Parexel is seeking Senior Clinical Research Associates for UK‑based sponsor dedicated roles. Experience in oncology trials and RECIST criteria is essential, with a minimum of 5 years in CRO or Pharma trial environments.
Responsibilities
The Senior CRA 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 (SMP) and will be performed virtually for the majority of activities to supplement on‑site visits. The Senior CRA will collaborate with the Site Manager to assure protocol compliance and inspection readiness and will coordinate with institutions and investigators.
* Ensure regulatory, ICH‑GCP and protocol compliance; evaluate site performance, communicate/escalate significant issues and develop action plans.
* Verify that the process of obtaining informed consent has been adequately performed and documented for each subject.
* Protect subject confidentiality and assess factors that might affect subject safety and data integrity, such as protocol deviations, violations and pharmacovigilance issues.
* Conduct monitoring activities using both on‑site and remote methods, where allowed by country regulations.
* Perform source document review and verify that clinical data entered in the Case Report Form (CRF) is accurate and complete.
* Manage reporting of protocol deviations and appropriate follow‑up.
* Apply query resolution techniques remotely and on‑site, and drive resolution to closure within agreed timelines.
* Perform Investigational Product (IP) inventory, reconciliation, and review of storage and security.
* Verify that IP has been dispensed and administered to subjects according to the protocol and identify any risks related to blinded or randomized information.
* Apply GCP and local regulations to ensure IP is appropriately (re)labelled, imported, released and returned.
* Manage reporting of identified issues and follow up to resolution.
* Document activities via follow‑up letters, monitoring reports, communication logs and other required project documents as per SOPs, CMP and SMP.
* Ensure all activities are managed by site personnel who are appropriately delegated and trained.
* Enter data into tracking systems to monitor observations, status and action items; manage site‑level activities and communication to meet project objectives, deliverables and timelines.
* Review data entry timeliness, missing pages, outstanding queries, and database lock timelines.
* Review site signature sheet and delegation of duties log to confirm staff changes are documented and training compliance is maintained.
* Follow up on escalated adverse event monitoring (AEM) report queries.
* Check that site and external facilities, equipment, and supplies are adequate and have valid expiry dates.
* Verify that site 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, IP Accountability Log).
* Collaborate with the primary Site Manager to act as the primary liaison with site personnel.
* Prepare for and attend Investigator Meetings and sponsor face‑to‑face meetings.
* Participate in global clinical monitoring and project staff meetings, including client representation where applicable.
Qualifications
• Minimum 5 years of experience in CRO or Pharma trial environments.
• Demonstrated experience in oncology trials and familiarity with RECIST criteria.
• Ability to evaluate site performance and communicate significant issues to the project team.
• Proficiency in local language required.
• Fluency in English required.
Skills
* Networking and relationship building skills; effective communication with internal and external stakeholders.
* Adaptability to changing technologies and processes, overcoming barriers during implementation.
* Excellent verbal and written communication, presentation and interpersonal skills.
* Ability to build effective relationships with investigator site staff and other stakeholders.
Education
Bachelor’s degree or RN in a related field, or an equivalent combination of education, training and experience.
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