Russell Oakley is currently recruiting for a Senior Clinical Research Associate who can make a significant contribution to the continued growth and success of a medical devices company based in Stirling in the central belt of Scotland.
Working as part of the Clinical team you will have significant clinical project responsibility for planning and conducting all clinical studies to support product development, regulatory submissions and post-market evaluation for In Vitro Diagnostic products on the company Platform. Studies will range from single site to international multi-centre so some travel will be required. The role will plan, implement, monitor and review studies in line with the business plan whilst meeting all ethical, regulatory and scientific needs. You will also be charged with ensuring the quality and integrity of data, compliance with relevant business processes and regulatory requirements and study completion on time and within budget.
Technical lead for ensuring the clinical trial study design meets the needs of the product launch plan.
Identify appropriate clinical sites and manage effective clinical relationships. Liaise with the Principal Investigator and clinical operations staff as required.
Organise/prepare/attend investigator meetings as required.
Prepare, edit, review and submit clinical documentation according to study needs including but not limited to:
Protocols & Protocol Amendments
Patient Information Sheets
Complete and compile all necessary research, documentation and information to gain appropriate regulatory and ethical committee approval where required e.g IRAS, HRA and R&D submissions.
Clinical lead to ensure studies are planned, implemented, conducted, monitored and reported according to all business processes.
Monitor clinical trials to ensure compliance to the study protocol, clinical business processes, applicable regulations and the principles of ICH-GCP, typically 50% of active sites.
Management of clinical sites to ensure protocol, source data verification and CRF compliance.
Lead pre-study initiation, interim monitoring and close out visits as required.
Prepare, monitor and report clinical study budgets.
Provide continuous up-date of trial status to relevant key stakeholders, identifying potential delays that may impact product launch.
Train external clinical users on the LumiraDx Platform and other relevant products.
Comply with appropriate ICH GCP standards and relevant sections of the IVD Directive and US Code of Federal regulations, Title 21 (21 CFR).
Up-date and review business processes and clinical procedures to meet regulatory and business needs.
Responsible for ensuring that all clinical trial master files are "audit ready" at all times.
Communication & Liaison
Establish and manage effective clinical and/or supplier relationships.
Understand the relevant clinical requirements; liaise with cross functional team leaders to provide robust clinical outcomes.
Excellent communication skills, especially written and verbal to ensure all key stakeholders are kept current and effective relationships (both internally and externally) are built.
Be solution focused and work as part of a multidisciplinary team to proactively meet and balance the business objectives and clinical requirements.
May have line management responsibility for junior staff.
Train others, internally and externally in areas of expertise.
A Degree in Life Sciences, Health Sciences or related field, or professional qualification such as nursing, or in-depth experience in performing a Clinical Research Associate role preferably with Medical Devices or In Vitro Medical Devices.
Work experience within either a hospital, medical/research centre environment, Contract Research Organisation or Pharmaceutical company.
Proven track record of adherence to ICH-GCP and applicable local regulatory requirements during the conduct of clinical trials.
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 ref CL41172 on application.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Posted: 14th February 2018
- Expires: 14th March 2018
- Reference: CL41172