Role: Clinical Research Associate
Salary: Highly competitive
CPL Life Sciences is collaborating with a well-established UK research centre offering an opportunity to be a part of their cause as a Clinical Research Associate. They are focused on changing and saving lives by carrying out scientific research to help prevent, diagnose and treat cancer. The client offers a friendly and passionate working environment, supporting equality, diversity, inclusion and the well being of their employers. The successful applicant will be monitoring the drug development clinical trials at investigational sites all around United Kingdom, additionally they will be required to develop good relationships with investigators, scientists and site personnel to ensure that all clinical trials are performed ethically, efficiently according to budget and to time.
· Participating in study team meetings.
· Assisting in the preparation of Trial Master Files (TMFs), Investigator Trial Files (ITFs) and Pharmacy Files (PF).
· Reviewing draft protocols and protocol amendments, case report forms (CRFs), informed consent documents (ICDs), research ethics committee application using the most current system.
· Assisting with site selection, assessment and documentation of potential investigational sites through feasibility questionnaires and conducting pre-study visits.
· Organising, conducting and documenting site initiation visits.
· Providing training and support to site staff, new SRAs or other personnel.
· Ensuring sites comply with the clinical trial protocol, policies, SOPs, local regulations and work in accordance with ICH GCP, EU and UK legislation.
· Conducting Pharmacy visits, ensuring investigational medicinal product (IMP) is handled, stored, dispensed, reconciled and returned/destroyed according clinical trial protocol, SOPs and local policies.
· Working with Data Management to monitor patients and achieve key performance indicators including time to patient lock, time to database lock.
· Biological Sciences degree or equivalent nursing qualification/experience.
· Industrial experience of ICH/GCP, EU legislation and clinical trial methodology.
· Flexibility to travel on a regular basis.
· Oncology work experience.
· Early phase monitoring (non-healthy volunteers) clinical trials.
If you are looking for an opportunity to enhance your technical experience, broaden your career horizons and change the future apply today.
For more information contact me on the email followed: Georgia.email@example.com
Georgia Mouzouridou Resource Hub – Cpl Life Sciences
Phone: +44 (0) 118 9594 990
Address: R+, 2 Blagrave Street, Reading, RG1 1AZ