Clinical Trials Specialist (Senior Clinical Research Coordinator)

Why Vitalief?

Vitalief, a fast-growing, innovative Clinical Trial Solutions Company, is committed to identifying talented and passionate clinical research professionals to join our exceptional team as experts and active members of our clients' research efforts.

Our PEOPLE FIRST culture prioritizes personal and professional growth for OUR team. Although unconventional, we believe this is the right approach to attract and retain top clinical research talent. We offer the flexibility, growth, and professional support that the highly competitive clinical research industry demands.

None of this is possible without the drive and passion of our Vitalief team members. If you are interested in the clinical research profession and being part of a culture that includes:

• The ability to create and pursue multiple career paths
• Meaningful work in a flexible work environment
• An innovative culture that respects and encourages your voice
• Transparent leadership that invests in your career progression
• Variable incentive/reward system
• Mentor/mentee opportunities and support programs designed to help you achieve your professional goals

Then we want to speak with you!

Note: Work is 4 days per week on-site in Hamilton, NJ, and one day per week remote.

Responsibilities:

• Under the direct supervision of the Nurse Manager of Clinical Research Center (CRC), 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.
• Assists in all aspects of CRC protocols.
• Prepares, manages and completes all aspects of regulatory document submission to pharmaceutical companies and clinical research organizations.
• 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.

Required Skills:

• 3 to 5 years of experience in Clinical research as a Clinical Research Coordinator.
• Strong mentoring skills and experience overseeing junior level coordinators.
• Must have a solid understanding of the consent process and possess excellent interpersonal skills in order to interact with subjects in a clear and a confident manner.
• Considerable understanding of Good Clinical Practice (GCP) guidelines, Food & Drug Administration (FDA), Office of Human Research Protection (OHRP), and Health Insurance Portability & Accountability Act (HIPAA) regulations.
• Capable of independent decision-making, and able to thrive in a fast-paced environment working on multiple clinical trials concurrently.
• 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.

IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that requires all on-site resources such as prospective Vitalief consultants to provide proof that they are fully vaccinated for Covid-19; inoculated annually for Influenza; and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.

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