BD (Becton, Dickinson and Company) Jobs

Job Information

BD (Becton, Dickinson and Company) Senior Clinical Research Associate (Remote) in Sparks, Maryland

Job Description Summary

The Senior Clinical Research Associate (S-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.

Job Description

The S-CRA reports to the CRA Manager, and 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 S-CRA will manage multiple sites and studies in compliance with Good Clinical Practices, and all applicable National and Local Regulations. The S-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 S-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 S-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

  • Oversee/lead study-specific contract monitoring resources

  • Manage monitoring programs for an entire business unit or large development program

  • Mentor Associate Clinical Research Associates and Clinical Research Associates

  • The S-CRA may assist or be responsible for Development of Clinical Monitoring Plan, monitoring tools, and / or other study related documents.

All GCD associates, regardless of role, are expected to share our commitment to making a difference in the lives of others as we advance the world of health. We embody BD Values daily through our actions.

Qualifications:

  • Bachelor's degree; BSN is preferred.

  • Five (5) to eight (8) 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 individuals 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 Sr. CRA should be able to work with platforms such as: CMTS, EDC, EMR, eTMF, IVRS, Sharepoint.

  • The Sr. CRA location may be remote. 30-70% of time requires travel, depending on project.

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.

#LI-PRO

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

DirectEmployers