Senior Clinical Research Associate (Oncology Experience Required) - UK - FSP

## About the Role Parexel are seeking Senior Clinical Research Associates for UK based sponsor dedicated roles. Experience in oncology trials and RECIST criteria is essential. A minimum of 5 years' experience in CRO or Pharma trials environments is also essential. 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 visit requirements. The Senior CRA will collaborate with the Site Manager to assure that the site complies with the protocol and is inspection ready and will coordinate with institutions and investigators at the local level. ## Responsibilities - 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 Standard Operating Procedures (SOPs)/processes. - Verifies the process of obtaining informed consent has been adequately performed and documented for each subject as required. - Demonstrates diligence in protecting the confidentiality of each subject and assesses factors that might affect subject safety and clinical data integrity at an investigator site such as protocol deviation and violations and pharmacovigilance issues. - Per the Clinical Monitoring Plan (CMP) or 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 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. - May perform Investigational Product (IP) inventory, reconciliation and reviews storage and security. - Verifies the IP has been dispensed and administered to subjects according to the protocol and verifies issues or risks associated with blinded or randomized information related to IP. - Applies knowledge of GCP and local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported, and released and returned. - 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. ## Requirements - Experience in oncology trials and RECIST criteria is essential. - A minimum of 5 years' experience in CRO or Pharma trials environments is also essential. - Compliance with ICH GCP and local requirements at the site level. - Ability to conduct monitoring activities using different methods, (e.g., both on site and remote) where allowed by country regulations. - Knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company Standard Operating Procedures (SOPs)/processes. - Experience in managing reporting of protocol deviations and appropriate follow up. - Experience in query resolution techniques remotely and on site, and providing guidance to site staff as necessary. - Experience in managing reporting of identified issues and managing follow up to resolution. - Experience in documenting activities via follow up letters, monitoring reports, communication logs, and other required project documents. ## Nice to Have - None specified. ## Benefits - Not specified.