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Clinical Research Associate - Cardiology Diagnostics - £27-£33k

The Company:

  • An exciting opportunity to join an innovative British company developing diagnostics technologies for acute medical settings

  • A fantastic opportunity to join a start up medical technology company in development stage so the sky really is the limit as far as how far you can progress within the company

The Role:

  • Ensure overall integrity of clinical studies and adherence to relevant regulatory standards, ICH GCP, protocol and company SOPs.

  • Participate in the identification and selection of investigators and clinical sites

  • Assist in preparation of study protocol, Investigator's Brochure (if applicable), case report forms, informed consent and other specialized documents for clinical investigations

  • Participate in the preparation of submissions for ethics committee approval and where appropriate, MHRA approvals

  • Initiate clinical investigations, providing for investigator and staff training

  • Perform on-site visits and monitoring activities in accordance with the protocol, company SOPs, ICH GCP guidelines and other applicable regulatory requirements, and complete appropriate documentation (confirmation, follow-up letters, visit reports etc.) as required

  • Evaluate overall performance of site and site staff

  • Ensure compliance and understanding of study requirements by site contacts

  • Apply judgement and knowledge to independently resolve site issues

  • Act as a liaison between the company and study site personnel and be able to respond to site concerns and questions

  • Review and verify case report forms and other clinical data for completeness and accuracy

  • Monitor patient safety, identify and address any protocol deviations

  • Assure ongoing documentation and reporting of adverse events to sponsor and ethics committee

  • Generate queries and manage resolutions with site personnel

  • Interpret data to identify protocol deviations or major risks to data integrity

  • Obtain, review and process regulatory and administrative documents from investigator sites

  • Maintain project tracking systems as required

  • Participate in organisation of investigator meetings

  • Understand project scope, budgets and timelines and be able to provide input and manage objectives to meet required project timelines

  • Provide recommendations regarding site-specific actions and use judgement and experience to assess ability of site staff accordingly

  • Assist regulatory affairs in preparation of safety, efficacy and performance summaries for regulatory submissions and annual reports

  • Work with other staff on training, guidelines and processes

The Ideal Person:

  • Degree in Life Sciences, Nursing or equivalent

  • Minimum of 3 years' clinical research experience as a CRA/CTA preferably within the medical device or cardiology sector

  • In depth knowledge of ICH-GCP and a working knowledge of ISO 14155

  • Motivated and organised with excellent interpersonal and communication skills

  • Must be able to effectively manage resources and be able to prioritise and deliver a number of concurrent projects whilst working in a team and independently

  • A working understanding of Microsoft Office suite

  • Must have a current driver's licence

  • Must be available to travel nationally (up to 40%) and where applicable internationally

Consultant: David Gray

Candidates must be eligible to work and live in the UK.

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