Johnson & Johnson
Senior Clinical Research Associate
Senior Clinical Research Associate
Location: Diegem, Belgium (Hybrid)
Duration of the contract: Until 31 December 2027
Hours per week: 40
Imagine your next project driving clinical excellence in electro cardiophysiology studies that transform patient care. In this role, you will be responsible for managing clinical study activities from initiation to close-out for multiple sites conducting company-initiated studies for the MedTech group. You will oversee site performance, foster productive relationships, and serve as the crucial liaison between the clinical study team and study site personnel to ensure the highest standards of data quality and patient safety.
roles and responsibilities
This role focuses heavily on Clinical Study Site Management (95%) along with key Administrative Activities (5%).
This will involve:
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 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 organization 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.
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.
how to succeed
To be successful in this position, you will have a strong foundation in on-site clinical research monitoring, strict adherence to GCP, and a solid understanding of medical device regulations.
You will also bring:
A Bachelor Degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.
At least 4 years of relevant on-site monitoring 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.
Must have good proficiency and be able to converse and read medical notes in English and Dutch.
French proficiency is preferred.
Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
Clinical/medical background – a plus.
Requires experience and knowledge working with computer systems (Microsoft Office – Excel, Word, and Power Point).
Demonstrated competencies in Leadership, Written and verbal communications, Presentation and influencing, and Strong organizational skills (e.g., able to manage multiple sub-projects and tasks simultaneously and consistently meet all associated deadlines).
Ability to travel up to 80% of time.
benefits
This role offers a very competitive hourly rate. This contract will run for until 31 December 2027.
you are welcome here
Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
about Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible.
For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalised.
application process
We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email.
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”.