Clinical Research Associate
Rob Angrave is recruiting for a Clinical Research Associate to join a company in the clinical research industry at their site based in Cheshire on a permanent basis.
A Clinical Research Associate will be involved in all stages of clinical trials, including the identification of an investigational site and setting up, initiating, monitoring and closing down a trial.
I am looking to recruit an experienced CRA that will join an exciting company who primarily focus on early stage oncology studies.
- 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
- Manage regulatory authority applications and approvals, obtaining regulatory documentation for successful implementation, monitoring and evaluation of clinical trials
- Set up trial sites, ensuring that each centre has the necessary trial materials
- Work with the study start up group and site staff to obtain regulatory (IRB/IEC) approval of study specific documents
- 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
- Perform study initiation activities, reviewing with the site personnel, the protocol, regulatory issues and study procedures
- 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
- Ensure adherence to Good Clinical Practice, investigator integrity and compliance with all study procedures through onsite monitoring visits
- Perform validation of study data against source documentation as required by the sponsor and prepare monitoring reports and letters as necessary
- Document accountability, stability and storage conditions of clinical trial materials as required by the sponsor
- Perform investigational product inventory and ensure return of unused materials to designated location/verify destruction as required
- Review the quality and integrity of clinical data through inhouse review of electronic CRF data and on-site source verification
Minimum Requirements - Education and Experience
- Degree or equivalent qualification in life sciences or allied discipline with proven experience in the field of monitoring ideally early phase Oncology, Rare Diseases, Cell and Gene Therapies
- Sound knowledge of clinical research process and medical terminology
- Good understanding of electronic data capture, including basic data processing functions
- Good understanding of current ICH-GCP (R2) guidelines applicable to the conduct of clinical research
- Willingness and ability to travel domestically (and occasionally internationally) as required
- Proven ability to lead and influence at study sites and in a fast paced and collaborative environment
If you are looking for a new role where you can join a company that will enable to have more of a hands on experience, work on exciting and leading clinical trials.
For more information or to apply for this position, please contact Robert Angrave on 01246 457733 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 47394 in all correspondence.