Senior Clinical Research Associate (UK)

Who We Are

Celebrating 40+ years!

Theradex Oncology is a full-service CRO specializing in oncology. The company manages global oncology trials and programs. The company was founded in 1982 working with the National Cancer Institute, which led to its expansion to working with industry sponsors developing cancer therapeutics. As a service based company we support both domestic and international sponsors in the conduct of both early and late phase trials. As part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, as part of the team you will the work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference.

What You'll Do

Hiring a Full time Permanent SCRA based in UK (Remote)

The primary responsibilities of this position include, but are not limited to, the following:

• Act as the routine liaison between study site and the project team for study related issues.
• Ensures protection of subjects, subjects' rights and the integrity of data through monitoring of adherence to Good Clinical Practice, applicable regulatory requirements, Standard Operating Procedures and protocol compliance
• Conducts pre-qualification, initiation, routine monitoring, remote monitoring, and close-out visits in accordance with the relevant SOPs and the specific project scope of work to include but not limited to:
  • Source document review and comparison to CRF data
  • CRF review/retrieval and data corrections
  • IMP accountability
  • Maintenance of on-site investigator files
  • IEC/IRB documentation
  • Local laboratory documentation
  • Maintenance of investigational supplies
  • Reviews consent process for each subject (Informed Consent Form and source documentation)
  • Verify patient eligibility
  • Assess protocol compliance and deviations
  • Handling of safety and efficacy issues, including, but not limited to:
    • Serious adverse event reports
    • Adverse event trends
    • Treatment failures/outcomes
  • Conducts and documents onsite visits/contacts, including:
    • Pre-study visits
    • Initiation visits
    • Routine visits
    • Study completion visits / Close-out visits
    • Assessment and Training Visits
  • Telephone contact
  • Site visit report preparation within study specific timeframe
• Responsible for all aspects of site management as described in the study plans
• Proactively identify and resolve issues and potential site and study issues.
• Assist with regulatory and study start-up activities including contract and budget negotiations, as required.
• Ensure clinical data integrity and adherence to study timelines.
• Provide ongoing accurate and timely updates and support to project management.
• Function as a lead monitor for assigned projects, as required
• Mentor junior members of the team.
• Prepare and deliver staff training sessions.
• Clinical review of individual patient listings
• Initial clinical review of comprehensive patient data listings
• Initial review of study start-up materials: SOPs, draft CRFs, completion manual, compliance forms, study prompters/calendars
• Assist in the day to day running of projects assigned.
• Prepare and/or assist in the preparation of project specific materials e.g., status reports, newsletters, templates, etc.
• Participate in project administration as required e.g., photocopying, binder preparation, start-up pack preparation etc.
• Maintain current knowledge related to cancer therapy, clinical trial design and conduct, and good clinical practice through literature reviews and other educational opportunities
• Perform other duties as assigned by management

What You Need

Level of Education

• At minimum, Bachelor's degree (BSc, BA, or RN equivalent) in biological or science-related field or equivalent experience

Prior Experience

• At least 5 years’ experience as a Clinical Research Associate with a sound track record in managing clinical trial sites
• Experience in monitoring oncology phase I-III studies (at least 3 years of oncology experience)

Skills and Competencies

• Thorough knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements.
• Highly effective multitasking and execution skills.
• Excellent interpersonal skills, including communication, presentation, persuasion, and influence.
• Excellent organizational skills, including efficiency, punctuality, and collaboration in a team environment.
• Knowledgeable in the identification, anticipation, and reporting to appropriate management problems relating to study conduct, and highly effective in developing solutions to those problems
• Effective knowledge of the drug development process and the Theradex organizational structure
• Strong communication skills: verbal and written
• High level of proficiency in Microsoft Outlook, Word and Excel

Additional Requirements

• This position involves international and/or national travel as needed to meet study requirements. Ability to travel domestically and/or internationally and may involve overnight stays. Travel requirements are up to 70% in the UK
• Valid Driver’s License and Passport preferable.
• Successfully pass background clearance checks.
• Fluent in English and (for EU/UK) preferably at least one other European language, as applicable.

• Must be confident in applying RECIST criteria in oncology trials. 3 years experience of using RECIST in more than one study.

• Candidates should have experience in monitoring Phase I–III oncology studies? at least 3 years of oncology experience in more than one oncology study.

What we offer:

We offer a friendly and supportive culture that puts people first. We provide a competitive compensation and benefits package including 6% pension contribution, private medical insurance, sick pay and income protection insurance, life assurance and eyecare voucher scheme.

This job does not offer company sponsorship

Theradex is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment.

We offer a friendly and supportive culture that puts people first.