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Senior Clinical Training & Education Specialist

Date:  Sep 23, 2021
Location: 

Danvers, MA, US

Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 1,700 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.

 

Patients First | Innovation | Winning Culture | Heart Recovery
 

 

 

Job Description :

 

The Senior Clinical Training & Education Specialist reports to the Associate Director, Clinical Operations and has a very visible role within Abiomed, as well as externally with our clinical sites and study vendors.  The Senior Clinical Training & Education Specialist will work closely with the leaders of the Clinical Research team and is responsible for developing and implementing technical and product training initiatives for clinical trial-related activities. This role is responsible for analyzing, developing, implementing, and ensuring the continuous improvement of clinical trial-related processes, systems and SOPs to ensure the accurate and consistent use of Abiomed’s products across all clinical trials. Such tasks will be completed in accordance with Good Clinical Practice (GCP) and FDA/EU/PMDA regulations.  This individual serves as a resource for mentoring, support and training for internal and external clinical staff with regards to medical device use, clinical-trial processes and outreach programs.

 

 

Primary Duties and Responsibilities:

  • Develop effective training/education tools, demonstrations, presentations, tutorials, videos, etc for clinical site personnel and other staff for the effective use of Abiomed technology.
  • Develop case studies and medical education modules to enhance training/education success.
  • Assess the effectiveness of, and continuously improve, the training/education curriculum, materials, tools, and programs, based upon trends in protocol compliance, enrollment, monitoring deviations and data quality. 
  • Actively assess adherence to training materials during clinical trial activities and adjust training/education programs and strategy as necessary within the clinical team and cross functionally.
  • Create processes and forums for sharing best practices and key clinical training objectives.
  • Educate and train physicians and site staff on technical matters related to investigational products and procedures through conducting and/or coordinating one-on-one ad hoc training sessions and in-service structured educational programs (i.e. lunch and learn series).
  • Ensure clinical trial team is properly trained and in compliance with company and/or CRO SOP’s, ICH GCP guidance, other US and international clinical regulatory requirements, and study protocols.
  • Interact with in-house quality, regulatory, product development, data management and upper management to identify educational/training needs within the company.
  • Provide oversight of subject data review conducted by the monitoring team, per study monitoring plans and provide additional training as needed, to ensure a high level of quality is maintained.
  • Conduct Remote Site Initiation Visits, as needed.
  • Conduct Co-Monitoring Visits, as needed.
  • Assist in the development of study start up kits to ensure study enrollment and study management objectives are met.
  • Assist Communications Manager with Newsletter, as needed.
  • Assist in the development and review of clinical protocols, informed consent forms, and case report forms, as needed.

 

 

 

 

Job Qualifications:

  • Bachelor's Degree in Cardiology related field, RN preferred
  • 5 years Cardiology, Cardiac Surgery background
  • Background in public speaking and education
  • Knowledge of FDA regulations, GCP, GCDMP and ICH guidelines required specifically as it relates to ensuring compliance with these regulations and guidelines for audit readiness
  • Experience working in a medical device or regulated industry Preferred
  • Other: Clinical research certification (ACRP or SoCRA clinical coordinator/ CRA certification) Preferred
  • Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills are required
  • Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery
  • Demonstrated problem-solving and critical thinking skills
  • Strong understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise
  • Understanding of medical device regulatory requirements and related documents
  • Ability to communicate and relate well with key opinion leaders and clinical personnel
  • Travel up to 25% required

 

 

 

 

Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.


Nearest Major Market: Boston