Ref #: 34389

Employment type: Permanent - Full-Time

Location: Colombia

Posted: 20-Apr-2021


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 clients 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

* Permanent and full-time contract of employment seconded to our client
* Home-based working
* Salary according to actual level of skills and experience
* Company benefits to include generous annual leave plus bank holidays etc
* Fully structured 4-week training for all new starters

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)
•* Full working eligibility
•* Ability to work effectively within fast-paced working environments