BE - Clinical Research Associate

You 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.

Your responsibilities and your Impact:

• 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 Clinical Operations and study site personnel for the specific clinical projects.

Clinical Study Site Management 95%

Other Administrative Activities 5%

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 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.

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.

Experience Required for Role

Essential:

• A Bachelor Degree is required, preferably a Bachelor of Science Degree inLife Science, Physical Science, Nursing or Biological Science.

• 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).

• Requires experience and knowledge working with computer systems (Microsoft Office ? Excel, Word, and Power Point).

Demonstrated competencies in the following areas are required:

• Leadership

• Written and verbal communications

• Strong organizational skills (e.g., able to manage multiple subprojects and tasks simultaneously and consistently meet all associated deadlines).

• Ability to travel up to 80% of time (Flanders)

• Fluent in Dutch and English.

Things to remember before applying for this role:

• We are looking to process the first round of applications within the next 2 working days.

• We do not accept applications via email.

If you are interested in this role please apply now! Make sure you fill out your application in full, your personal CV will be used for the recruiter’s reference only, they are not sent to Hiring Managers. Ensure all relevant information is included in your application! 

Thank you very much and we look forward to receiving your application.

Questions

If you would like some additional information about the role please contact: bdardenn@its.jnj.com (please note that 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 in Belgium 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”.