Johnson & Johnson Careers
CRA Resource Associate, U.S.
Requisition ID: 1741190809
Medical Devices a division of Johnson & Johnson's Family of Companies is recruiting for a CRA Resource located in Cincinnati, OH, Somerville, NJ and will consider remote and other locations.
The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.
On behalf of the Medical Device Group, this associate is responsible, to support the CRA Resource Manager – by coordinating and tracking of monitoring and site management work performed by the monitoring resources. Responsibilities include:
- Support CRA Resource Staff Specialist in resource planning and allocation of functionally sourced staff and contractors.
Assist in tracking of CRA workload and deliverables.
- Supports efforts to ensure efficient use of functional resources to provide efficient and high quality deliverables.
- Provide guidance and advice to Clinical Research Associates on company procedures and regulatory authority requirements.
- Assists in coordination of training of Clinical Research Associates ensuring updates on specific requirements.
- May perform accompanied site visits to assess and ensure quality and efficiency of Clinical Research Associates.
- May perform site monitoring and associated activities as needed to support trial activities within the Medical Device Group.
- Support CRA Resource Leader in the maintenance of quality standards, especially in monitoring and site management activities, using functional sourced staff.
- May participate in project management meetings and provide an overview of monitoring resources quality and workload on a regular basis.
- Provide internal communication of important clinical data and events.
Facilitate and manage study start-up as directed to ensure responsive and efficient process: site qualification, clinical trial agreements and budget negotiation, IRB/EC submissions and approvals, and site initiation/training
Develop and maintain good working relationships and communication with investigational sites and vendors
- Participate in departmental initiatives aimed at improving process and efficiency, in particular for the improvement of local process.
- Responsible for ensuring personal and company compliance with all Federal, State, local, and company regulations, policies and procedures for Health, Safety, and Environmental compliance.
- May be involved in other tasks to support Clinical R&D Operations and Franchise Clinical R&D, as needed.
- Solid knowledge of monitoring and site management processes.
- Knowledge of current clinical regulations, standards and good clinical practices
- Written and Verbal Communications
Good presentation skills and effectively influencing of others
Leadership required in alignment with J&J Leadership Imperatives: Connect, Shape, Lead and Deliver.
- Connect – partner and create strong relationships with key internal and external stakeholders, including US CTM/CTLs across the CoE as well as the resources providers and vendors to create a strong and productive partnership;
- Shape – through efficient use of resources shape the way clinical monitoring is conducted and resources are utilized;
- Lead – Take ownership for development of self and engage in transparent and constructive conversations Deliver - ensure all sponsored studies have appropriately qualified site monitors and track their activities to ensure all deliverables are met on time and in compliance to SOPs and regulations
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
- Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
- Performs other related duties as required.
Minimum Bachelors degree is required. A minimum of 4 years of relevant experience (or equivalent) required; Master’s with 3 years or PhD/MD/PharmD with 1 years of relevant experience preferred. Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
Requires understanding and application of US regulations and standards applied in clinical areas and medical devices/combination products is required.
Clinical/medical background is preferred.
Requires at least 2 years of monitoring experience (medical device and pharma a plus, CRO monitoring experience – a plus)
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability
North America-United States-New Jersey-Somerville
Medical Device Business Services, Inc (6029)
Clinical Trial Administration