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;
- 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.