An established biotechnology company is advertising a vacancy for a Clinical Research Associate position based in Cheshire. The company develops next-generation, patient-specific therapeutics that allow scientists to combat cancer without harming healthy tissues. This is an exciting opportunity to work with a dynamic and revolutionary organisation.
- Identifies, evaluates, and recommends potential investigators/sites on an ongoing to assist in the placement of planned clinical studies with qualified investigators.
- If required, prepares, coordinates, and presents at Investigator meetings and other study trainings
- Maintain up to date self-training e.g. ICH GCP and flag new/changes to site and clinical operations team.
- Facilitates the Regulatory Compliance audit process, as needed.
- Provides monitoring assistance to site monitor colleagues, as requested, in addition to serving as a mentor to other colleagues as assigned.
- Uses multiple technologies to foster, maintain, and enhance open communication.
- Available for travel up to 60% of the time, including overnight stays as necessary
- Any other ad-hoc tasks as required.
- The post-holder will be responsible for adhering to all health and safety guidance, provided by the Company.
Skills and Requirements:
- Bachelor's degree (BSc, BA, or RN equivalent) in biological or science-related field is essential
- Previous small pharmaceutical/biotech experience preferred.
- Minimum of 3-5 years' monitoring experience, working as a CRA.
- Experience in monitoring oncology early phase studies.
- Experience with ATIMPs an advantage.
- Strong clinical, technical or disease area expertise.
- Knowledge of medical terminology and clinical patient management.
- A valid driving license.
- Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and service providers.
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements.
- Preferably experienced with the use of eCRFs.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Joshua Godden at +44 2038540101 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.