Clinical Research Associate

Apply knowledge of health care and database management to analyze clinical data, and to identify and report trends.

Clinical Research Associate Job Description Template

Our company is looking for a Clinical Research Associate to join our team.


  • Assisting in writing Clinical Study Reports;
  • Preparation of study initiation documents;
  • Assisting in setting up and addressing any issues with clinical study agreements;
  • Regularly reviewing Clinical and Regulatory documentation;
  • Timely writing monitoring reports after each monitoring visit;
  • SIVs;
  • Perform validation of study data against source documentation as required by the sponsor and prepare monitoring reports and letters as necessary;
  • Work with the study start up group to coordinate activities with the site in preparation for the initiation of studies;
  • Plan and participate in Investigator meetings and Clinical Research Associate trainings;
  • In conjunction with study team, support feasibility and site selection process for clinical studies;
  • Train site staff on the EDC system and verify site computer system;
  • Ensure adherence to Good Clinical Practice, investigator integrity and compliance with all study procedures through onsite monitoring visits;
  • Perform investigational product inventory and ensure return of unused materials to designated location/verify destruction as required;
  • Liaising with other countries (International),
  • Work with the study start up group and site staff to obtain regulatory (IRB/IEC) approval of study specific documents.


  • Fluent in written and spoken English;
  • Proven ability to work independently in a fast-paced environment;
  • Bachelor’s degree in health care or life science related field;
  • Must demonstrate excellent computer skills;
  • At least 2 years proven monitoring experience;
  • Strong communication, interpersonal, and organizational skills;
  • Strong working knowledge of Electronic Data Capture, Interactive Voice/Web Response System and Clinical Trial Management System;
  • Sound knowledge of clinical research process and medical terminology;
  • Good understanding of current ICH-GCP (R2) guidelines applicable to the conduct of clinical research;
  • Proven ability to lead and influence at study sites and in a fast paced and collaborative environment;
  • Attention to detail is critical for this role;
  • Good knowledge of concepts of clinical research and drug development;
  • Excellent organisation, analytical and problem-solving skills;
  • Good understanding of electronic data capture, including basic data processing functions;
  • Willingness and ability to travel domestically (and occasionally internationally) as required.