Senior CRA

Senior CRA Job Description Template

Our company is looking for a Senior CRA to join our team.

Responsibilities:

  • Perform on-site monitoring visits from pre-study to close-out;
  • Ensure timely, effective communication with investigational sites, within project teams, with the company and as appropriate, with Client;
  • Prepare project-specific support materials and templates in accordance with protocol and other specifications;
  • Manage assigned investigational sites from pre-study to close-out and archiving, including remote or centralized monitoring activities as required;
  • Manage the content of project site-level Trial Master Files and ensure accuracy and completeness;
  • Provide regular progress updates to the Project Lead;
  • Any other reasonable task as approved by your Line Manager;
  • Conduct technical and protocol training of investigational site personnel, as required;
  • Perform site identification, site feasibility and site selection as required;
  • Assist in the preparation and management of regulatory and ethics applications for clinical research studies as required.

Requirements:

  • Well-developed organizational and time management skills; able to prioritize tasks and work to timelines;
  • Experience in clinical trial authorization approval process in local region;
  • A higher degree is desirable but not essential;
  • Experience with software systems (EDC, CTMS, eTMF, IXRS);
  • Highly motivated, pro-active approach to tasks; able to work effectively within a team or independently;
  • At least 2 years of monitoring experience within the pharmaceutical industry;
  • Good knowledge of drug development process and clinical study phases and competent level of clinical research literacy and use of terminology;
  • Well-developed knowledge and understanding of the principles of Good Clinical Practice and able to demonstrate practical application;
  • Science Graduate, or appropriate level of experience as a health care professional;
  • Strong attention to detail;
  • Well-developed language skills demonstrated ability to communicate effectively in a range of electronic and face to face settings;
  • Accomplished user of Microsoft Office, ability to create and format documents to a good, consistent standard, efficient use of Internet.