Johnson & Johnson Vision Care, a member of Johnson & Johnson's Family of Companies, is recruiting for a Clinical Compliance Specialist to be located in Jacksonville, Florida.
VISTAKON®, a division of Johnson & Johnson Vision Care, is a worldwide company with operations in the United States, Japan, Latin America, Asia-Pacific and Europe / Middle East / Africa regions. Research, innovation and new-product development are the focus of our organization. Since we introduced soft disposable contact lenses in 1988, no other manufacturer has matched the aggressive expansion of our wide-ranging ACUVUE® family of products. Our associates around the world are committed to expanding the ACUVUE® brand, and fortifying our position as the worldwide leader in the contact lens industry.
The Clinical Compliance Specialist serves as the liaison and coordinator for receipt and processing of clinical research requests including those for company-sponsored and investigator-initiated studies. The adminitstrator is responsible for prioritizing requests, answering questions regarding the review process, organizing and expediting the flow of the requests to the Clinical Research Review Committee (CRRC), and tracking the status and progress of each request. The Clinical Compliance Specialist is also responsible for updating and maintaining associated procedures and tools to ensure alignment with corporate and company policies.
The Clinical Compliance Specialist serves as the liaison and coordinator for external investigator applying Investigator Initiated Study (IIS). The Clinical Compliance Specialist will assist with administration of registration records for www.clinicaltrials.gov (CT.gov) to ensure timely updates and posting of results through PharmaCM in compliance with JJVCI, FDA and FDAAA policies and guidelines. The Clinical Compliance Specialist will support internal company clinical quality assurance audits and external regulatory inspections and respond to those audits and inspections including CAPA plans, training, and procedure modification and implementation. The Clinical Compliance Specialist will also support activities related to following operating procedures and policy for the Safety Review Committee.
• Reviews all clinical research and investigator initiated study requests for completeness and compliance with JJVC policies and procedures.
• Routes appropriate requests to the Clinical Research Review Committee.
• Tracks the status of all requests.
• Compiles, distributes and maintains CRRC meeting minutes.
• Maintains the processes, procedures, and tools to be compliant with J&J corporate and JJVC policies and recommends improvements.
• Maintains CRRC, Safety Review Committee, IIS application/communication, and CT.gov communication tools, such as SharePoint and internet sites.
• Support internal company clinical quality assurance audits and external regulatory inspections and respond to those audits and inspections. Qualifications
• A minimum of a Bachelors’ Degree is required¸ preferably in a Scientific or Technical Discipline.
• A minimum of 2+ years of experience in clinical research, regulatory, or related field required; 1+ years of experience in the health care compliance field is preferred.
• An understanding of the application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP) is required. Strong communication, organizational and interpersonal skills is required.
• Experience in the contact lens industry is an asset.
• This position may require up to 10% domestic travel and will be based in Jacksonville, Florida.
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LI NAPrimary Location
Johnson & Johnson Vision Care, Inc. (6094)Job Function
Clinical Research non-MD