Clinical Research Coordinator
Location: New Brunswick
Posted on: May 10, 2022
Job Description Overview Vitalief is a fast growing, ---best of
breed--- Clinical Trial Solutions Company. We are seeking talented
and ambitious Clinical Research Coordinators to join our
exceptional team, that has a passion for establishing credibility
with our clients by supporting our clients in planning and
execution of successful clinical trials. Every trial is different
and requires a solution that will optimize outcomes. Our approach
explores innovative ways of delivering services in a distributed
model that can support both decentralized and centralized trials.
If you are interested in being part of a culture that includes the
ability to have a voice challenging the status quo with novel
thinking, flexible work environment, transparent and open
communications, career pathing, and a variable incentive / reward
system, then we want to speak with you Note: Work is 100% on-site
in New Brunswick, NJ, with the potential for hybrid (part-time
on-site / part-time remote) work. Full time employment and
part-time employment options are available with Vitalief.
Responsibilities: This is a non-nurse position Under the direct
supervision of the Nurse Manager of Clinical Research Center (CRC),
will assist with subject recruitment, consenting, data entry, and
other clinical trial activities of the CRC. Preparation of
documents for submission to the Institutional Review Board (IRB),
Continuing Reviews, submission of Amendments and Modifications.
Assist in all aspects of CRC protocols. Prepares, manages and
completes all aspects of regulatory document submission to
pharmaceutical companies and clinical research organizations.
Ensures that staff---s Health and Safety Training and Continuing
Education Records are current and up to date. Manages and prepares
regulatory submissions for Investigator initiated projects, INDs
and HUDs. Understands and adheres to our client---s compliance
standards as they appear in our client---s Corporate Compliance
Policy, Code of Conduct and Conflict of Interest Policy. Keeps
abreast of all pertinent federal, state and client---s regulations,
laws and policies as they presently exist and as they change or are
modified. Ensures that the staff are trained and evaluated on their
knowledge of and adherence to compliance policies and procedures
specific to their jobs. Required Skills: Minimum of one year of
experience in Clinical research as a Clinical Research Coordinator.
Must possess a considerable understanding of Good Clinical Practice
(GCP) guidelines. Must have a solid understanding of the consent
process and possess sound interpersonal skills in order to interact
with subjects in a clear and a confident manner. The ideal
candidate will have a clear understanding of Food & Drug
Administration (FDA), Office of Human Research Protection (OHRP),
and Health Insurance Portability & Accountability Act (HIPAA)
regulations. Must be capable of independent decision-making, and
multitasking. Must be able to thrive in a fast-paced environment
and able to work on multiple clinical trials concurrently. Must be
computer literate with proficiency and working knowledge of
database and reporting tools such as Microsoft Word, Excel and
PowerPoint. To be successful, the candidate must have excellent
organization, verbal and written communication and skills.
Association of Clinical Research Professional (ACRP) certification
or Society of Clinical Research Associates certification is a plus.
Any exposure to OnCore (Clinical Trials Management System), and/or
EPIC (Electronic Health Records system) is a plus. Bachelor---s
Degree required. LI-DNI Powered by JazzHR nH0IuvaTf1
Keywords: Vitalief, New Brunswick , Clinical Research Coordinator, Healthcare , New Brunswick, New Jersey
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