Biotech/Pharmaceutical

Clinical Data Coordinator

Contract

Penfield Search Partners

Contact: Neisha Camacho/Terra Parsons – Teamnt@penfieldsearch.com

Job Description: Under limited supervision, responsible for the operation of a specialized oncology clinical research projects with one or more faculty members or managers within a recognized unit. Assists with research project tasks to include recruitment, data collection, and the day to day operations of research projects. May act as liaison with other departments, divisions and organizations.

Job Duties:

  • Plans, organizes and conducts large and complex oncology clinical research projects according to protocol; reviews progress and evaluates results.
  • Oversees conduct of assigned oncology clinical trials to include: patient screening, eligibility, enrollment, coordination of required trial procedures, assist with informed consent process, assist with questions from patient/family members regarding  clinical trial participation, assures maintenance of study records via research files, Velos, and EMR systems.
  • Demonstrates broad knowledge of assigned protocols including the specific investigational/conventional agents, knowledge of eligibility criteria (including inclusion, exclusion and required procedures), routes of administration, mechanism of action, side effects, treatment schedules, follow-up timeframe, data entry, study closure and records retention requirements
  • Demonstrates knowledge of all websites requiring access for study purposes.
  • Monitors and records subject compliance with study medication and protocol treatment.
  • Suggests options for improving quality, identifies potential problems, and recommends and implements solutions.
  • Educate staff (infusion room, clinic nurses when applicable, PK, teammates, Pharmacy, VA coordinators, etc) on trial conduct, assuring documents are current and available in the RESEARCH folder. And wherever information needs updating (i.e. BEACON if treatment schedule is amended or labs removed/added). 
  • Gathers data; supervises data collection and verification; and has oversight for literature reviews.
  • Study maintenance: screening logs, adverse event logs, SAE reports, progress reports, data and query management as well as expectation and query reports.  Monitor trial for amendments to the protocol. 
  • Participate in required site initiation visits and in-service trainings.

Qualifications: 

  • Bachelor’s degree in an educational/social science or related field is required, Masters preferred.
  • 4 years of related experience is required.

Tagged as: Clinical Data Coordinator