The team is looking for a highly motivated Research Associate and/or Research Assistant that will be responsible for routine screening of compounds in various in vitro toxicology or ADME assays.

This position requires hands-on laboratory experience working with analytical techniques for testing of drug substance and drug product to provide phase appropriate analytical development in support of clinical programs to commercial registration and post approval improvements for company projects.

Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA) or equivalent certification, preferred. 5+ years of relevant experience as a clinical research associate or clinical research coordinator is required.

Clinical Research Associate - 00001J0C. + 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.

We're looking for aSenior Research Associate, working inPharmaceuticals and Medical Productsindustry in40 Landsdowne Street, Cambridge, Massachusetts, 02139, United States. Improving lives globally with 20+ years experience in clinical research and strategic resourcing.

Clinical research certification (ACRP or SoCRA clinical coordinator/ CRA certification) preferred. Reporting to the Manager, 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.

Clinical Research non-MD. 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.

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 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.

Validate investigational device accountability by tracking the history of investigational devices from Abiomed to the field sites and through final disposition. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.

Abiomed is an Equal Opportunity Employer committed to a diverse workforce. I Am Abiomed | I Am Heart Recovery | Patients First! 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.

Abiomed's "Patients First!" 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.

Strong understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise. 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.

The CRA should ensure compliance with international guidelines, local regulations and corporate policies and procedures. Our team focuses on future development of the Impella platform, including clinical studies, data science and new clinical and physiological applications.

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.

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.