AddressDescription
Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Clinical Research Associate. Remote work options may be considered on a case-by-case basis and if approved by the Company
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's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.
Reporting to the Lead Clinical Research Associate, 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.
Key Responsibilities:
· Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate reoccurrence throughout study phases
· 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
· 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 efficiencies 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
· 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.
· 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.
Qualifications
· Bachelor's Degree
· 3 years of previous field monitoring experience required
· Excellent written and verbal communication, presentation, interpersonal, and analytical skills required
· Proven expertise in MS Office Suite, including Word, Excel, Adobe
· 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 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
This job posting is anticipated to close on 3.11.2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $95,000 to $125,000. The Company maintains highly competitive, performance-based compensation programs. . Additional information can be found through the link below. For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits
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.
