, if applicable, of all study and site-specific regulatory issues for guidance and follow through.

* Archives study specific regulatory documentation and correspondence.

* Attending network meetings, conference calls and monthly staff meetings as appropriate.

* Participating in educational activities and programs.

* Maintaining strictest confidentiality.

* Performing related work as required.

* Practice and adhere to the “Code of Conduct” philosophy and “Mission and Value Statement”.

KNOWLEDGE, SKILLS, & ABILITIES – This position requires the following minimal requirements:

* Working knowledge of scientific and clinical research terminology is essential.

* Knowledge of IRB, FDA and GCP guidelines required.

* Ability to multi task and meet strict deadlines.

* Must have an exceptional level of attention to details in a fast paced environment.

* Strong interpersonal, communication, and organizational skills.

* High level of proficiency with MS Office products including Outlook, Word, and Excel.

EDUCATION

High school diploma or GED is required.

BS in nursing, pharmacy or other related science or combination of equivalent education and experience.

EXPERIENCE

Three years in healthcare, research or other science or research related field.

2 years clinical research experience.

CERTIFICATION/LICENSE – None