Senior Clinical Research Associate

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

What will you be doing?

The primary responsibilities of the Senior Clinical Research Associate include assessing qualifications of potential clinical study sites, implementing clinical studies at participating sites, managing the conduct of clinical studies at sites, ensuring the quality of site performance, and closing clinical studies.

This individual will ensure that clinical trials are conducted according to the approved protocol/protocol amendments and comply with Good Clinical Practice (GCP), Company SOPs and all applicable regulatory requirements.

The Senior CRA is a seasoned professional with wide-ranging experience and a thorough understanding of GCP and ICH principles. The experienced Senior CRA identifies and resolves complex issues where an analysis of situations and data requires an in-depth evaluation of multiple factors. Exercising sound judgement in selecting methods and techniques and evaluating criteria for resolving issues, the Senior CRA will establish strong, positive relationships with both internal and external partners. This individual contributes to the determination, development and/or implementation of efficient and effective approaches to study site management.

• Responsible for evaluating, initiating, monitoring and closing out clinical study sites. Documents all activities in clear, comprehensive and accurate Monitoring Visit Reports, Contact Reports and follow up letters within required timelines.
• Ensures that the conduct of clinical studies at sites is in accordance with the protocol/protocol amendments, Good Clinical Practice regulations, International Harmonization Guidelines, applicable company Standard Operating Procedures (SOPs), and all applicable regulatory requirements.
• Properly trains/re-trains site personnel on the protocol/protocol amendments, systems utilized in the study, and all operational aspects of the the study.
• Serves as primary contact for site personnel, acting as liaison between site personnel and sponsor study team members.
• Develops patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines.
• Ensures subjects’ rights, safety and well-being are protected.
• Ensures compliance with the procedures to apply in the event of adverse events and serious adverse events.
• Evaluates the quality and integrity of reported data, ensuring that sites enter data into EDC and resolve queries in a timely fashion.
• Assists Data Management in development, review and/or testing of eCRFs and eCRF Completion Guidelines. Also supports data validation and data cleaning procedures to ensure timelines are met.
• Identifies, assesses and resolves site performance, quality or compliance problems and develops an appropriate intervention plan for the avoidance of redundant errors and deviations.
• Communicates with Investigators, site staff, Sponsor Study Team Members, and/or QA on issues related to protocol conduct, subject recruitment and retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Maintains audit-ready clinical trial documentation. Collects, reviews, monitors, and files required regulatory documentation during study maintenance and at study closeou Verifies investigator study records are reconciled with the contents of Sponsor files (Trial Master File).
• Verifies the receipt, handling, accounting, storage conditions and availability of study medications under investigation.
• Ensures availability of non-clinical materials for sites.
• Demonstrates strong site relationships and ensures continuity of site relationships through all phases of the the study.
• Demonstrates an in-depth understanding of study protocols and related procedures.
• Contributes to CRA team knowledge by acting as process and/or system Subject Matter Expert (SME), sharing best practices; developing new process(es), when needed; making recommendations for continuous improvements.
• Providing training/coaching/mentoring to other CRAs as needed.
• Assists in developing presentations for internal team and Investigator meetings.
• Assumes responsibility of and independently completes special projects, if assigned, with minimal monitoring management guidance.

What do you need to have?

• Position requires BA/BS preferably in the Life Sciences, or RN,
• Minimum of 5+ years of experience in the pharmaceutical / biotechnology industry monitoring as a Clinical Research Associate from study start-up to database lock
• Strong Oncology monitoring experience in phase 1-3 pharmaceutical/ biotechnology clinical trials
• Demonstrated high level of monitoring skill with independent professional judgment
• Possess excellent understanding and working knowledge of ICH guidelines, Good Clinical Practices (GCP), PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, and other relevant, local regulatory requirements
• Strong knowledge of concepts of clinical research and drug development
• Strong working knowledge of EDC, IVRS and CTMS systems
• Proficient in the use of Microsoft Office
• Ability to work highly independently across multiple studies, projects and sites. Ability to work effectively in a team/matrix environmen Ability to understand technical, scientific and medical information.
• Demonstrated strengths in planning, organizational, project management, analytical, oral and written communication, effective time management, conflict management, problem solving, attention to detail, and interpersonal skills
• Demonstrated ability to mentor/lead
• Works with high quality and compliance mindset
• Possess a valid driver’s license
• Must be willing to travel and spend 8-10 days /month on site.
• Ex-US: Proficient in speaking and writing English and the country language when applicable

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.