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Clinical Compliance Specialist – Good Clinical Practices (GCP)


Johnson & Johnson Surgical Vision, part of the Johnson & Johnson Family of Companies, is currently recruiting for a Clinical Compliance Specialist – GCP to be located in Santa Ana, CA.

Johnson & Johnson Surgical Vision (“JJSV”) is focused on the discovery, development and commercialization of medical devices for cataract and refractive surgery. As a global cataract leader, JJSV provides intraocular lenses (both monofocal and premium IOLs) that are specially designed to provide optimized visual outcomes, phacoemulsification and femtosecond laser equipment to safely and efficiently remove cataracts and a full offering of surgical adjuncts, including sterile viscosurgical devices/solutions.

JJSV is the global market leader in the presbyopia correcting IOL marketplace and holds strong #2 positions in all other cataract surgery markets in which it competes. JJSV is also the global market leader in laser refractive surgery and provides excimer and femtosecond lasers and advanced diagnostic devices for corneal refractive surgery. JJSV provides its products in more than 150 countries (more than 60 with a direct sales presence) worldwide.

The Clinical Compliance Specialist is responsible for ensuring that all clinical R&D activities are conducted in compliance with GCP and J&J Health Care Compliance Policies.

The Clinical Compliance Specialist will:

• Support internal and external GCP audits and CAPAs to include but not limited to: acting as a liason between internal auditors, CAPA Management Team and Clinical R&D personnel, consulting with Clinical R&D personnel to ensure appropriate remediation activities are identified, and tracking the progress of all CAPA and audit deliverables to ensure on-time completion.
• 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.
• Facilitate the receipt and processing of Healthcare Compliance (HCC) review requests in support of clinical research and global marketing activities.
• Provide administrative support for all trial registration activities to include: drafting the protocol registration, liasing with appropriate internal personnel to ensure the protocol registration follows applicable standards and guidelines, ensuring on-time submission of protocol registration the registry, and collaborating with the study personnel to ensure results are submitted to the registry in compliance with the applicable standards (i.e. Final Rule for FDAAA 801)
• 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.
• Perform other related duties as assigned by management

Qualifications
• Bachelor's Degree or equivalent experience required.
• A minimum of 5 years clinical research experience is required.
• A minimum of 2 years experience in the health care compliance field is preferred.
• Understanding and working knowledge of regulations and standards applied in clinical areas, medical devices and/or pharmaceutical products is required (i.e. ISO 14155 and ICH E6).
• Proficiency in Microsoft Office, including MS Project, Visio, and Excel software is required.
• Up to 10% of domestic travel is required.

Primary Location
United States-California-Santa Ana
Organization
AMO US Holdings, Inc.. (6234)
Job Function
Clinical Data Management
Requisition ID
8943180415