Russell Oakley is currently looking for a Clinical Research Associate for an academic CTU based in Manchester. The role will be a contract position which at this stage may be for somewhere in the remit of 3-6 months.
Clinical Trials Monitoring
· Responsible for the development and implementation of monitoring plans with the Clinical Trials Monitor Team Lead, and CTU trial team, for trials supported by the CTU.
· Perform both investigator site monitoring visits and remote monitoring activities for academic led clinical trials, including source data verification, to ensure sites are compliant with the trial protocol and other regulatory and quality standards.
· Ensure that all monitoring visits with investigator research teams are scheduled and delivered according to agreed monitoring plans, ensuring efficient and effective scheduling of visits.
· Assist and accompany trial sponsors in conducting participating site audits.
· Develop monitoring reports and liaise with investigator research teams and CTU teams to follow up and close out the actions identified during monitoring visits.
· Work closely with the other CTU teams, to deliver specific clinical trials, to the service standards and timelines specified in grant applications and contracts.
· Maintain a thorough and up-to-date understanding and working knowledge of legislation, guidance and local and national initiatives relating to clinical research, in particular GCP and DoH Research Governance Framework, and applying this knowledge through working practices on the projects that you monitor.
· Establish and maintain professional relationships with collaborators including commercial partners, clinicians, academics, and relevant laboratory and research staff at centres participating in specific projects.
· Work closely across CTU internal teams to ensure that a high quality service is delivered seamlessly to external partners and internal colleagues.
· Assist with preparation for and presentation of internal and external reviews/inspections
(e.g. MHRA, in-house audits etc.).
The ideal candidate will have:
· Educated to degree level in a scientific discipline or relevant experience in scientific or medical research
· Experience in coordination or monitoring of clinical trials
· Ability to write and analyse reports, interpreting and presenting data clearly
· Excellent organisational and project coordination skills
· Excellent interpersonal skills
· Good working knowledge of databases, spreadsheets, word processing, internet/email
· Excellent communication skills, both written and verbal
· Understanding of academic research and related clinical/medical terminology
· Working knowledge of GCP guidelines and EU clinical directives
· Understanding of Data Protection Act and confidentiality
· Ability to work to tight and/or unexpected deadlines
· Ability to work independently and as part of a multidisciplinary team
· Willingness and ability to travel within the UK, providing sufficient notice is given
· Post-graduate qualification or similar experience in academic or NHS research
· Previous experience of working in the University/NHS environment
· Experience of coordinating or monitoring multisite national or international clinical trials
· Understanding of clinical trial audit and inspection processes
· Evidence of continuing professional development (CPD)
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 CL43927 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical and Technical Recruitment)
- Contact: Russell Oakley
- Phone: 01246 457733
- Reference: CL43927
- Posted: 6th December 2018
- Expires: 3rd January 2019