Regulatory Specialist
- Employer
- Center For Digestive Health
- Location
- Orlando, Florida
- Salary
- Salary based on experience + Medical/Vision and Dental benefits
- Posted
- May 12, 2021
- Closes
- Jul 11, 2021
- Ref
- Regulatory Specialist
- Industry
- Healthcare
- Category
- Administrative, Clerical, Communications, Healthcare, Research & Development
- Contract Type
- Permanent
- Hours
- Full Time
- Career Level
- Student (High School)
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