FORTREA SINGAPORE PTE. LTD.
Sr. Clinical Research Associate I
- Compensation
- SGD 6.5K–SGD 9K / mo
- Location
- Singapore
- Work setup
- Not specified
- Seniority
- Senior
- Employment
- Not specified
- Experience
- 3+ years
- Category
- Healthcare
- Posted
Skills
Must have
- University or college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory
- In lieu of the above education requirement, candidates with a minimum of 3 years relevant clinical research experience in pharmaceutical or CRO industries will be considered.
- Thorough knowledge of regulatory requirements including a basic understanding of regulatory requirements in other countries.
- Thorough understanding of the drug development process.
- Fluent in local office language and in English, both written and verbal.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Full description
Job Level & compensation offered may vary depending on candidates’ experiences and competencies.
Job Overview:
The Senior CRA I is responsible for site monitoring and site management. Responsibility for clinical studies according to Fortrea, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. The Senior CRA I assure the implementation of project plans, as assigned. Function as leader for projects of limited scope, as assigned. Assume line management responsibilities, as assigned. Act in the project role of a Local Project Coordinator or Lead CRA as assigned.
Summary of Responsibilities:
- 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.
- Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned.
- Responsible for all aspects of site management as prescribed in the project plans.
- General On-Site Monitoring 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 requirements are adhered to according to the applicable regulatory requirements.
- 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.
- Travel, including air travel, may be required and is an essential function of the job.
- Prepare accurate and timely trip reports.
- Manage small projects under the direction of a Project Manager/Director as assigned.
- Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans and trip report review as assigned.
- Review progress of projects and initiate appropriate actions to achieve target objectives.
- Organize and make presentations at Investigator Meetings.