Clinical Research Associate

Clinical Research Associate

Work type: Remote Working, including travel

Travel: You will be required to travel every fortnight to conduct Clinical Study Site Management across our sites. We have sites based in Harlow, Oxford, Basingstoke, Norfolk and London.

You will need to hold a Full driving licence and a car.
Fuel & Over night accommodation expenses will be paid.

ASAP start - 12 months

Hours:  18.5

Hourly Pay Rate: £55 Ltd/ Umbrella

This role is Outside of IR35

Service Overview:

This individual will be responsible for managing clinical activities at study sites conducting studies for the Medical Devices group, as well as, fostering strong, productive relationships with colleagues within the Medical Devices Group.

Responsible for managing clinical study activities for multiple sites in single or several clinical projects. Oversees performance of appointed study sites, conducting company initiated clinical studies.  Responsible for the site visits, monitoring, communication, and deliverables for the assigned study sites.  Serves as a member of the clinical study team and is the liaison between the clinical study team and study site personnel for the specific clinical projects.

Key Job Activities:

Clinical Study Site Management Tasks:

• Ensures that all work related activities, and decisions embody the Johnson & Johnson Credo Values.
• Verify safety and well being of study subjects are maintained for assigned study sites.
• Support the operational execution of clinical trials and ensure collection of high quality, substantiated data.
• Execute clinical trials activities following established standard operating procedures, good clinical practices and regulatory requirements.
• Accountable for study site performance, and providing high quality data according to the overall project timeline.  
• Assist Clinical Operations staff and study site staff to quickly and effectively resolve issues. Responds to problems and assists in implementing corrective and preventive actions, if required.
• Verify Investigator Site Files at assigned study sites are maintained according to regulations and/or company requirements/procedures.
• Responsible for supporting patient recruitment and retention activities.
• Performs site visits and ensures study site is compliant with the study protocol and all Federal, State, local, and company regulations, policies and procedures.
• Assists with internal communication of important clinical data and events. 
• Support organisation of Investigator and other study training meetings, if required.
• Functions as a reliable, trusted resource of accurate, up-to-date study site status knowledge, as requested by key stakeholders.
• Understand business value of clinical projects and balances overall business objectives and functional needs.
• May be involved in other tasks to support Clinical Operations and Operating Company as needed.
• Support the implementation of new clinical systems/processes.
• Interface and collaborate with Investigators, IRBs/ECs, contractors/vendors, and company personnel as needed.

Administrative Tasks:

• Incumbent knows, understands, incorporates, and complies with all applicable laws and regulations relating to business activities, and Policies and Procedures of the Health Care Compliance
• Program and Code of Conduct.
• May be asked to provide additional support to Clinical Operations staff, as needed.

Education:

• A Bachelor Degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.
• Typically requires Bachelors degree with at least 2 years of relevant experience; Masters or PhD/MD/PharmD with at least 1 year of relevant experience.
• Previous clinical research experience required.
• Previous medical device monitoring or equivalent experience required.
• Requires understanding and application of regulations and standards applied in clinical research areas and medical devices/combination products.
• Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
• Clinical/medical background – a plus.

Knowledge

• Requires experience and knowledge working with computer systems (Microsoft Office – Excel, Word, and PowerPoint). 
• Demonstrated competencies in the following areas are required:
  Leadership 
• Written and verbal communications
• Presentation and influencing
• Strong organisational skills (e.g., able to manage multiple sub-projects and tasks simultaneously and consistently meet all associated deadlines).
   

Diversity, Equity & Inclusion:

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences

That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.