Ref #: 31656

Employment type: Permanent - Full-Time

Location: Lima

Posted: 26-Aug-2021

Description

• Do you have clinical trial monitoring experience in Oncology studies? Either as a Coordinator, CTA or monitor?
• Do you love monitoring and being an active part within drug development?

Then look further, this is the role for you!

Our client is looking to recruit an experienced CRA who can demonstrate strong Oncology clinical trial experience


What is Offered
* Full-time
* Permanent career opportunity
* Homebased

The Role and your Responsibilities
• To perform all aspects of CRA duties from site selection, site initiation, through to site routine monitoring visits through to close-out visits and database lock.
• Contributes to Case Report Form (CRF) design and clinical trial document development as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.);
• Involved in recruitment of potential Investigators, preparation of Independent Ethics Committee/ Independent Regulatory Board (IEC/IRB) submissions, notifications to regulatory authorities, translation of study related documentation, organization of meetings and other tasks as instructed by the PM;
• Negotiates investigator budgets and assists with the execution of site contracts with support from the legal department;
• Oversees all aspects of study site management to ensure high quality data resulting in consistently low query levels and in good Quality Assurance reports;
• Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports;
• Communicates effectively with site personnel, including the Principal Investigator (PI), and company management to relay protocol/study deviations and ensure timely implementation of corrective actions;

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