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Cra Field Monitoring Eu (The Netherlands)

Posted on Dec. 25, 2024 by ENDOTRONIX

Kharmanli, Netherlands
N/A

Cra Field Monitoring Eu (The Netherlands)

WHO ARE WE?

Endotronix is a medical device company that aims to transform the treatment of heart failure, a chronic, progressive condition in which the heart is unable to pump enough blood to support the body. Our Cordella Heart Failure System (CHFS) includes proactive management tools for best practice care and detection of worsening heart failure. These easy-to-use tools improve patient quality of life and help to reduce hospital admissions thereby reducing health care costs. With our recent PMA approval from the FDA and acquisition by Edwards Lifesciences, we are growing our team – it’s a great time to join Endotronix!

WHAT YOU’LL DO

The Field Monitoring Clinical Research Associate will ensure trial patients' safety by assuring trials are conducted ethically and within regulatory compliance, data accuracy, and protocol adherence.

Field monitoring of studies and data collection for clinical trials, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements.
Provide oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Committees, Clinical Operations (e.g.Contracts), and recommend and develop process improvements.
Verify trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded according to Endotronix Standard Operating Procedures, ICH and GCP Guidelines.
Validate investigational device accountability by tracking the history of investigational devices from Endotronix to the field sites and through final disposition.
Assist with activities for evaluation and selection of investigative sites
Develop and deliver training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities.
Contribute to the development of informed consent forms, and case report forms.
Edit/amend informed consent documents.
Preparation of study specific tools (including communication tools such as newsletters, flyers etc.)
Assist with the organization and participate in investigational meetings, and site training representing assigned clinical trial(s)
Additional responsibilities and duties as assigned and commensurate with job level

WHAT YOU BRING TO THE TABLE

3+ years of sponsor, CRO, or research site experience
Familiarity with medical device regulations
Familiarity with clinical research in Cardiology
Understanding of GCP and ICH guidelines
Must be highly motivated, have excellent interpersonal and written communication skills, great desire to help others, composed under stress and well organized
Strong critical thinking and problem-solving skills
Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines.
Ability to maintain excellent working relationships with a broad range of internal and site study staff.
Ability to work well in a team environment but also independently on assigned tasks without significant oversight
Clinical research certification (ACRP or SoCRA clinical coordinator/ CRA certification) preferred
Detail and process oriented
Positive attitude and approach
Computer proficiency (MS Office - Word, Excel, Power Point and Internet skills}, aptitude for training
Must be willing and able to travel

EDUCATION

Bachelor’s Degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology.)

WHO YOU ARE

Relentlessly focused on data and hypothesis driven decision making to create the best experiences for ETX patients and customers
Someone with a bias for action and quick iteration as opposed to perfection
A quick learner, who is able to work independently, multitask, and drive your own projects
An effective communicator and collaborator who can synthesize insights from multiple stakeholders across business functions to deliver purpose-built insights, models and tools that provide easily interpretable and actionable results
A team player who can inspire teams to deliver together, embodying the idea that the whole is greater than the sum of the parts
Passionate about digital healthcare and leveraging Data to deliver innovative solutions at scale

WHAT WE’RE LIKE

Willing to have the “direct and honest conversation”. Not afraid to confront the facts (or be confronted) and develop a plan to move forward.
Competitive spirit and drive to win. Strong sense of initiative, internal motivation, and an unrelenting focus on results.
Openness to feedback and coaching with a strong orientation towards continual learning and improvement. Ability to solicit, accept and provide direct feedback without defensiveness.
Capacity to function in a highly complex company with ease and fluidity, while driving and influencing results.
Entrepreneurial, flexible, yet results focused.
High degree of intellectual curiosity, honesty, and capability.
Low ego and humble in spirit in spite of your track record of outstanding performance.

LIFE AT ENDOTRONIX

Our shared company values create a foundation of trust and collaboration. United in a common purpose, we excel at the task at hand to provide best-in-class medical technology and customer service to our patients and clinicians. And along the way we make sure to have a little fun, continue to grow and celebrate our successes.
We provide a competitive compensation package, comprehensive benefits including unlimited PTO, and an environment that will help you to thrive and succeed in your career.
Endotronix is an equal opportunity employer, and we are committed to providing equal employment opportunities to all persons without regard to race, creed, color, religion, national origin, gender, marital status, citizenship status, age, veteran status, or disability. We are passionately committed to building a diverse organization where all perspectives and cultures are celebrated.

Advertised until:
Jan. 24, 2025

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