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Clinical Trial Specialist

Vitalief
2+ years
$75,000 to $90,000 annually
15 June 12, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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

  • People First Culture: We prioritize personal and professional growth for all Vitalief employees.
  • Innovative Environment: We give everyone a seat at the table and encourage innovation.
  • Employee Commitment: You are encouraged and mentored by the talented Vitalief team to achieve your full potential.
  • Work-Life Balance:
    • 20 Paid Time Off (PTO) days annually
    • 9 paid holidays annually
  • Comprehensive Benefits:
    • Company-paid life insurance
    • Short/long-term disability coverage
    • 401K retirement program
    • Robust healthcare plans to choose from
  • Competitive Salary: $75,000 to $90,000 annually

Work Location

  • Primary Location: On-site in New Brunswick, NJ, five days per week
  • Remote Work: Ability to work one day remote per week after acclimation

Responsibilities

  • Clinical Trial Activities:
    • Patient recruiting, pre-screening, consenting, and retention
    • Activation and regulatory compliance
    • Data management for oncology-related trials
  • Liaison Role: Coordinate between the organization, investigators, research team members, and research sponsors to ensure timely service delivery to patients.
  • Research Record Maintenance: Manage patient consent, eligibility, Case Report Forms (CRF), registration confirmation, and corresponding source documents.
  • Trial Preparation:
    • Protocol feasibility
    • Preliminary study budget
    • Startup meeting preparation
    • Training staff
    • Preparation of IRB applications and regulatory documents
  • Patient Interaction:
    • Inform patients and coordinate procedures per protocol
    • Assess and triage study patients for serious/unexpected adverse events (SAE)
    • Educate patients about diagnosis, treatment options, and available resources

Required Skills

  • Experience:
    • 2+ years in clinical research as a Clinical Research Coordinator
    • Experience in patient recruiting, pre-screening, consenting, retention, activation, regulatory compliance, data management, and SAE reporting
  • Education: Bachelor's Degree required
  • Specialization: Oncology clinical research experience required, experience with solid tumors is a plus
  • Personality: Compassionate, clear, and confident patient interaction
  • Skills: Versatility, strong organizational, time management, and prioritization skills

Physical Demands

  • Standing, sitting for long periods, visual perception, walking, talking, and hearing
  • Lifting up to 25 lbs

Important Note

Vitalief partners with clients such as major medical centers and academic institutions, requiring all on-site resources to:

  • Provide proof of full Covid-19 vaccination
  • Annual influenza inoculation
  • Pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis

Join Vitalief and be part of a team that is making a significant impact in the healthcare industry!