As a Senior CRA, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Accountable for site start-up and activation
- Maintain a thorough knowledge of assigned protocols
- Supports activities related to site initiation, including training, collection of necessary documentation, and access to systems
- Ensure site monitoring readiness in anticipation of first subject first visit
- Be accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets; Responsible for enrollment support and ensure progress by responding to recruitment issues from investigators.
- Maintain regular communications with investigator sites to gather status updates and drive delivery to study goals eg. recruitment, data entry timelines etc).
Accountable for study conduct and close-out
- 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.
- 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.
- Performs 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.
- Manages reporting of identified issues and manages follow-up to resolution.
- Documents activities via follow-up letters, monitoring reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Study Monitoring Plan.
- Ensures all activities are managed by site personnel who are appropriately delegated and trained.
- Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
- For assigned activities, understands project scope, budgets, and timelines; manages site-level activities /communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.
- Review Data entry timeliness in line with outlined requirements, missing pages, outstanding data queries, timelines for database locks.
- Review site signature sheet and delegation of duties log to confirm any newly added or removed site staff are documented appropriately and the log is up to date. Where the site or Site Signature Sheet and Delegation of Duties Log indicates site personnel are no longer active on a study review and assess training compliance with any new/updated training requirements (i.e., protocol amendment(s), etc.)
- Conduct Follow-up for Escalated AEM Report Query
- Check the site/external facilities, equipment, and supplies (clinical and non-clinical) continue to be adequate to conduct the trial and with their expiry dates (as applicable)
- Review research specimen sample documentation, storage and processing and ensure shipments are sent to central lab as required.
- Check site-specific logs are complete and up to date (e.g., Site Visit Log, Screening and Enrollment Log, Signature Sheet and Delegation of Duties Log, Subject Identification Code List, Investigational Product Accountability Log).
- Act as the primary liaison with site personnel.
- May attend Investigator Meetings and/or other face to face meetings.
- 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
- 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.
- Performs 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.
- Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback.
- Oversight and management of site deliverables to study targets, i.e. data cuts/sweeps, interim analyses, database locks, helping to oversee data is up to date and any other site-facing deliverables, i.e. investigator signatures.
- Follow the Clinical Monitoring/Study Monitoring Plan (CMP/SMP) and proactively put in place mitigations for known/anticipated risks.
- Support development and delivery including issue resolution of decentralized capabilities at investigator sites e.g. home health, ePRO, DTP etc.
- Assure quality and consistency in the delivery of monitoring
- Implement monitoring efficiencies and best practices for study/region/program
- Support shaping the local clinical development environment with a goal to enhance Pfizer reputation in scientific leadership
- Bachelor’s degree
- A minimum of five years of CRA experience (including min. 3 years of experience in oncology)
- 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 utilizing systems like CTMS
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
At 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’ve done to become a more inclusive organisation. We’re 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-accommodations
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.
