WHY VITALIEF?

Vitalief was formed to address the human capital epidemic the research and clinical trial industry is facing today. We are expanding our footprint rapidly as a value-added, innovative Research and Clinical Trial Solution Consulting Company. As a result, we are seeking talented and enthusiastic Clinical Research professionals to join our exceptional team (as full-time, fully benefited employees) to support our clients’ successful planning and execution of research and clinical trials.

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.
• You'll impact clinical research in various therapeutic areas, including oncology, and improve outcomes for diverse populations.
• 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.

Responsibilities:

• Under the direct supervision of the Nurse Manager of Clinical Research Center, performs subject recruitment, consenting, data entry, and other clinical trial activities for Oncology Phase 1 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.
• Manages eligibility check lists, perform patient screening/consenting (informed consent), patient enrollment activation (based on clinical trial agreement and investigator discretion) and managing patient care (patient retention).
• 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 and data management.
• Bachelor’s Degree required.
• Must have some clinical trials experience in Oncology; any exposure to Phase 1 trials is a plus.
• Ability to work on 12 to 15 concurrent trials – must have strong organizational and prioritization skills.
• Keys to success in this role are your ability to demonstrate your versatility, “can do” attitude, and adaptability; leadership/mentorship qualities; strong analytical skills; and the ability to think creatively and working independently to meet deadlines.
• Must possess excellent interpersonal skills to interact with patients in a clear and confident manner.
• 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.
• Clear understanding of Good Clinical Practice (GCP) guidelines.
• Experience ensuring Serious Adverse Events (SAEs) are completed and reported within reporting deadlines outlined in the protocol.
• Demonstrated computer skills with Microsoft Office applications.
• Any exposure to EPIC (Electronic Health Records system) and/or OnCore (Clinical Trials Management System) is a plus.

PHYSICAL DEMANDS: Standing, sitting, walking, talking and hearing. No special vision requirements. 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.

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