About Company
ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology, and medical device industries. With a mission to accelerate the development of drugs and devices that save lives and improve quality of life, we operate across 53 countries and have a dedicated team of over 40,000 employees. We are at the forefront of innovation in clinical research, leveraging advanced technologies and deep therapeutic expertise to deliver robust, high-quality data. Our collaborative and supportive culture fosters professional growth and recognizes the critical impact each team member has on bringing life-changing treatments to patients worldwide. Joining ICON means becoming part of an organization committed to excellence, integrity, and making a real difference in global health.
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Job Description
We are seeking an experienced and dedicated Clinical Research Associate (CRA) II to join our dynamic team in Camden, London. This pivotal role involves the comprehensive monitoring and management of clinical trials across various therapeutic areas, ensuring adherence to study protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and relevant regulatory requirements. As a CRA II, you will be responsible for conducting on-site, remote, and hybrid monitoring visits to investigator sites, building strong relationships with site staff, and providing essential guidance to facilitate successful trial execution. Your work will directly contribute to the integrity and quality of clinical trial data, ultimately impacting the development of new treatments. We are looking for a proactive individual with a keen eye for detail, excellent communication skills, and a passion for advancing medical science. This role offers the opportunity to work on cutting-edge research, collaborate with leading medical professionals, and develop your career within a globally recognized Contract Research Organization (CRO). If you are driven by the prospect of improving patient outcomes and thrive in a challenging yet rewarding environment, we encourage you to apply.
Key Responsibilities
- Conduct comprehensive monitoring visits (on-site, remote, and hybrid) to ensure compliance with study protocol, GCP, SOPs, and regulatory requirements.
- Verify the accuracy and completeness of case report forms (CRFs) and source documentation against patient medical records.
- Manage and resolve data queries, ensuring data integrity and quality.
- Provide training and support to investigator site staff on study protocols, procedures, and relevant regulations.
- Ensure timely and accurate reporting of adverse events and serious adverse events (AEs/SAEs).
- Participate in investigator meetings and site selection processes.
- Maintain detailed documentation of site visits and communications.
- Assist with site start-up activities, including document collection and ethical committee submissions.
- Identify and address potential issues at investigator sites, escalating as necessary.
- Foster strong working relationships with investigator site personnel.
Required Skills
- Bachelor's degree in a life science, nursing, or related health field.
- Minimum of 2 years of independent clinical monitoring experience as a CRA.
- Demonstrated knowledge of ICH-GCP guidelines and relevant regulatory requirements.
- Excellent written and verbal communication skills.
- Strong organizational skills and attention to detail.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Ability to work independently and as part of a team.
- Valid UK driving license and ability to travel extensively within the UK.
Preferred Qualifications
- Experience in oncology, cardiovascular, or rare disease therapeutic areas.
- Previous experience with remote/centralized monitoring tools and techniques.
- Master's degree or higher in a relevant scientific discipline.
- Certification as a Clinical Research Associate (e.g., ACRP or SoCRA).
Perks & Benefits
- Competitive salary and performance-based bonuses.
- Comprehensive health and dental insurance.
- Generous paid time off and holiday allowance.
- Company pension scheme.
- Opportunities for continuous professional development and training.
- Career progression pathways within a global organization.
- Employee assistance program.
- Flexible working arrangements (hybrid model).
How to Apply
Interested candidates are encouraged to apply by clicking the official application link below. Please ensure your CV and cover letter clearly outline your relevant experience and qualifications for this role. Only applications submitted through our official careers portal will be considered.
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