Clinical Trial Specialist

2 weeks ago


New Brunswick, 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:  $75,000 to $90,000 annually

Work Location:  Work is 5 days per week on-site in New Brunswick, NJ.  Ability to work one day remote per week after acclimated.

Responsibilities:

  • Under the direct supervision of the Nurse Manager of Clinical Research Center, performs patient recruiting/pre-screening/consenting/retention; activation; regulatory compliance, data management. and other clinical trial activities for solid tumor, high enrollment, adult population Oncology related trials.
  • Serves as a liaison between the organization, investigators, members of the research team (i.e., physicians, nurses, hospital, and laboratory staff), and the research sponsors – to ensure that services are coordinated and delivered to patients in a timely manner.
  • Maintains research record (e.g., patient consent, eligibility, Case Report Forms (CRF), registration confirmation, corresponding source documents, etc.) for all patients enrolled in Oncology trials.
  • Participates in site preparation for trials including protocol feasibility, preliminary study budget, startup meeting preparation, training staff, and preparation of IRB applications and preparation of regulatory documents, study documents and forms.
  • Conducts trial visits by informing patients and coordinating procedures per protocol.
  • Assesses and triages study patients appropriately for serious/unexpected adverse events (SAE), reports and records adverse events according to all applicable regulation and study protocol.
  • Assists patients in understanding their diagnosis, treatment options, and the resources available including educating eligible patients about appropriate clinical research studies and technologies.

Required Skills:

  • 2 or more years of experience in clinical research as a Clinical Research Coordinator, with experience in patient recruiting/pre-screening/consenting/retention; activation; regulatory compliance, data management, and ensuring Serious Adverse Events (SAEs) are completed and reported within reporting deadlines outlined in the protocol.
  • Bachelor’s Degree required.
  • Oncology clinical research experience is required.
  • Any experience working with solid tumors is a big plus.
  • Compassionate personality and ability to interact with patients in a clear and confident manner.
  • Ability to work on several trials concurrently – can demonstrate versatility, “can do” attitude, and possess strong organizational, time management and prioritization skills.

PHYSICAL DEMANDS: Standing, sitting for long periods of time working on a computer, visual perception, walking, talking and hearing. 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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