Clinical Trials Specialist (Senior CRC)
Company: Vitalief Inc.
Location: New Brunswick
Posted on: May 9, 2022
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Job Description:
Overview
Vitalief is a fast growing, "best of breed" Clinical Trial
Solutions Company. We are seeking talented and ambitious Clinical
Trials Specialists (Senior CRCs) 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 4 days per week on-site in New Brunswick, NJ, and one
day per week remote. 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:
3 to 5 years 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.
If interested in finding out more about opportunities with
Vitalief, please contact:
Glenn Murani
Director of Talent Acquisition
Vitalief
610-209-1083
glenn@vitalief.com
vitalief.com
Keywords: Vitalief Inc., New Brunswick , Clinical Trials Specialist (Senior CRC), Healthcare , New Brunswick, New Jersey
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