BD (Becton, Dickinson and Company) Clinical Research Associate (Remote) in Franklin Lakes, New Jersey
Job Description Summary
The Clinical Research Associate (CRA) is responsible for day-to-day operations necessary to deliver high-quality, compliant clinical trial data, and ensuring the protection of the rights, welfare, and safety of human subjects in BD-Sponsored research.
The CRA provides Site Management and Study Monitoring for clinical studies conducted by Global Clinical Development (GCD). CRAs with experience monitoring surgical and oncology studies are preferred for this current role. However, Clinical studies may range from simulated use studies (employing a patient or clinician to use the device in a simulated environment) to complex studies in human subjects and/or specimens from human subjects that may include drug/device combinations. GCD supports all BD business units.
The Clinical Research Associate will manage multiple sites and studies in compliance with Good Clinical Practices, and all applicable National and Local Regulations. The CRA is responsible for site training, regulatory document collection, tracking enrollment, and ensuring case report forms are accurate, complete, and verifiable against source documents. The CRA is expected to contribute to the development and improvement of company procedures, processes, and templates in support of BD’s efforts towards continuous quality improvement.
The primary responsibilities of the CRA are to:
Effectively manage clinical study sites
Perform on-site, remote and/or in-house monitoring activities during site selection and qualification, initiation, interim monitoring, and close-out
Complete on-time and thorough monitoring reports
The CRA may assist in Development of Clinical Monitoring Plan, monitoring tools, and / or other study related documents.
The CRA must have at least a Bachelor's degree; BSN is preferred. Two (2) to five(5) years of field monitoring, site coordinator,, and/or clinical research experience is required. Individuals with experience with surgical device or oncology studies are preferred. The individual is expected to have training and be proficient in the following regulations: 21CFR-11, 50, 54,56, 812, and 820-C, ICH-E6, ISO-14155. The CRA should be able to work with platforms such as: CTMS, EDC, EMR, eTMF, IVRS, Sharepoint.
The CRA's location may be remote. 30-70% of time requires travel, depending on project.
Primary Work Location
USA NJ - Franklin Lakes
USA MD - Sparks - 7 Loveton Circle
NA (United States of America)
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.