Clinical Research Associate
Posted on: 2 Apr 2021
Franklin Lakes, NJ
Job Description
Job Description Summary
Job Description
The purpose of the Clinical Research Associate 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 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 CRA Manager.
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 level.
Minimum Qualifications:
Education and Experience:
* Minimum of 3 years' experience in field monitoring.
* Willingness to travel up to 50% -70% of the time (domestic and International).
* Minimum of a Bachelor's Degree required.
* Ideal candidate has the option to work remote. (CRA will cover Northeast or Midwest region)
Assets:
* Combination of education and experience in life sciences, technical, clinical trials, Regulatory Affairs, or Quality preferred.
* Experience with EMR review and complex clinical trials strongly preferred.
* 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.
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
Becton, Dickinson and Company
Franklin Lakes, NJ
Becton, Dickinson and Company develops, manufactures, and sells medical supplies, devices, laboratory equipment, and diagnostic products worldwide. The company’s BD Medical segment offers peripheral IV and advanced peripheral catheters, central lines, acute dialysis catheters, vascular care and preparation products, needle-free IV connectors and extensions sets, IV fluids, closed-system drug transfer devices, hazardous drug detection, hypodermic syringes and needles, anesthesia needles and trays, enteral syringes, sharps disposal systems; infusion pumps and dedicated disposables, medication compounding workflow systems, automated medication dispensing, automated supply management systems, medication inventory optimization and tracking systems; syringes, pen needles, and other products for diabetes care; and prefillable drug delivery systems.
Its BD Life Sciences segment provides specimen and blood collection products and systems; automated blood and tuberculosis culturing, molecular testing, microorganism identification and drug susceptibility, and liquid-based cytology systems, as well as rapid diagnostic assays, microbiology laboratory automation products, and plated media products; and fluorescence-activated cell sorters and analyzers, monoclonal antibodies and kits, reagent systems, bench-side solutions, and molecular indexing and next-generation sequencing sample preparation products, as well as clinical oncology, immunological, and transplantation diagnostic/monitoring reagents and analyzers.
The company’s BD Interventional segment offers hernia and soft tissue repair, biological and bioresorbable grafts, biosurgery, and other surgical products; surgical infection prevention, thoracic and abdominal drainage, and surgical and laparoscopic instrumentation products; peripheral intervention products; and urology and critical care products. Becton, Dickinson and Company was founded in 1897 and is based in Franklin Lakes, New Jersey.
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IndustryManufacturing
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No. of Employees76,032
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Website
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Jobs Posted597
