Senior Clinical Research Coordinator

1 week ago

New Brunswick, United States Vitalief Inc. Full time

WHY VITALIEF?

Vitalief is emerging as an innovative Healthcare consulting company, focused on empowering Research and transforming Clinical Trials. As a result, we are seeking a talented and enthusiastic Senior Clinical Research Coordinator to join our exceptional team (as full-time, fully benefited Vitalief employee) to support our mission and our clients’ mission to impact and save lives.


Reasons to work for Vitalief

  • You can actively contribute to our clients’ mission of advancing scientific discoveries that have the potential to change patients' lives for the better.
  • Our PEOPLE FIRST culture prioritizes personal and professional growth for all Vitalief employees.
  • We give everyone a seat at the table – we encourage innovation.
  • 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: Market competitive - based on experience level


Work Location: New Brunswick, NJ


Responsibilities

Under supervision of clinical research leadership staff, the medical staff, and in collaboration with research nurse staff, performs protocol-specific tasks including patient screening, ordering tests, collecting specimens and study documentation of patient reported responses, relative to various Phase 1 Oncology trials.

  • Serves as a liaison (Communicating effectively) 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.
  • Schedules and 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

  • Bachelor’s Degree required.
  • Minimum of 2 or more years of experience in clinical research as a Clinical Research Coordinator, with experience in patient recruiting/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.
  • Oncology clinical research experience is a huge plus.
  • Phase 1 clinical trials experience is a plus.
  • Strong working knowledge of current Code of Federal Regulation and Good Clinical Practice guidelines. 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.
  • Ability to 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.
  • Needs to be communicative and responsive and know when to escalate and communicate issues to management.
  • Capable of independent decision-making, and able to thrive in a fast-paced environment working on multiple clinical trials concurrently.
  • Must have strong Microsoft Office skills.
  • Any exposure to EPIC (Electronic Health Records system) and/or OnCore (Clinical Trials Management System) is a plus.


PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs.


IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.

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