Ref #: 31978

Employment type: Permanent - Full-Time

Location: Mexico City

Posted: 15-Sep-2021

Description

Clinical Research Associate II

The Role and your Responsibilities

The experienced field based / home based CRA (Clinical Research Associate) will perform all aspects of CRA work covering site evaluation, site initiation visits, site monitoring and close-out visits across phase II and phase III clinical trials in different medical indications.

CRA responsibilities:
* Facilitate subject enrolment at the site level with focused patient recruitment strategies and action plans;
•* Identify site needs and site-related issues, escalate and/or initiate corrective actions when necessary, providing solutions for site staff to facilitate the clinical trial process;
* Respond to site-related queries and escalate site-related issues with operational site management responsibility;
•* Perform investigational product accountability and reconciliation, maintain site study supplies, and facilitate the resolution of clinical queries to investigative staff;
•* Build and maintain solid and long-term professional relationships with investigators and site staff;
•* Ensure clinical study sites are conducting clinical trials in compliance with the respective protocol, our client's SOPs and applicable ICH/GCP guidelines and regulations;
* Assist in preparing sites for audits, review audit reports and contribute to resolving findings;
•* Implement new technologies and systems at clinical sites, e.g. EDC systems;
* Ensure appropriate safety reporting as well as tracking and reporting of adverse events (AEs and SAEs) and to verify case reports and source documentation;
•* Input and maintain electronic site management systems, provide input into clinical monitoring plans, input into case report forms and study-related documents as requested.

What is Offered

As a field-based/home-based CRA, you will have the opportunity to work with a sought-after client’s clinical trials in phase I-IV across different therapeutic areas. Our client is looking to recruit motivated and dedicated CRAs at all levels (Clinical Research Associate) in various regions

What is Required
* Previous CRA experience of commercial phase II and phase III studies
* Proven external/independent clinical trial monitoring experience gained in the country
* Life science degree (BSc) o RN (registered nursing qualification)
•* English skills
•* Full working eligibility
•* Ability to work effectively within fast-paced working environments

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

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