Oncology Clinical Trial Monitor

3 weeks ago

London, Greater London, United Kingdom Cancer Research UK Full time

Join Cancer Research UK in the fight against cancer

We are seeking an Oncology Clinical Trial Monitor to oversee clinical trials conducted by Cancer Research UK's Centre for Drug Development across various investigational sites in the United Kingdom.

The Cancer Research UK Centre for Drug Development (CDD) stands as a unique charity-funded facility dedicated to drug development. Our innovative research is solely focused on translating scientific advancements into tangible benefits for patients at an accelerated pace. CDD sponsors early-phase and precision medicine clinical trials involving oncology agents. Our extensive portfolio is comparable to that of a medium-sized pharmaceutical entity, encompassing antibodies, cell therapies, vaccines, drug conjugates, and small molecules, creating a stimulating and dynamic work environment.

As an Oncology Clinical Trial Monitor, you will serve as the critical link for CDD, ensuring the integrity of early Phase I and II clinical trials at investigational sites throughout the United Kingdom. Your role will involve ensuring adherence to standard operating procedures (SOPs), policies, ICH-GCP (International Conference on Harmonisation-Good Clinical Practice), European Union Directives, UK legislation, and other regulatory standards. You will initially focus on a significant nationwide trial currently in the setup phase, and once recruitment begins, you will manage a designated area, ideally close to your home.

Working within a multidisciplinary team, you will cultivate strong relationships with investigators, scientists, and site personnel to guarantee that Cancer Research UK clinical trials are conducted ethically, efficiently, within budget, and on schedule. This position offers a remarkable opportunity for a Clinical Research Associate, Clinical Study Coordinator, or clinical trial assistant to make a meaningful impact on the execution of our trials, surrounded by individuals equally committed to combating cancer.

Key Responsibilities:

  • Conduct site selection visits, coordinate necessary documentation, and initiate sites.
  • Assist in the preparation, ongoing review, and archiving of Trial Master Files (TMFs), Investigator Trial Files (ITFs), and Pharmacy Files (PFs).
  • Review draft protocols and protocol amendments, case report forms (CRFs), and informed consent documents (ICDs) as needed.
  • Evaluate the research ethics committee (REC) application using the latest system and aid in the preparation of all supporting documentation.
  • Prepare essential trial documentation prior to initiation, including but not limited to: laboratory manuals, worksheets, diary cards, and patient identification cards.

Qualifications:

  • A degree in Biological Sciences or an equivalent nursing qualification/experience.
  • Familiarity with ICH/GCP, EU legislation, and clinical trial methodologies.
  • Experience in monitoring early-phase trials, particularly in the oncology therapeutic area, is advantageous.
  • Proficiency in Microsoft Office (TM) – Word, PowerPoint, and Excel.
  • A flexible and proactive approach with a positive attitude.
  • Proven problem-solving abilities.
  • Strong time management and organizational skills to facilitate independent monitoring of multicenter trials.

Our organizational values guide our actions:

Bold: Act with ambition, courage, and determination.

Credible: Act with rigor and professionalism.

Human: Act to positively impact individuals.

Together: Act inclusively and collaboratively.

We seek individuals who can embody these values and leverage them to advance our mission to combat cancer.

What We Offer:

We foster a work environment that prioritizes your well-being and offers a comprehensive benefits package, a variety of career and personal development opportunities, and high-quality resources. Our policies and processes are designed to enhance your work-life balance, support your career progression, and help you achieve your personal well-being objectives.

Explore our benefits by visiting our careers webpage.

Application Process:

We implement an anonymized shortlisting process to uphold our commitment to equality, diversity, and inclusion. While CVs are required for all applications, they will only be reviewed once you are invited for an interview. We encourage you to complete the work history section of the online application form to facilitate a fair and objective assessment.

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