In-House CRA

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 Clinical Research Associate will take part in all areas of clinical trial management in North America. This includes, but is not limited to, day-to-day activities such as trial start-up, conduct, and closeout activities as well as supporting a range of activities on large multi-center studies, management of vendors and management of investigative sites with the support of the Clinical Operations team. Must be self-motivated, pro-active, and flexible. You will:

• Participate in the management of the completion of routine trial start-up, conduct, and close-out activities to industry and corporate standards.
• Assist with activities for evaluation and selection of investigative sites
• Conduct remote site monitoring support for Clinical trials, according to Endotronix Standard Operating Procedures, ICH and GCP Guidelines
• Assist clinical leadership with gathering data for internal metrics, and communication of trial status within and senior leadership team, and outside the trial team
• Ensure all internal trackers and systems are up-to-date
• Ensure that assigned clinical trial tasks are conducted in accordance with the protocol, country regulations, Good Clinical Practice regulations, and internal Standard Operating Procedures
• Participate in various tasks to support the Study Team/Management with any trial related activities in all phases of the conduct of the clinical trial
• Work closely with fellow in-house CRAs on the completion of tasks.
• Preparation of study specific tools (including communication tools such as newsletters, flyers etc.)
• Oversee internal folders to ensure actively current and up-to-date.
• Oversee Endotronix-specific items required to be in trial specific TMF including, as/if appropriate, site regulatory document and legal document tracking and archiving throughout the duration of the clinical trial in accordance with SOPs, GCP and ICH guidelines
• Actively manage assigned study sites to ensure prescreening/screening updates are provided.
• Ensure assigned study sites have sufficient supplies and investigational product for screening and implanting at study sites.
• Act as sponsor advocate for assigned study sites, ensuring all questions are answered and sites are actively enrolling.
• 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
• 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.