Clinical Trial Resource Associate - Remote
You must be UK based to apply for this role.
Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
On behalf of the Medical Device Group, this associate is responsible to support the CRA Resource Manager – by coordinating and tracking monitoring and site management work performed by the monitoring resource.
Duties and Responsibilities:
- Support CRA Resource Leader 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 ResourceManager 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.
Functional and Technical Competencies:
- Strong skills and demonstrated competencies in the following areas are required:
- 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
Professional Experience Required:
- Requires understanding and application of EMEA regulations and standards applied in clinical areas and medical devices/combination products.
- Clinical/medical background - a plus.
- Requires at least 2 years of monitoring experience (medical device and pharma a plus, CRO monitoring experience – a plus)
- Minimum Bachelors/University degree or equivalent required. 4-6 years of relevant experience (or equivalent) required; Master’s with 3 years or. Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
In return for this role you will receive a very competitive hourly rate. A minimum 12 month contract & an opportunity to work with a Global Leader within the Pharmaceutical sector, Johnson & Johnson.
Please Note: This role is INSIDE IR35. Pay rate for this role will depend on how you are paid (PAYE or Umbrella options)
If you are interested in this role please apply now, or for more information contact Tabitha.Crabtree@randstadsourceright.co.uk
Please Note: We will process the first round of application within the next 2 days so please be quick to apply!