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 CRA 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.
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 solutions to improve efficiencies within and across related functional areas
Conduct reviews of documentation needed for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Abiomed internal SOPs, and US and OUS regulations
Prepare materials for steering and investigator meetings
Conduct site initiation visits; train site personnel on sponsor and regulatory requirements for study conduct; participate in and/or conduct site meetings and prepare site initiation visit reports and associated documentation.
Conduct site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with study
Assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices), PHI (Personal Health Information) and regulatory requirements.
Manage monitoring progress of contract & CRO CRAs for respective sites.
Develop and deliver technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities. Act as a mentor to new or junior level employees.
Provide oversight of and insight into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Boards, Contract, and Training, developing process improvements.
Contribute to the development of clinical protocols, informed consent forms, and case report forms. Also contribute to team projects.
Validate investigational device accountability by tracking the history of investigational devices from Abiomed to the field sites and through final disposition.
Verify trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded.
Edit/amend informed consent documents.
Bachelor's Degree in related field with 5 years of previous field monitoring experience required
Excellent written and verbal communication, presentation, interpersonal, and analytical skills required
Demonstrated problem-solving and critical thinking skills
Proven expertise in MS Office Suite, including Word, Excel, Adobe
Experience working in a medical device or regulated industry preferred
Experience with electronic data capture preferred
Clinical research certification (ACRP or SoCRA, Clinical Coordinator/CRA certification) preferred
Ability to travel up to 65% required
Internal Number: 5034
About Abiomed, Inc.
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 1,400 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.