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Clinical Trials Specialist (Senior CRC)

Company: Vitalief Inc.
Location: New Brunswick
Posted on: May 9, 2022

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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