Clinical Research Associate
Company: millenniumsoft
Location: Franklin Lakes
Posted on: April 2, 2026
|
|
|
Job Description:
Position : Clinical Research Associate Location : Franklin
Lakes, NJ Duration : 12 months contract Start Time : 08:00 AM End
Time : 05.00 PM Total Hours/week : 40.00 Qualifications: The
Clinical Research Associate (CRA) is responsible for planning,
negotiating, conducting, monitoring, and reporting on clinical
trials. The CRA is responsible for protocol development, site
selection and qualification, preparing Informed Consent materials,
contracting, training, site monitoring, and study document
management. The CRA collaborates with data management and
statistics groups to ensure accuracy and integrity of study data.
The CRA is responsible for preparing reports of study results for
investigators and internal development teams, assisting in
preparation of regulatory submissions, and supporting publication
activities. The CRA will interface with appropriate internal
individuals to manage trials in order to meet business objectives
and timelines, provide clinical and technical support to product
development activities, support product launches, and/or conduct
post-market surveillance and evaluation activities.
Responsibilities : Responsible for planning, budgeting, executing,
and monitoring clinical evaluations of BD products to support
product development. Clinical evaluations may also be for
post-market surveillance studies, or claims extensions of existing
products. Provide product development teams and other functions
with technical and clinical expertise and support. Activities will
be performed in accordance with international, federal and/or local
regulations (FDA, ISO), Good Clinical Practices (GCPs), and
compliance with corporate and local quality policies and
procedures. Specific Responsibilities: Develop the study design and
protocol(s) Screen, select, and qualify principal investigators and
investigational sites Conduct negotiations of clinical site
agreements and contracts Ensure the compliance to all human subject
protection and privacy regulations, including developing Informed
Consent materials Develop time schedules and budgets necessary to
manage the clinical evaluations Coordinate and plan availability of
supplies and shipment of materials Train clinical evaluation
participants in study products and procedures. Monitor sites to
assure that the Protocol is understood and followed Collect,
review, analyze, and report data generated during clinical
evaluations in a timely manner, through interactions with Clinical
Database/Statistics Communicate results of data analysis to each
clinical center, project teams and applicable functions within BD,
and actively support the publication and presentation of results by
investigators Support the reporting of performance data to
regulatory authorities Assumes responsibility for occasional
special departmental projects Anticipate 10% to 25% travel
(primarily domestic; international travel a possibility
Keywords: millenniumsoft, Hoboken , Clinical Research Associate, Science, Research & Development , Franklin Lakes, New Jersey
