Job Description

OverviewAs a CRA II you will be joining the world\xe2\x80\x99s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. The primary responsibilities of this position 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. Currently Oncology experience is required!ResponsibilitiesWhat you will be doing:\xef\x82\xa7 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.
\xef\x82\xa7 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.
\xef\x82\xa7 Properly trains/re-trains site personnel on the protocol/protocol amendments, systems utilized in the study, and all operational aspects of the trial.
\xef\x82\xa7 Serves as primary contact for site personnel, acting as liaison between site personnel and sponsor study team members.
\xef\x82\xa7 Develops patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines.
\xef\x82\xa7 Ensures subjects\xe2\x80\x99 rights, safety and well-being are protected.
\xef\x82\xa7 Ensures compliance with the procedures to apply in the event of adverse events and serious adverse events.
\xef\x82\xa7 Evaluates the quality and integrity of reported data, ensuring that sites enter data into EDC and resolve queries in a timely fashion.
\xef\x82\xa7 Assists and supports data validation and data cleaning procedures to ensure timelines are met.
\xef\x82\xa7 Identifies, assesses and resolves site performance, quality or compliance problems and develops an appropriate intervention plan for the avoidance of redundant errors and deviations.
\xef\x82\xa7 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.
\xef\x82\xa7 Maintains audit-ready clinical trial documentation. Collects, reviews, monitors, and files required regulatory documentation during study maintenance and at study closeout. Verifies investigator study records are reconciled with the contents of Sponsor files (Trial Master File).
\xef\x82\xa7 Verifies the receipt, handling, accounting, storage conditions and availability of study medications under investigation.
\xef\x82\xa7 Ensures availability of non-clinical materials for sites.
\xef\x82\xa7 Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
\xef\x82\xa7 Gains an in-depth understanding of study protocols and related procedures.QualificationsYou are:\xef\x82\xa7 Position requires BA/BS , preferably in the Life Sciences, or RN
\xef\x82\xa7 Minimum of 2+ years of experience in the pharmaceutical / biotechnology industry monitoring as a Clinical Research Associate from study start-up to database lock.
\xef\x82\xa7 Strong Oncology monitoring experience in phase 1-3 pharmaceutical/ biotechnology clinical trials
\xef\x82\xa7 Possess good 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
\xef\x82\xa7 Good knowledge of concepts of clinical research and drug development
\xef\x82\xa7 Strong working knowledge of EDC, IVRS and CTMS systems
\xef\x82\xa7 Proficiency in the use of the Microsoft Office
\xef\x82\xa7 Ability to handle and prioritize multiple studies and projects. Ability to work effectively in a team/matrix environment. Ability to understand technical, scientific and medical information.
\xef\x82\xa7 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
\xef\x82\xa7 Works with high quality and compliance mindset
\xef\x82\xa7 Possess a valid driver\xe2\x80\x99s license
\xef\x82\xa7 Must be willing to travel and spend 8-10 days /month on site.What ICON can offer you:Our success depends on the quality of our people. That\xe2\x80\x99s why we\xe2\x80\x99ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family\xe2\x80\x99s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family\xe2\x80\x99s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We\'re proud of our diverse workforce and the work we\xe2\x80\x99ve done to become a more inclusive organisation. We\xe2\x80\x99re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 through the form below.https://careers.iconplc.com/reasonable-accommodationsInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless \xe2\x80\x93 there\xe2\x80\x99s every chance you\xe2\x80\x99re exactly what we\xe2\x80\x99re looking for here at ICON whether it is for this or other roles.

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