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Late Phase Clinical Research Associate

Location: Spain, Barcelona or Madrid or home-based dependent upon experience

ICON Commercialisation and Outcomes team combines the industry’s oldest and most experienced Clinical Outcome Assessments (COA) consultancies (Mapi & Oxford Outcomes), and with access to more combined COA experience than all other CROs and consultancies, we can offer fantastic career opportunities. We provide a dynamic, stimulating and rewarding working environment for ambitious and passionate individuals looking to join a global, world-class consultancy business.

Your Responsibilities and Accountabilities:

As a Late Phase Clinical Research Associate, you will be responsible for performing all monitoring and site management activities for observational studies. You will perform routine site visits to ensure that the rights and well-being of human subjects are protected; the trial data is accurate, complete, and verifiable from source documents. You will ensure that all activity is delivered in accordance with the study protocol, GCP/ICH/GEP guidelines and applicable regulatory requirements.

Whilst some travel required dependent upon your study, equally some of your work will be done on a remote basis with the primary focus being on the quality of data collected.

Responsibilities:

Perform site feasibility and site selection in conjunction with the Study team, or independently
Work closely with relevant departments to perform Regulatory and IEC/IRB submissions and contract negotiations
Perform onsite and remote visits including pre-study, site initiation, interim and close out to monitor informed consent procedures, compliance protocol, GCP/ICH guidelines and other applicable regulatory requirements and assure appropriate site performance
Provide timely and accurate visit reports as specified by project specific timelines.
Contribute to sponsor or regulatory site audits/inspections including preparation, attendance and follow-up of audit findings
Maintain regular site contacts to ensure site compliance, enrolment and understanding of study requirements
Maintain the Project Tracking System recording site visit dates, site contact notes, subject and site information
Maintaining high quality standards, including identifying areas for improvement where applicable
Assist with the development of departmental and project specific processes and procedures.

You will have:

A background as a CRA, ideally within late phase studies but not essential
Strong knowledge of ICH/GCP guidelines and/or other relevant guidelines (GEP, GPP) and local requirements (including regulatory)
Some prior experience of study start up preferred
Proficiency with computer/software systems
Proven ability to manage multiple simultaneous tasks
Fluency in written and spoken English and Spanish

Education Requirements:

Bachelor degree or higher preferably in a scientific, medical or life sciences discipline

Next Steps:

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

ICON Plc is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

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Senior CRA

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