Abiomed is an innovative medical device business with an inspiring mission "Patients First," and a unique guiding company principle " Recovering hearts. Saving lives." With more than 2,000 employees, Abiomed is one of the fastest growing medical technology businesses in the world with corporate headquarters in Danvers, USA, and locations in Aachen and Berlin, Germany, Tokyo, Japan, and Singapore. Abiomed is part of Johnson & Johnson MedTech.

Abiomed is an employer with attractive working conditions and an appreciative corporate culture that focuses on the needs of its employees. Abiomed inspires and retains exceptional talent through collaboration, passion and continuous development.

Abiomed is recruiting for a

The Lead Clinical Research Associate (CRA) (m/f/d)

Location: Aachen

The Lead Clinical Research Associate (CRA) (m/f/d) is responsible for the management of day-to-day aspects of investigational site activities on assigned clinical trials. The Lead CRA should ensure compliance with international guidelines, local regulations and corporate policies and procedures. The Lead CRA is forward thinking, anticipating needs and able to work well in a fast-paced environment, either independently or as part of a collaborative team.

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• Study start-up and study conduct activities including, approving study specific essential documents list, managing and communicating the status of study progress and activities \n
• Partner with cross-functional team (e.g., clinical data management, medical teams) with query management, data reviews and resolution. \n
• 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 \n
• Lead in assessing current and new processes, identifying opportunities and implementing solutions to improve efficiencies within and across related functional areas \n
• 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 \n
• 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. \n
• 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 \n
• Manage monitoring progress of contract & CRO CRAs for respective sites. \n
• Develop and deliver technical training on GCPs, protocols, database, compliance, device \n
• 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. \n
• Oversee clinical trial conduct including management of metrics (e.g., dashboard), compliance, protocol deviations, and data entry cadence \n
• Provide input on strategic direction on field monitoring of studies and data collection for clinical trials with increased volume and complexity (e.g., KOL site), act as a Core Team lead, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/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) and regulatory requirements \n
• Oversee clinical trial conduct including management of metrics (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. \n
• Contribute to the development of clinical protocols, informed consent forms, and case report forms. Also contribute to team projects. \n
• Validate investigational device accountability by tracking the history of investigational devices from Abiomed to the field sites and through final disposition. \n
• 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. \n
• Edit/amend informed consent documents. \n

QUALIFICATIONS

Education: Bachelor\xe2\x80\x99s Degree or equivalent in relevant field

Work Experience: 5+ years of previous field monitoring experience (medical device and/or clinical experience)

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]