healthcare
Posted 1 weeks agoSr Clinical Research Associate II - Sydney
at Fortrea
Sydney, AustraliaOn-site
Responsibilities
- Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
- Ensure the protection of study patients by verifying that informed consent procedures and protocol
- Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
- Monitor data for missing or implausible data.
- Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy.
- Ensure audit readiness at the site level.
- Prepare accurate and timely trip reports.
- Manage small projects under the direction of a Project Manager/Director as assigned.
- Review progress of projects and initiate appropriate actions to achieve target objectives.
- Organize and make presentations at Investigator Meetings.
- Undertake feasibility work when requested.
- Conduct, report, and follow-up on Quality Control (QC) visits when requested.
- Negotiate study budgets with potential investigators and assist the Fortrea legal department with statements of agreements as assigned.
- Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
- Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management.
- Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned.
- Perform other duties as needed or assigned.
- The statements below are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties.
Requirements
- Qualifications (Minimum Required): University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure), an equivalent amount of