Job code : CRA2

Responsibilities:

• May serve as lead monitor for a protocol or project and assist in establishing monitoring plans.
• Review progress of projects and initiate appropriate actions to achieve target objectives.
• Organize/make presentations at Investigator Meetings.
• Report, write narratives and follow-up on serious adverse experiences.
• Interact with internal work groups to evaluate needs, resources and timelines.
• 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.

On-Site Monitoring Responsibilities:

• Ensure that study staff has received the proper materials and instructions.
• 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.
• Prepare accurate and timely trip reports.

Qualifications:

• Minimum of two years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits).
• Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, 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.
• University/college degree (life science preferred), or certification in a related allied health profession from an accredited institution (e.g., nursing certification, medical or laboratory technology).
• Good planning, organization and problem solving abilities.
• Ability to work with minimal supervision.
• Good communication, interpersonal, analytical and negotiation skills.
• Computer competency.
• Fluent in local language as well as English, both written and verbal.