A great opportunity to move into a CRA II role.
You will be esponsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
- 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 Covance are spent wisely by performing the required monitoring tasks in an efficient manner.
- Ensure audit readiness at the site level
- 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 experience can be substituted as appropriate.
- Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements
- Thorough knowledge of monitoring procedures
- Basic understanding of the clinical trial process
- Valid Driver's License
- Thorough knowledge of Company SOPs regarding site monitoring
- A minimum of 1 (One) year of Clinical Monitoring experience is preferred, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job can be substituted.
- Ability to monitor study sites independently according to protocol monitoring guidelines, SOP, and local regulatory Guidelines
- Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
- Good planning, organization and problem- solving abilities
- Ability to work with minimal supervision
- Good communication and interpersonal skills
- Good analytical and negotiation skills
- Computer competency
- Fluent in local office language and in English, both written and verbal
- Works efficiently and effectively in a matrix environment
- One (1) or more additional years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred, however an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
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