Regulatory Specialist

Research department within GI office is seeking a full-time Regulatory Specialist. Regulatory Affairs is responsible for completing site submission documents, maintaining the Site Investigative File during the course of a clinical trial, writing SOPs and functioning as liaison with FDA/Regulatory Authorities and vendors.  Industry clinical research experience is preferred and hours are 8:30am – 5pm, M-F.

Duties and Responsibilities

• Performs In-house audits (monitoring) of clinical research studies for compliance to ICH/GCP guidelines
• Prepares site for any sponsor and regulatory audits/inspections
• Provides support to sponsor and regulatory authorities during any audits/inspections
• Creates, updates and trains staff on company standard operating procedures
• Collaborates with management to develop quality assurance systems and any corrective action plans necessary for operational improvement and site compliance
• Maintains documentation of quality systems for sponsor monitoring visits
• Creates, conducts and maintains training curriculum and documentation for all staff training to include GCP, SOP, HIPAA, OSHA, etc….
• Attends in-house sponsor study meetings, site initiation and study close out visits. 
• Attends sponsor investigator meetings as needed
• Oversees quality control checks (drug temperature monitoring and equipment calibrations to ensure site compliance
• Creates and maintains the new hire training curriculum and assists management in conducting the new hire training curriculum orientation
• Determine regulatory strategy, plan and coordinate documentation/data for submission to the Sponsor/CRO and or IRB
• Ensure compliance in regulatory requirements for clinical trials

• Maintain all staff curriculum vitae’s and licensure
• Track IRB approvals and renewals for clinical trials
• Send confidentiality agreements, and clinical trial agreements to Sponsor/CRO
• Collects, reviews, and tracks regulatory documents when required
• Explore recent developments in clinical trial regulations including FDA requirements
• Understand the most important legal aspects of clinical trials
• Achieve successful regulatory inspection
• Maintains Project Management documentation and tracking of new study start up activities
• Meet with Site monitors and assist with site monitoring visits as necessary
• Reviews all monitoring visit letters and reports to management.  Creates follow up monitoring letters to address outstanding queries
• Update IRB continuing reviews for current studies
• Complete all the documents needed in preparation for submission to the pharmaceutical sponsor and/or CRO.  Such documents include, but not limited to FDA1572, Financial Disclosures, Protocol Signature Page and other regulatory required documentation for study start up
• Ensure IRB approval is granted prior to providing Clinical Research Coordinators at study start up
• Report any and all action items to management in weekly reports/staff meetings
• Provide quality recommendations (based upon regulatory guidelines) to management for improved site operations
• Provide experienced oversight to clinical research staff in conducting and coordinating clinical study visits
• Track and maintain meeting minutes
• Document creation as needed

Qualifications

• Excellent oral and written communication skills
• Detail oriented
• Strong organizational skills
• Ability to work under pressure
• Demonstrates time management skills and ability to work toward deadlines
• Knowledge of ICH, GCP and FDA guidelines
• Knowledge of sponsor, IRB and FDA Inspections and have the ability to prepare for them
• Knowledge of clinical research processes and procedures
• Basic knowledge of computer skills in a variety of software environments (Microsoft Word, Excel, etc…)
• Strong interpersonal skills
• Ability to mentor and provide staff training as needed