Clinical Research Associate - Ireland

The IQVIA FSP team are changing the life science industry through inspired innovation. Our people make a difference. You could be part of a team that work on exciting complex studies for one single sponsor dedicated program! We are looking for experienced CRA's who care and want to make a difference in the life science industry.

The roles are home-based in any location across Ireland but we are particularly interested in hearing from candidates based in Dublin.

Responsibilities and Duties:

• Working as a CRA you would act as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.

• Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.  

• Gains an in-depth understanding of the study protocol and related procedures.

• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.

• Participates & provides inputs on site selection and validation activities.

• Performs remote and on-site monitoring & oversight activities.

• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. 

• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.

• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.

• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.

Qualifications/Skills

• Minimum of 1 year on-site and independent monitoring experience

• Life science degree / relevant work experience

• Strong knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

• Good therapeutic and protocol knowledge as provided in company training.

• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).

• Full UK driving license with the ability to travel nationwide
  

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At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.