Senior CRA

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.

• All aspects of site management and monitoring activities for assigned applicable Phase I and all Phase II-IV clinical investigator sites within the approved Clinical Development Plan (COP). These global, complex studies are conducted within the standards set by Bayer Global Development, according to Good Clinical Practices (ICH -GCP) and applicable regulatory and legal requirements.
• Managing Investigator site and site activities and monitoring site data, to maintain patient safety and ethical and regulatory compliance necessary to provide quality data required for global regulatory submissions for approval of drugs.
• Managing Investigator sites to assist the Investigator and Site Staff in meeting all aspects of study delivery and commitments to make certain the operational study execution is on track from site selection to site close out.
• Training and supervising cross functional site personnel on study related procedures for the duration of the study.
• Continuously assessing site performance, processes, qualifications of staff, and suitability of facilities for adherence to study protocol, Bayer Healthcare requirements, regulatory and local legal requirements, as well as ICH-GCP.
• Tracking to secure sufficient resources at site to conduct study activities for duration of the study.
• Tracking enrolment activities to remain on track with site commitments. Develops contingency plans to meet site commitments.
• Reviewing patient data at site to maintain safety of patient and patient data is consistent with what is reported in the case report form. Serves as liaison between Investigator and Study Medical Expert to resolve any medical patient-related queries. The data from these clinical sites are required to demonstrate patient safety and efficacy of investigational products which forms the basis of regulatory approval.
• Assuring adequate control of investigational product (study medication), which includes: checking that sites have met all local and legal requirements to receive investigational product, study drug storage, and continually reviewing patient compliance with expected study drug dosing. The Sr. CRA is responsible for study drug accountability at the site level and arranges for destruction of investigational product in accordance with local legal and regulatory requirements.
• Notifying applicable authorities of study closure and final patient status in accordance with ICH and local regulations.
• Periodically reviews Investigator Site File to maintain essential documents according to ICH and SOP requirements
• Rigorous regulatory guidelines exist to maintain overall patient safety related to reporting of serious or unexpected adverse drug reactions. The Sr. CRA is responsible for training the Investigator and site staff on these strict regulations and procedures for timely reporting and as well as managing ongoing compliance. Strict adherence is essential to remain complaint with on lime reporting from Bayer to regulatory authorities and critical for thorough and timely evaluation of patient safely.
• Due to the highly regulated clinical trial environment, the Sr. CRA proactively identifies potential issues and develops site Corrective Actions I Preventive Actions (CAPAs). The Sr. CRA works towards timely and sufficient resolution of issues that may impact compliance or quality of study related activities or data.
• As key contributor to the Trial Master File and study documents at the country level, sees that essential documents are appropriate and filed in a timely manner in the Investigator Site File.
• Incumbent is a key contributor in the preparation, conduct and follow up of Site Audits and Regulatory Inspections to promote a successful outcome. The Sr. CRA is a member of the audit/regulatory inspection team.
• Due to experience and expertise, the Sr. CRA may be a mentor and role model for new or less experienced GRAs on process, study, technical or behavioural competencies. The Sr. CRA may also conduct co-monitoring visits as defined in the Study Oversight Plan to mitigate risks and promote the quality and reliability of study data and processes. In addition, the Sr. CRA may participate in Expert Working Groups for Global SOPs, training or process improvement initiatives
• Conducting Site Selection Visits to confirm the Investigator and Site Staff are qualified, and have suitable resources and facilities to properly conduct the study.
• Completion of site documents necessary for ethics and regulatory approval for site initiation within agreed upon timelines. Meeting all legal, regulatory and Bayer requirements prior to drug shipment to sites as well as all site initiation processes are completed.
• Work with CLM to execute Investigator Agreements and budgets for assigned study sites, and subsequently initiating payments at key milestones

Bachelor's Degree (or equivalent) with 6 - 7 years of relevant healthcare experience including 4 years of monitoring & site management experienceBenefits 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.