Ref #: 25222

Employment type: Permanent - Full-Time

Location: Romania

Posted: 13-Nov-2020

Description

Due to continued growth, we are looking for a Clinical Research Associate (Level II or Senior) to work in early phase studies for a global and prestigious pharmaceutical company.

As a (Sr) Clinical Research Associate in the early phase study team, you will perform and coordinate all aspects of the clinical monitoring and site management process.
Previous experience in on-site monitoring is required.


Requirements

Minimum of a Bachelor of Science degree in a health related field
2-3 years of independent on-site monitoring experience with multi therapeutic area experience
Experience in monitoring early phase studies would be an advantage
Ability to travel to Moldova, Georgia and Ukraine.

Summary of the job

CRA serves as primary contact point between the sponsor and the investigational site. A CRA is assigned to clinical trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through data-base lock.

Responsibilities include site selection, pre trial assessment, subject recruitment and retention planning, site initiation, monitoring and close-out. Partnera with the CTA/IDA, LTM and GTM to ensure overall site management while performing trial related activities for assigned protocols. May contribute to process improvement, training and mentoring of other CRAs.



PRINCIPAL RESPONSIBILITIES

The primary point of contact between site staff and sponsor
Leadership of site management for the selection and initiation of sites as well as conduct and closing activities of the appointed studies in compliance with local regulations, ICH-GCP, Client procedures and protocol requirements to ensure data quality and study subject protection
Managing the site to meet patient recruitment rate and target
Delivery of results that have direct impact on the successful completion of the clinical programme
Communication about progress and critical issues that may impair trial progress to Local trial Manager (LTM) and/or Regional Trial Manager (RTM)

Keywords:

CRA, Early Phase, Clinical Research Associate, Phase I, Phase II, Clinical Trial Monitor, Sub-Investigator, Investigator, Assistant Professor, Remote CRA, Inhouse-CRA, CTA, Clinical Trial Assistant, Clinical Research, Clinical Trials, Clinical Studies, Hospitals, Medical University, Pharmaceutical, CRO, Pharma, Contract Research Organisation, Biotech, Health, Monitoring, Kiev, Ukraine


DOCS has partnered with a highly prestigious organisation with one of the most robust pipeline within the industry. We have a great job opportunity for a physician/medical doctors who are ready to further develop their career and enjoy working for a global organisation .