As a Senior CRA,  you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

JOB OBJECTIVE

Maximizing site performance and site engagement in UCB conducted clinical studies. Leveraging strong clinical operational and therapeutic expertise (scientific, clinical, disease states, and treatment alternatives knowledge within the therapeutic area(s)) to support execution of the clinical studies.

Responsible for the planning, initiation, coordination and management of all monitoring and monitoring-related activities as well as supervision of all site-related activities to ensure compliance with UCB Standard Operating Procedures (SOPs), Good Clinical Practices (GCP) and regulatory requirements.  Engages with clinical sites to develop, build, and maintain strong relationships with investigators/staff that will ensure high quality investigative sites to support UCB’s clinical development programs. Collaborate with internal and external stakeholders as well as third party vendors. Provide operational support to the CPM/Sr CPM to deliver the study within planned timelines and according to required standards of quality and compliance.

Responsibilities:

Site Engagement Deliverables:

• Develop, communicate, and execute Site Engagement Strategy/Plan working closely with THE Clinical Team and key internal stake holders throughout the life cycle of UCB clinical trials
• Support clinical team in coordinating and executing site engagement activities by understanding the competitive landscape, capturing trial hurdles and using motivational tactics to ensure timely delivery of Sponsor’s trials
• Engage, evaluate and develop a global network of high performing sites through coordinated, consistent interactions using multiple communication channels to create awareness of Sponsor and its activities thereby increasing their desire to partner with UCB
• Develop & maintain relationships with site engagement organizations; assist in identification of high performing sites and key opinion leaders that can contribute to Sponsor forums, boards and/or discussions
• Interact/train new investigators to work on Sponsor clinical trials

Monitoring Deliverables:

• Responsible for all kinds of site visits (e.g. Selection / Initiation / Monitoring / Close-out / Motivational / Support) and sites’ performance regarding set-up, conduct and data collection
• Primary contact for sites regarding study-related issues.
• Responsible for the early engagement with Key Opinion Leaders (KOLs)/ sites / patients organizations and key contact point for these throughout the study.
• Interact/train new investigators to work on UCB clinical trials.
• Attend key therapeutic trainings/meetings and/or industry trainings.
• Support CPM in management of the study, including but not limited to:
• Vendor management
• Training
• Logistics
• Selection of sites
• Maintenance of study tracking
• Oversight of eTMF
• Close cooperation with the Clinical Project Managers and members of the Clinical Trial Teams to inform on all aspects of the clinical trial status at site.
• Ensure appropriate engagement and communication with internal stakeholders regarding site visits and related activities.
• Support the development of key study documents including, but not limited to Case Report Form (CRFs), diaries, informed consent/participant information, the study concept and protocols/amendments including presentations and Investigator Meetings or other trial-related meetings.
• Prepare and/or review monitoring tools, e.g. monitoring manual
• Support CRO/vendor selection activities and provide input in development of contract specifications regarding monitoring activities for clinical trials.
• Review and approval of site regulatory packages
• Prepare or review responses to questions from Regulatory Authorities and IRBs/ECs.

Depending on trial setting:

• Train appropriate internal and CRO personnel on trial-specific monitoring requirements.
• Track monitoring activities including review of regulatory package status, visit reports, queries (nature and frequency), and ensure timely collection of the data.
• Conduct co-monitoring visits with internal or CRO personnel to ensure quality of trial and initiate corrective actions where appropriate.

• A minimum of 5 years of experience in the Pharmaceutical, Biotechnology, and/or CRO industry is required with a preference towards individuals who have experience in site engagement or an investigator facing role (e.g. clinical project manager, study director/coordinator, clinical research associate, patient/site engagement companies)
• S., M.S. degree in a life science/biological related field preferred. At least three years experience in monitoring of trials in clinical development environment, preferably in phase 2-4 if responsibility for phase 2-4.
• Strong Knowledge of GCP and ICH Guidelines.

Why 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.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.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, colour, 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.Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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