Clinical Research Coordinator

2 weeks ago

Newark, United States Vitalief Full time
Job DescriptionJob Description

WHY VITALIEF?

Vitalief is a pioneering consultancy addressing the healthcare human capital epidemic.  Join us and help clients adapt to evolving requirements in the research and clinical trial industry with cutting-edge solutions. 

Reasons to Work for Vitalief:

  • Our PEOPLE FIRST culture prioritizes personal and professional growth for all Vitalief employees.
  • We give everyone a seat at the table – we encourage innovation.
  • We’re committed to our employees – you are encouraged and mentored by the talented Vitalief team to achieve full potential.
  • “Life/Work” balance that includes 20 PTO (Paid Time Off) days plus 9 paid Holidays annually.
  • Other benefits include Company paid life insurance and short / long term disability coverage; 401K retirement program; Robust healthcare plans to choose from.

Salary Range:  $60,000 to $70,000 annually

Work Location:  Work is 5 days per week on-site in Newark, NJ.

Job Responsibilities:

  • Under the direct supervision of the Nurse Manager of Clinical Research Center (CRC), you will be responsible for performing a wide variety of tasks to ensure successful Oncology related clinical trials.
  • Manage eligibility check lists, perform patient screening/consenting (informed consent), patient activation and managing patient care (patient retention).
  • Assist with monitoring patient visits.
  • Track deviations and documenting SAEs (serious adverse events).
  • Ship specimens to central labs or research labs.
  • Track data queries and prepare data for an upcoming audit.
  • Work collaboratively with all team members (i.e., physicians, nurses, hospital, and laboratory staff) to ensure that services are coordinated and delivered to patients in a timely manner.

Required Skills:

  • Minimum of 1 to 2 years of experience in Clinical Research as a Clinical Research Coordinator, with experience in patient recruiting/pre-screening/consenting/retention; activation; regulatory compliance and data management.
  • Bachelor’s Degree required.
  • Any experience in Oncology and/or working on complex clinical trials is a plus.
  • Ability to work on 12 to 15 concurrent trials – must have strong organizational and prioritization skills.
  • The keys to success in this role are your ability to demonstrate your versatility, “can do” attitude, and adaptability.
  • Considerable understanding of Good Clinical Practice (GCP) guidelines.
  • Experience in preparation of documents for submission to the Institutional Review Board (IRB), continuing reviews, and submission of amendments and modifications.
  • Experience ensuring Serious Adverse Events (SAEs) are completed and reported to the QA Manager and sponsor, if necessary, within reporting deadlines outlined in the protocol.
  • Any exposure to EPIC (Electronic Health Records system) and/or OnCore (Clinical Trials Management System) is a plus.

PHYSICAL DEMANDS: Standing, sitting, walking, talking, hearing, and visual perception. Lifting up to 25lbs.

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.

#LI-DNI

 

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