Clinical Research Coordinator

2 months ago

Teaneck, United States PRISM Vision Group Full time
Summary:

The Clinical Research Coordinator reports to the Manager of Clinical Research and will aid in the coordination and conduct of research under the supervision of a designated physician. The Clinical Research Coordinator will perform a variety of duties involved in the collection, compilation, documentation and analysis of clinical research data. The Clinical Research Coordinator has knowledge of the research studies, rationale, subjects and procedures associated with the studies.

Role and Responsibilities:

  • Leads recruitment efforts and screens potential patients for eligibility for studies.
  • Obtains informed consent from patients and conducts study visits for clinical trials
  • Creates Case Report Forms
  • Completes assessments on study subjects as per protocol
  • Documents study assessments
  • Enters study data into EDC systems
  • Collects, processes, stores and ships lab specimens; documents lab procedures, lab results and follows up with patients and medical staff as necessary
  • Coordinates, monitors visits with CRAs for each trial to ensure accurate documentation; makes corrections to data as necessary
  • Assists during Sponsor and FDA audits
  • Responsible for submissions and reports to the IRB; maintains documentation of IRB communications and decisions
  • Documents adverse events and notifies PI, sponsor and IRB
  • Assumes test article accountability
  • Possesses a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility
  • Maintains compliance with Good Clinical Practice; Clinical Safety Data Management, 21 CFR, and has IATA certification
  • Travels to investigator meetings
  • Participates in weekly meetings with the research team, provides study metrics
  • Responds to requests in a timely manner, gives/receives correct information, encourages dialogue and follow-through, secures accurate signatures, maintains files in an organized and up-to-date manner
Qualifications:

Education: Bachelor’s degree preferably in Science or related field. Equivalent relevant experience and/or training in lieu of education is acceptable.

Experience: 2+ years’ relevant experience (e.g. research, clinical, interaction with study population, program coordination)

Knowledge/Skills/Experience:
  • Excellent Excel, Word, PowerPoint and reporting skills
  • Excellent interpersonal skills to deal effectively with patients, physicians, clinicians and administrators
  • Excellent organizational skills and self-management skills to independently manage work flow
  • Ability to prioritize
  • Meticulous attention to detail
  • Knowledge of medical terminology
  • Knowledge of good clinical practice, FDA, OHRP, HIPAA policies
  • Experience using Microsoft Office Suite
  • Certification through either ACRP or SoCRA highly preferred

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