Clinical Reasearch Associate
Russell-Taylor Group is delighted to be working with a UK leading medical devices company. The client provides extensive expertise in research, development, design, manufacture, and marketing to others in the medical field.
The client is looking to appoint a Clinical Research Associate to your join their team. The successful candidate will be reporting to the Clinical Trials Manager.
Location : Leeds
Salary: GBP38,250 - GBP45K (dependant on experience)
Start date : ASAP
Working week : Mon - Fri (hours TBC)
Key Responsibilities:
Organise and monitor clinical investigations, delegating to third parties such as Clinical Research Organisations (CROs) and Clinical Trials Units (CTUs) as required. Co-ordinate studies with host centres, surgeons and administrators and ensure that contracted deliverables are delivered on time and to correct quality.
Develop and write clinical investigation protocols, clinical investigation reports, case report forms (CRFs), investigator brochures and other clinical trial documentation. Ensure that processes for contracts and study set-up are followed without delay.
Manage ethical approval processes and regulatory authority applications/approvals. Monitor relevant external parties to ensure these progresses smoothly.
Identify and assess the suitability of investigators and facilities to use as the clinical trial site.
Be responsible for site set up, training, monitoring and close out.
Be accountable for devices and inventories.
Verify and review adverse events, serious adverse events, concomitant medications, and corresponding illnesses to confirm accurate data reporting in accordance with the protocol.
Archive study documentation and correspondence.
Manage data including arranging statistical analysis.
Provide an up-to-date overview on a weekly basis of progress on all of the above and act promptly on any Amber/Red status activities.
Assist in the development and drafting of trial methodologies (Standard Operating Procedures).
Essential Experience, Knowledge and Qualifications
Degree in science, clinical or health-related field or a licenced health-care professional such as registered nurse; or equivalent work experience required.Working knowledge of EU Directives/UK regulations/ISO 14155 regulations, device development and clinical monitoring procedures.
Desirable Experience, Knowledge and Qualifications
Experience of managing clinical investigations.Project or Programme Management qualifications/training.
Experience in medical devices and knowledge of ISO 13485:2016
Working knowledge of US regulationsEssential Skills and Behaviour
Good organisational skills and attention to detail.
Excellent interpersonal skills and the ability to work as part of a team.
Excellent verbal and written communication skills and presentation skills.
Willing to travel more than 50% of the time.Values
Integrity
Quality
Flexibility
Creativity
RespectIf interested in this exciting opportunity please don't hesitate to contact Russell-Taylor Group (Manchester) or alternatively apply.
Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our Privacy Policy h t t p s : / / w w w . r u s s e l l - t a y l o r . c o . u k / p r i v a c y - p o l i c y on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or the GDPR please contact us on h u s s e l l - t a y l o r . c o . u k
The client is looking to appoint a Clinical Research Associate to your join their team. The successful candidate will be reporting to the Clinical Trials Manager.
Location : Leeds
Salary: GBP38,250 - GBP45K (dependant on experience)
Start date : ASAP
Working week : Mon - Fri (hours TBC)
Key Responsibilities:
Organise and monitor clinical investigations, delegating to third parties such as Clinical Research Organisations (CROs) and Clinical Trials Units (CTUs) as required. Co-ordinate studies with host centres, surgeons and administrators and ensure that contracted deliverables are delivered on time and to correct quality.
Develop and write clinical investigation protocols, clinical investigation reports, case report forms (CRFs), investigator brochures and other clinical trial documentation. Ensure that processes for contracts and study set-up are followed without delay.
Manage ethical approval processes and regulatory authority applications/approvals. Monitor relevant external parties to ensure these progresses smoothly.
Identify and assess the suitability of investigators and facilities to use as the clinical trial site.
Be responsible for site set up, training, monitoring and close out.
Be accountable for devices and inventories.
Verify and review adverse events, serious adverse events, concomitant medications, and corresponding illnesses to confirm accurate data reporting in accordance with the protocol.
Archive study documentation and correspondence.
Manage data including arranging statistical analysis.
Provide an up-to-date overview on a weekly basis of progress on all of the above and act promptly on any Amber/Red status activities.
Assist in the development and drafting of trial methodologies (Standard Operating Procedures).
Essential Experience, Knowledge and Qualifications
Degree in science, clinical or health-related field or a licenced health-care professional such as registered nurse; or equivalent work experience required.Working knowledge of EU Directives/UK regulations/ISO 14155 regulations, device development and clinical monitoring procedures.
Desirable Experience, Knowledge and Qualifications
Experience of managing clinical investigations.Project or Programme Management qualifications/training.
Experience in medical devices and knowledge of ISO 13485:2016
Working knowledge of US regulationsEssential Skills and Behaviour
Good organisational skills and attention to detail.
Excellent interpersonal skills and the ability to work as part of a team.
Excellent verbal and written communication skills and presentation skills.
Willing to travel more than 50% of the time.Values
Integrity
Quality
Flexibility
Creativity
RespectIf interested in this exciting opportunity please don't hesitate to contact Russell-Taylor Group (Manchester) or alternatively apply.
Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our Privacy Policy h t t p s : / / w w w . r u s s e l l - t a y l o r . c o . u k / p r i v a c y - p o l i c y on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or the GDPR please contact us on h u s s e l l - t a y l o r . c o . u k