CK Clinical are recruiting for a Senior CRA to join a diagnostic healthcare company in the medical device industry at their site based in Stirling on a full time permanent basis.
Senior CRA Role: The main purpose of the role will be to:
- Be the technical lead for ensuring clinical trial study design meets the needs of the product launch plan.
- Identify appropriate clinical sites and liaise with principal investigator and clinical operations staff as required.
- Organise, prepare for and attend investigator meetings as and when required.
- Prepare, edit, review and submit clinical documents in line with study such as ethics submissions, R&D applications, protocols and amendments, CRFs, Patient information sheets, consent forms and various training materials.
- Monitor clinical trials to ensure compliance to the study protocol, applicable regs and principles of ICH-GCP.
- Lead on prestudy initiation, interim monitoring and close out visits as required.
Your Background: In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Degree level educated (life sciences).
- Significant experience working with NHS/research, CRO or pharma industry.
- Prior in depth experience working as a CRA, preferably within medical devices.
- Good knowledge of ICH-GCP and applicable local regulatory requirements for conduct of clinical trials.
- Able to carry out visits independently - pre study initiation, interim monitoring and close visits.
The Benefits: This is an excellent opportunity to join a growing company as it develops new and exciting products that it is taking to market.
Apply: For more information or to apply for this Senior CRA position, please contact Rob Angrave on 01438 870022 or email firstname.lastname@example.org, quoting job ref 48420.
It is essential that applicants hold entitlement to work in the UK.