Sr Clinical Research Associate

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at https://www.jnj.com/.

Abiomed, part of Johnson & Johnson Medtech companies is recruiting for a Sr Clinical Research Associate, located anywhere in the United States.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.

Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.

Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve.

Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

Reporting to the manager of clinical research associates, the person in this role is responsible for the management of day-to- day aspects of investigational site activities on assigned clinical trials.

The Clinical Research Associate should ensure compliance with international guidelines, local regulations and corporate policies and procedures.

Successful candidates will be forward thinking, anticipate needs and be able to work well in a fast-paced environment, either independently or as part of a collaborative team.

This person will be fully engaged and busy from the first day and we guarantee there will never be a dull moment.

Our team focuses on future development of the Impella platform, including clinical studies, data science and new clinical and physiological applications.
Key Responsibilities:


* Study start-up and study conduct activities including drafting ICF study specific template and TMF plan, approving study specific essential documents list, managing, and communicating the status of study progress and activities.


* Partner with cross-functional team (e.g., clinical data management, medical teams) with query management, data reviews and resolution.


* Provide coaching and training to junior employees.


* Lead in the investigation of all discrepancies in study documentation, by applying clinical protocol knowledge and GCP and develop processes to mitigate reoccurrence throughout study phases.


* Lead in assessing current and new processes, identifying opportunities and implementing so...