Site Monitor (CRA) - 1 year monitoring experience required

Role: Site Monitor (CRA)

Location - UK based - nationwide travel 

Sponsor dedicated 

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

The Site Monitor will be responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements at the site level.  Monitoring will be conducted in line with the Study Monitoring Plan and will be performed virtually for the majority of activities to supplement on-site visit requirements.  The Site Monitor will collaborate with the Site Manager to assure that the site is in compliance with the protocol and is inspection ready. The Level 1 Site Monitors should have at least 1 year of demonstrated experience of monitoring (virtual or onsite) and will need to speak the local language of the countries they will monitor in.

What you will be doing:

• Ensuring regulatory, ICH-GCP and protocol compliance.  Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates significant issues to the project team and develops action plans.  Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Per the Clinical Monitoring/Study Monitoring Plan (CMP/SMP):  Ability to conduct monitoring activities using different methods, e.g., both on-site and remote, where allowed by country regulations.
• Conducts Source Document Review and Source Data Verification of appropriate site source documents and medical records
  - Verifies required clinical data entered in the case report form (CRF) is accurate and complete.
• Manages reporting of protocol deviations and appropriate follow-up.
• Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines 
  - Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. 
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. 
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.

You are:

Training and Education

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• Proficiency in local language preferred. English is required

Prior Experience

• A minimum of 12 months experience as a clinical monitor with demonstrated experience of monitoring (virtual or onsite)

Technical Competencies

• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Must demonstrate good computer skills and be able to embrace new technologies
• Excellent communication, presentation and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis
• Demonstrated networking and relationship building skills
• Ability to communicate effectively and appropriately with internal & external stakeholders
• Ability to adapt to changing technologies and processes
• Demonstrated experience of utilising systems like Siebel CTMS, eTMF , eISF (Florence) OR can demonstrate skill sets that show they have agility to work with new systems to support monitoring practice

Behavioral Competencies

• Effectively overcoming barriers encountered during the implementation of new processes and systems
• Identifies and builds effective relationships with investigator site staff and other stakeholders
• Effective verbal and written communication 

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve 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’s 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’s 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/benefits

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 or submit a request here.

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.