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.