Lead Clinical Research Associate - Up to £42k- West Midlands
- 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
- Ensure overall integrity of clinical studies and adherence to relevant regulatory standards, ICH GCP, protocol and company SOPs.
- Provide leadership and co-ordination for ongoing-clinical studies in the UK working with all internal and external stakeholders to ensure timely completion and full compliance with appropriate protocols and ethics.
- Participate in the identification and selection of investigators and clinical sites.
- Ensure that key study documents including study protocol (with CRM support), informed consent forms, case report forms, study specific and company SOPs, investigator brochure and other study specific documents are developed.
- To prepare the necessary study ethics, R&D, regulatory and site specific submission packages, as required.
- To ensure consistency across sites in multi-centre studies and to prepare, organize and present at investigator meetings to assist the CRM.
- Oversee clinical studies ensuring scope is agreed and understood, costs are managed in line with budget and objectives are achieved to meet project timelines.
- Oversee clinical studies, providing for investigator and staff training.
- Perform on-site visits and monitoring activities as required, 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 and to assist other CRA's with issues on sites and to handle/manage difficult situations.
- Act as a liaison between the company and study site personnel and be available 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.
- 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.
- Provide recommendations regarding site-specific actions and use judgement and experience to assess ability of site staff accordingly.
- Stand in for CRM as required.
- 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.
- Maintain good working knowledge of ICH GCP as well as applicable regulations.
The Ideal Person:
- Degree in Life Sciences, Nursing or equivalent.
- Minimum of 5 years' clinical research experience as a CRA preferably within the medical device or cardiology sector and at least 1 year as Project Lead/Lead Clinical Research Associate or Team Manager.
- In depth knowledge of ICH-GCP and a working knowledge of ISO 14155.
- Experience of protocol design in accordance with ISO 14155 and submission to relevant ethics committees and other regulatory stakeholders.
- Proactive communication skills with a collaborative and inclusive personal style at home in a small and dynamic team as well as in front of a larger professional audience.
- Good project management skills with the ability to initiate action and deliverables through others in the clinical team.
- The ability to interpret data on project issues and make good business decisions, with support from experienced team members and management.
- 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.
About On Target
On Target Recruitment is one of the UK's leading specialist recruitment agencies. Our consultants specialise in sales, technical and commercial jobs in the Engineering, Construction, Medical, and Business Solutions sectors. We place all levels of personnel, up to Director across the UK and internationally.