Clinical Research Associate - UK -Home Based

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Integrity, Collaboration, Agility and Inclusion. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

This CRA role is a client dedicated one where you will work exclusively on one sponsor's trials and SOPs; you will work for a client that values their staff and puts an emphasis on career development.

The CRA is responsible for the preparation, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with sponsor's procedural documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.

CRA with strong experience may take on additional responsibilities that include additional tasks associated with local study management.

Responsibilities:

• Complies with relevant training requirements.
• Contribute to quality Site Selection through participation in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team, as required.
• Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the life of the trial (investigator meetings, site visits, quality communication, etc.).
• Drive study compliance by executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies. Ensures site staff is trained and the corresponding training records are complete and accurate at any time point during all trial phases.
• Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
• Ensures site is equipped to carry out the trial with adequate site study supplies (such as Non-IP, lab kits, etc.) and clinical drug supplies. This will include oversight of proper handling, storage and return and/or destruction with accurate inventory maintained/documented.
• Ensures quality data (accurate, valid and complete) is provided by the site and queries resolved within expected timelines.
• Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate, with supporting data collected and verifiable with information in the source documents.
• Ensures Inspection readiness for sites by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS and eTMF/IF) according to expectations (metrics) and archiving retention requirements, including storage in a secure area at all times.
• Focuses on Investigator engagement through timely follow up with sites. Completes follow-up letter to communicate relevant information and required corrective action to the investigator and to appropriate stakeholders. Follows the corresponding Monitoring Guidelines for each assigned trial.
• Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team.
• Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements and developing therapeutic knowledge sufficient for role and responsibilities.
• Works closely with LTM to ensure CAPA is completed for QA site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g. On Site Quality Monitoring Visit (OSQMV).
• If applicable, will support negotiation of investigator budgets at site level, support tracking of costs and ensure payments are made at site level, maintaining site relationships.
• May participate in the HA and IEC/IRB submission and notification processes as required/appropriate.
• May contribute as a mentor to a less experienced site manager or to process improvement and training, as appropriate for business needs.
• Ensure timely and accurate CTMS data entries / updates.

To be successful in the role, you will have:

• BA/BS degree/Degree in a health or science related field or equivalent industry experience.
• Minimum a year of clinical trial monitoring experience or equivalent industry experience and completion of a monitoring training course.
• Advanced: 1+ years of clinical trial monitoring experience.
• Specific therapeutic area experience depending on the services need.
• Strong working knowledge of ICH GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
• Strong IT skills in appropriate software and company systems.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.