BD (Becton, Dickinson and Company) Clinical Research Associate II in Sparks, Maryland
Job Description Summary
The purpose of the Clinical Research Associate II position is to provide Study Monitoring for clinical studies conducted by Corporate Clinical Development. Clinical studies may range from simulated use studies (employing a clinician to use the device in a simulated environment) to complex studies in human subjects and/or specimens that may include devices, in vitro diagnostics (IVDs), drugs, or drug/device combinations. The GCD supports all BD business units.
The Clinical Research Associate II serves as a study monitor for moderate to complex studies in compliance with Good Clinical Practices, and all National and Local Regulations. They may also perform the role of Lead Monitor on studies as required, and/or mentor a Study Monitor assigned to a project.
This individual will report directly to a GCD Study Monitoring Group Leader.
The primary responsibilities of this position are:
Serve as Study Monitor performing on-site and in-house monitoring activities
Assist with maintenance of the Trial Master File
Create study specific documentation
Effectively manage clinical study sites
Mentor Associates at the Associate Clinical Research Associate and Clinical Research Associate I level
Education and Experience:
Minimum of a Bachelor's degree required.
3-5 years of laboratory experience required.
Combination of education and experience in life sciences, technical, clinical trials, Regulatory Affairs, or Quality preferred.
Willingness to travel up to 50% of the time (domestic and International).
A clinical/medical/technical degree involving fewer than 4 years of study, such as an RN, RPh, Veterinary Technician/Technologist or Medical Technician/Technologist preferred.
Professional certification through one or more relevant associations (e.g., ACRP, SOCRA, RAPS) desirable.
Primary Work LocationUSA MD - Baltimore
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