Senior Clinical Research Associate (UK Contractor)

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.

 

What You'll Do

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 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.

 

We are hiring a Full time Freelance SCRA/CRA-II  in the UK, preferably London area on a 6 month contract (Inside IR35).

 

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

• Assist in the preparation of project specific materials e.g., status reports, newsletters, templates, study manuals/binders, etc.
• Maintain an awareness of the literature on cancer therapy, clinical trial design and conduct, and good clinical practice.
• Collaborate with other members of the project team to meet Sponsor, Protocol and Theradex objectives of Regulatory Readiness including contract and budget negotiations, as required.
• Establish and maintain effective, routine communications with study sites , providing timely study updates and support to sites.
• Establish and maintain effective, routine communications with the internal project team, providing timely project team updates on site related issues.
• Responsible for assisting in the preparation of the Investigator and Sponsor files with essential documents for the initiation of sites participating in clinical studies.
• Maintain up-to-date site information (including all contact details and distribution lists for reports and clinical supplies).
• Performs ongoing management of essential regulatory documentation at the outset and across the lifespan of a study
• Performs quarterly QC of assigned studies/sites in the eTMF according to Theradex Oncology SOP.
• Performs study tracking via CTMS, investigator site file tracker (if utilized) and/or sponsor designated system to ensure that the study files are current, accurate and complete.
• Ensures protection of subjects, subjects’ rights, and the integrity of data through adherence to Good Clinical Practice, applicable regulatory requirements, Standard Operating Procedures, and protocol compliance.
• Participate in the conduct of pre-qualification, initiation, routine monitoring, remote monitoring, and close-out visits in accordance with the relevant SOPs
• Proactively identify and resolve potential site and study issues.
• Identify and escalate data quality issues to ensure clinical data integrity
• Provide support to project management via ongoing project reports and updates.
• May be responsible for supporting multiple studies simultaneously

 

What You Need

Level of Education:

•  At minimum, Bachelor's degree (BSc, BA, or RN equivalent) in biological or human 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 on-site monitoring oncology early phase studies
• CRO/Pharmaceutical industry experience

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. 

• 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.

Skills and Competencies to be demonstrated:

• 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
• Candidate must be fluent in English.

What we offer:

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

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.