- Entry level
- No Education
- Salary to negotiate
Johnson & Johnson Vision is recruiting for a Senior Clinical Compliance Specialist to be located in Jacksonville, FL.
At Johnson & Johnson Vision, we have a bold ambition: to change the trajectory of eye health. That’s why, through our operating companies, we’ve developed solutions for every stage of life—to help people see better, connect better and live better. We partner with eye care professionals to provide some of the world’s leading products and technologies to address refractive error, cataracts, dry eye, and beyond. We are committed to using our reach and size for good and strive to put quality eye care within reach of everyone, everywhere. Visit us at www.jjvision.com. Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn.
The Senior Clinical Compliance Specialist is responsible for ensuring that all clinical R&D activities are conducted in compliance with Good Clinical Practices (GCP) and J&J Health Care Compliance Policies.
They may support internal and external GCP audits and coordinate CAPAs to include but not limited to: acting as a liaison between internal auditors, CAPA Management Team and Clinical Operations personnel, consulting with Clinical Operations personnel to ensure appropriate remediation activities are identified, and tracking the progress of all CAPA and audit deliverables to ensure on-time completion.
The Senior Clinical Compliance Specialist may also serve as the administrator for the Clinical Research Review Committee (CRRC) to include: receipt and processing of company sponsored or Investigator Initiated Studies (IIS) application requests for CRRC review, prioritizing application requests, answering questions regarding the review process, organizing and expediting the flow of the requests to the CRRC, tracking the status and progress of each request, and providing additional administrative support to the CRRC Chairperson.
This person may facilitate and manage the receipt and processing of Healthcare Compliance (HCC) review requests in support of clinical research and global marketing activities. They will directly responsible for: answering questions regarding the documentation review and submission process, organizing and expediting the flow of requests, and tracking the status and progress of each request. They will also be responsible for all due diligence activities including recertifications.
The Senior Clinical Compliance Specialist may act as administrator for registering applicable clinical trials to the appropriate clinical registries (i.e. ClinicalTrials.gov) for protocol registrations and results submissions, including: drafting the protocol registration by liasing with appropriate internal personnel to ensure the protocol registration follows appropriate regulations (i.e. Final Rule for FDAAA 801), ensuring on-time submission of protocol registration to the clinical registries, and ensuring on-time results and responses to the clinical registries by collaborating with the designated study personnels in compliance with the regulations.
They may perform quality review of trial master file (TMF) to ensure compliance with the regulations for inspection by health authorities (including BIMO inspections) and work in collaboration with the study team to ensure file readiness and provide technical support in preparation for site and incoming audits. Also, they will adhere to environmental policy, procedures, and supports department environmental objectives.
Manage and coordinate Clinical Affairs CAPA and Audit deliverables to include: tracking to completion, trending, ensuring appropriate remediation activities are identified, and acting as a liaison between Clinical Operations personnel and the J&J Vision Quality organization
Coordinate activities of the Clinical Research Review Committee
Provide support and guidance for Investigator Initiated Studies to include: tracking requests, providing application materials to prospective applicants, submitting requests for review to the CRRC, and ensuring compliance with the J&J IIS policy
Prepare, review, and approve transactions in PRIZMA, and Healthcare Clinical R&D documentation for completeness and compliance with JJV policies and procedures. Ensure that payments are consistent with Fair Market Value and that the transactions are compliant with J&J Health Care Compliance policies
Manage training of vendors, Third Party Intermediaries, and Investigators on J&J
About the company
If you’re thinking about taking your career to a place where you can be seen for the talent you bring to your work, where you’ll have a chance to be the driver of your own career, and where others share your passion for caring and success, then we invite you to explore Johnson & Johnson. BE VITAL in your career and make a unique mark. Join the approximately 129,000 men and women who work within our companies and touch the lives of more than a billion people around the world every day.