Clinical Research Associate I 6/3/2020
JOB DESCRIPTIONAPPLY 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.
Patients First | Innovation | Winning Culture | Heart Recovery
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 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.
* Participate in study start-up activities (e.g., tracking site readiness, communication with clinical trial sites about planning and logistics of site qualification visit and site initiation visit)
* 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
* Investigate discrepancies and participate in the development of processes to minimize possibility of recurrence during study conduct and closeout
* Assist in identifying opportunities and proposing solutions to improve efficiencies within and across related functional areas
* Participate in 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.
* Participate in 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.
* 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.
* 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/Clinical Operations (e.g. Contracts), and recommend and develop process improvements.
* Contribute with development and delivery of trainings; GCPs, protocols, and database, compliance, device accountability, and adverse event reporting.
* Edit/amend informed consent documents.
* Bachelor's Degree or equivalent in Life Sciences or related field with 1 year previous field monitoring experience required or
* 3 years equivalent learning in a working environment with hands-on clinical research experience encompassing all aspects of the clinical process, including 1) Cardiovascular device trials; and 2) Cath lab, operating room and/or intensive care unit familiarity required
* Excellent written and verbal communication, presentation, interpersonal, and analytical skills required
* Good 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
* Good computer skills in MS Office Suite, including Word, Excel, Adobe
* Experience with electronic data capture preferred
* Good written and verbal communication skills and interpersonal relationship skills
* Clinical research certification (ACRP or SoCRA clinical coordinator/ CRA certification) preferred
* Ability to travel up to 65% 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.