Senior Clinical Research Associate (Oncology Experience Preferred) - REGISTER YOUR INTEREST - U[...] in Uxbridge

Register your interest for upcoming Senior Clinical Research Associate opportunities. Parexel is currently registering interest for upcoming sponsor‑dedicated Senior CRA roles based in the UK.

Responsibilities

• The Senior CRA is 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.
• Ensure regulatory, ICH‑GCP and protocol compliance.
• Use judgment and experience to evaluate overall performance of the 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.
• Maintain working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and SOPs/processes.
• Verify that the process of obtaining informed consent has been adequately performed and documented for each subject as required.
• Protect the confidentiality of each subject and assess factors that might affect subject safety and clinical data integrity at an investigator site, such as protocol deviations and violations and pharmacovigilance issues.
• Conduct monitoring activities using different methods, as per the Clinical Monitoring Plan (CMP) or SMP, including on‑site and remote where allowed by country regulations.
• Conduct source data verification and review of site source documents and medical records.
• Verify that required clinical data entered in the Case Report Form (CRF) is accurate and complete.
• Manage reporting of protocol deviations and follow up appropriately.
• Apply query resolution techniques remotely and on site, providing guidance to site staff as necessary and driving query resolution to closure within agreed timelines.
• May perform Investigational Product (IP) inventory, reconciliation and review storage and security.
• Verify that IP has been dispensed and administered to subjects according to the protocol and verify issues or risks related to blinded or randomized information tied to IP.
• Apply knowledge of GCP and local regulations and organizational procedures to ensure IP is appropriately 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 and CMP/SMP.
• Ensure all activities are managed by site personnel who are appropriately delegated and trained.
• Enter data into tracking systems as required to track observations, ongoing status and assigned action items to resolution.
• For assigned activities, understand project scope, budgets and timelines; manage site‑level activities and communication to ensure project objectives, deliverables and timelines are met.
• Adapt quickly to changing priorities to achieve goals and targets.
• Review data entry timeliness, missing pages, outstanding data queries, and timelines for database locks.
• Review site signature sheet and delegation of duties log to confirm any newly added or removed site staff are documented and the log is up to date.
• If site personnel are no longer active on a study, review training compliance with any new and updated training requirements (e.g., protocol amendments).
• Conduct follow up for escalated adverse event monitoring (AEM) report queries.
• Check site and external facilities, equipment, and supplies (clinical and non‑clinical) continue to be adequate to conduct the trial and track expiry dates where applicable.
• Check site‑specific logs to ensure they 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).

Collaboration

• Collaborates with the primary Site Manager who acts as the primary liaison with site personnel.
• Prepares for and attends Investigator Meetings and sponsor face‑to‑face meetings.
• Participates in global clinical monitoring and project staff meetings (inclusive of client representation, as applicable) and attends clinic.

Who are Parexel?

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base. We supported the trials of most of today’s top 50 best‑selling drugs, but equally we enable more niche drug developments that are critical to the well‑being of many patients. You’ll be an influential member of the wider team.

What We Are Looking For In This Role

For every role, we look for professionals who have the determination and courage always to put patient well‑being first. That to us is working with heart. Here are a few requirements specific to this advertised role.

• Networking and relationship building skills.
• Ability to communicate effectively and appropriately with internal and external stakeholders.
• Ability to adapt to changing technologies and processes.
• Effectively overcoming barriers encountered during the implementation of new processes and systems.
• Excellent communication (verbal and written), presentation, and interpersonal skills relating to colleagues and associates, both inside and outside of the organization.
• Identifies and builds effective relationships with investigator site staff and other stakeholders.
• Advanced level or fluency in English is required.

Education

Bachelor’s degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience.

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