Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.
I Am Abiomed | I Am Heart Recovery | Patients First!
We are seeking an experienced, high caliber Field Clinical Specialist 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.
- 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 (https://e.g., CRA, study team, Contracts Associate), as needed.
- Manage the following aspects of study progress, including, but not limited to:
- Start Up
- Nominate, approach, and complete qualification processes including establishing site/sponsor expectations for study execution.
- Facilitate contract/budget escalations as part of the start-up process.
Train facility staff regarding protocol requirements and technology.
- Develop site-specific strategies to promote appropriate patient enrollment.
Identify site successes and challenges and assist in implementing troubleshooting techniques that promote study goal achievement.
- 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.
- 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 https://U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.