Abiomed, part of Johnson & Johnson MedTech, is seeking an experienced, high caliber Field Clinical Specialist for the Texas & New Mexico area.
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
The Field Clinical Specialist will be responsible for outstanding clinical trial execution at Abiomed to optimize patient safety, trial enrollment, and data integrity. Collaborating cross-functionally with Abiomed stakeholders and leveraging strong relationships with clinical site personnel including physicians, nurses, and clinical research specialists, the Field Clinical Specialist supports site selection and startup, drives patient recruitment, ensures protocol and data compliance, provides technical support for clinical procedures, supports challenging technical/protocol troubleshooting scenarios, critical software or product testing, and site closeouts.
As a subject matter expert on clinical trial protocol and technologies, the Field Clinical Specialist acts a liaison between Abiomed and the medical community, constantly communicating important information to investigators and customers – and parlaying clinical trial experience, knowledge, and feedback (“Voice of Investigator”) to Abiomed cross-functional partners such as R&D, medical affairs, marketing, sales, and education.
JOB DUTIES
* Provide field support for clinical research related enrollment and procedures.
* Serve as a technology, protocol and clinical trial procedure expert and resource Abiomed stakeholders, physicians, and research personnel at the site.
* Develop and maintain knowledge of clinical sites in the assigned territory.
* Understand and assess investigators’ interests and qualifications.
* Identify appropriate investigators as defined by study-specific requirements and by the applicable regulatory code.
* Maintain open communication and relationships with key site personnel including the Principal Investigator, Research Coordinator, as well as regulatory and legal personnel.
* Proactively and critically examine ways to enhance overall clinical trial performance.
* Facilitate communication between clinical sites and other Abiomed clinical staff (e.g., CRA, study team, Contracts Associate), as needed.
* Manage the following aspects of study progress, including, but not limited to:
o Start Up
o Nominate, approach, and complete qualification processes including establishing
o site/sponsor expectations for study execution.
o Facilitate contract/budget escalations as part of the start-up process.
o Train facility staff regarding protocol requirements and technology.
o Develop site-specific strategies to promote appropriate patient enrollment.
o Identify site successes and challenges and assist in implementing troubleshooting techniques that promote study goal achievement.
o Provide ongoing feedback concerning all aspects of study progress, specifically enrollment and procedure related, for the purpose of developing and implementing strategies that will optimize patient safety and contribute to organizational and corporate goals/objectives.
o Provide support for all study-related aspects to research partners, including but not limited to the following questions: technical, protocol, standard of care, clinical trial reimbursement, etc.
* Responsible for product reporting and troubleshooting with customers and field personnel within the clinical research portfolio.
* Collaborate with and provide feedback to Clinical Scientists and study teams in the development of clinical study deliverables, such as protocol design, source documentation, work instructions, patient recruitment materials and product training.
* Identify and communicate best practices relevant to clinical trial execution.
* Seek opportunities to continue demonstrating and developing technical, research, and organizational leadership qualities.
* Collaborate with Clinical Affairs, Medical Affairs, R&D, marketing, and commercial teams to support and advance key projects.
* Serve as a scientific interface with healthcare professionals.
* Act as resource in corporate product education as it relates to investigative technologies, as necessary: development and review of training materials, presentations, regional and national product launches, and commercial field education.
* Develop collaborative cross-divisional team relationships.
* Transfers clinical trial knowledge and experience into meaningful input and feedback to cross functional partners in R&D, medical affairs, marketing, sales, and education.
* Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Qualifications
* Bachelor’s Degree in engineering, nursing, biological sciences, a related field, equivalent or related certification in cardiology.
* A minimum of 5 years of relevant clinical experience, with in-depth knowledge of cardiology, and related cardiovascular technologies is required.
* Direct patient support in Cath lab or operating room is a plus.
* Availability for emergent patient care required.
* Ability to work in a highly matrixed and geographically diverse business environment.
* Ability to leverage and/or engage others to accomplish projects.
* Advanced verbal and written communications with ability to effectively communicate at multiple levels in the organization;exceptional presentation and influence skills.
* Multitasks, prioritizes, and meets deadlines in timely manner.
* Strong organizational and follow-up skills, as well as attention to detail.
* Ability to travel approximately 70% – Texas & New Mexico areas.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
