Lead CRA - Early Phase Oncology

Job title : Lead CRA - Early Phase Oncology
Location : England
Job type : Permanent
Salary : £45000 - £55000 per annum
Contact name : Crystal Leung
Contact email : crystal.leung@seclifesciences.com
SEC Life Sciences is working with a CRO who seeks a Lead CRA with line management experience for an early phase (I, II) oncology study. The candidate will be responsible for monitoring clinical trials and ensuring investigators are conducting research within the requirements of the clinical protocol and ICH-GCP.

There will be involvement in all stages of clinical trials, including the identification of an investigation site, set-up, initiation, monitoring, and closing of a trial.
This role reports to the Associate Director of Clinical Operation and works closely with the project team to ensure compliance with appropriate regulations and guidelines throughout the trial. They will ensure the rights and safety of human subjects involved in a clinical study are always.

Role Brief

-Participate in the investigator recruitment process, performing initial qualification visits of potential investigators and evaluating the capability of the site to successfully manage and conduct the clinical study, both clinically and technically
-Work with the study start up group to coordinate activities with the site in preparation for the initiation of studies and with site staff to obtain regulatory (IRB/IEC) approval of study specific documents
-Manage regulatory authority applications and approvals, obtaining regulatory documentation for successful implementation, monitoring and evaluation of clinical trials
-Set up trial sites and ensuring that the necessary materials are available
-Ensure study documentation is maintained in the Investigator Study File and where necessary ensure relevant documents are transferred or copied to the (electronic) Trial Master File
-Provide training on completion of the eCRF; monitoring activities and study close out activities
-Train site staff on the EDC system and verify site computer system
-Monitor trials throughout their duration, conducting periodic site file audits to ensure compliance with GCP and the company's standard operating procedures
-Ensure adherence to Good Clinical Practice, investigator integrity and compliance with al study procedures through on-site monitoring visits
-Mentor new CRAs
-Assist with final data review and query resolution through to database lock
-Act as primary contact between the CRO and the investigator, coordinating correspondence and ensuring timely transmission of clinical data with the study site and technical reporting as necessary
-Develop and review protocols, eCRFs, study manuals, and other related documents as requested by the Clinical Trial Manager
-Once a month presence in office is required; travelling to sites required at 2 days a week

Experience & Qualifications

-Min. 5 years as a CRA with Oncology experience
-Line management experience a (min.) of 5-people team
-Degree or equivalent qualified in a health or biologic science
-Proven experience with monitoring early phase Oncology, Rare Diseases, Cell, and Gene Therapies
-Good understanding of current ICH-GCP (R2) guidelines applicable to the conduct of clinical research
-Good understanding of electronic data capture, including basic data processing functions
-Proven ability to lead and influence in a face paced and collaborative study environment

To apply, please send your CV to Crystal at crystal.leung@seclifesciences.com briefly outlining your experience and suitability for the role.

SEC Life Sciences is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, bio-pharmaceutical, biotechnology, and medical device companies.