The Abiomed Clinical Research Associate (CRA) 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.
• Perform study start-up and conduct activities including ICF review that meets regulatory requirements, creating study specific essential document lists, managing and communicating the status of study progress and activities • Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate reoccurrence throughout study phases • 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 • Assess current processes, identify opportunities and propose solutions to improve process efficiency within and across related functional areas •Partner with cross-functional team (e.g., clinical data management, medical teams) with query management, data reviews and resolution •Conducts site initiation visits; trains site personnel on sponsor and regulatory requirements for study conduct; participates in and/or conducts site meetings and prepares site initiation visit reports and associated documentation. •Conducts 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. • Provide oversight of and insights 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 Committees, Clinical Operations (e.g. Contracts), and recommend and develop process improvements. • 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. • Validate investigational device accountability by tracking the history of investigational devices from Abiomed to the field sites and through final disposition. • Develop and deliver 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. • Contribute to the development of clinical protocols, informed consent forms, and case report forms. • Edit/amend informed consent documents.
• Moderate knowledge and understanding of Abiomed policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical studies • Moderate understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise • Moderate understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting • Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint and electronic data capturing system (e.g. iMedidata) • Excellent written and verbal communications skills • Advanced problem-solving skills • Ability to manage confidential information with discretion
Typical Education / Experience
• Bachelor's Degree or equivalent in related field with 3 years years of previous field monitoring experience Required or • Associate's Degree or equivalent in related field with 5 years years of previous field monitoring experience, quality assurance/control and regulatory compliance Required or • Other: with Experience working in a medical device or regulated industry Preferred • Other: with Experience with electronic data capture 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 documents, device accountability and adverse events reporting • Ability to communicate and relate well with key opinion leaders and clinical personnel
Travel up to 65% required
Internal Number: 5993
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.