Description:
On behalf of our client, we are currently looking to recruit a Senior CRA. This position can be office based or home-based.
Key responsibilities of this role include;
·Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
·Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
·Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
·Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager.
· Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
Qualifications
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
• Bachelor's degree in a health care or other scientific discipline or educational equivalent and 2 years of on-site monitoring experience
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical
Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
• In depth therapeutic and protocol knowledge as provided in company training
For further information please call Linda at +353 1 2784671 or email your CV in the strictest confidence to ldunne@thornshaw.com . Log on to www.thornshaw.com for more jobs.
Keywords: CRA, Clinical Research Associate, Senior CRA, Senior Clinical Research Associate, Clinical Research, Clinical Trials, Ireland Jobs