Clinical Research Associate II Job at Covance – Thailand
Covance
With clinical trial professionals located in more than a dozen countries, Covance can conduct clinical trials anywhere in the world. Covance maintains centers of excellence in study design and clinical development in oncology, CNS, infectious diseases and cardiovascular. Our innovative scientists, clinicians, regulators and health economics experts are committed to the highest quality standards. Our experience in the field offers our CRA’s unsurpassed ability to learn in a wide variety of therapeutic areas!
Senior Clinical Research Associate/Clinical Research Associate II
We seek a Level II Clinical Research Associate (CRA2) to help us ‘bring miracles to market sooner’ by assuming site administration, monitoring, management and registry management responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP. This will involve frequent travel to clinical study sites.
The CRA2 will be responsible 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. Fluent in English, the selected candidate will be counted on to:
• Ensure the study staffs 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 Covance 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 Covance travel policy.
• Prepare accurate and timely trip reports.
• Handle a variety of related activities
Required Experience:
• Minimum of two (2) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits).
• In lieu of the above requirements, candidates with three (3) years of site management and/or study co-ordinator experience will be considered. Those with more than 5 years experience will be considered for Senior CRA position.
• Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH 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.
Required Education/Knowledge:
• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
• In lieu of the above requirement, candidates with three (3) or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered.
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements.
• Thorough knowledge of monitoring procedures.
• Basic understanding of the clinical trial process.
Travel Requirements:
• Available for travel up to 50-80% of the time, including overnight stays as necessary, consistent with project needs and office location.
• Ability to drive and have a valid driver’s license.
At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.
Remuneration will be paid to the right candidate according to their education and Previous experience.
Interested applicants please send your detailed resume to Gynn.Kok@covance.com