Corin currently have the following vacancies:

JOB TITLE: Product Development Draughtsperson

DEPARTMENT: Product Development

LOCATION: Cirencester

A vacancy exists for a Product Development Draughtsperson reporting to the Product Systems Engineer in Product Development.

Job Specification

Responsibilities will include:

• Produce 2D drawings and 3D CAD models of implants and instruments as directed by the Product System Engineer.
• Generate full design package to facilitate transfer to production.
• Ensure the correct management of design control and design risk through the use of the quality system.
• Provide input into the design of implants and instrumentation.
• Support QA/RA in technical investigations of complaints and in compilation of technical sections of regulatory submissions.
• Liaise with Manufacturing and Production Engineering on device specification.

Key Skills:

• Ability to use 3D and 2D CAD (e.g. Solid Edge).
• High level of computer literacy.
• Good time management skills.
• Ability to produce high accuracy work in a timely manner.

Person Specification

• ONC or equivalent in a relevant subject such as Mechanical Engineering, or Product Design or demonstrate a similar level of education or experience.
• Ability to work in a draughting and design role.
• An understanding of the manufacturing sector is desirable, as is an understanding of working in a regulated environment.
• Highly motivated and be capable of working on specified tasks with minimum of supervision.
• Work well as a member of one or more teams.
• Good written and verbal communication skills.
• Ability to remain organised and track multiple tasks.
• Ability to focus on the detailed elements of the work and to check the quality of their own output.

For further information regarding this post or for an informal discussion, please contact Paul Mayon, Product Systems Engineer.

Applications to: Jane Iles, HR Assistant.

Closing date for applications: 28th November 2008.

This vacancy is open to internal and external candidates.

JOB OPPORTUNITY

JOB TITLE: Clinical Research Associate

DEPARTMENT: Regulatory Affairs

LOCATION: Cirencester

The Clinical Research Associate (CRA) performs all assigned activities and operational processes associated with clinical investigation/study management (coordination and supervision) including design, implementation and conduct of clinical investigations. The primary focus of the position is to assure compliance with Corin sponsored clinical investigation protocols, company SOPs, EU and other national regulations/guidance and GCP. The CRA performs responsibilities under the supervision of the Clinical Research Manager with minimal supervision.

Job Specification

Responsibilities will include:

• Contribute to development of clinical protocols, case report forms, regulatory documents and other study materials for clinical investigations.
• Obtain ethics committee approval and where appropriate, MHRA approvals, to permit study commencement.
• Ensure clinical studies are conducted in accordance with ISO 14155.
• Conduct study start-up activities, site initiation, site personnel and monitor training.
• Conduct investigational site visits (pre-study, initiation, interim or close-out) as necessary.
• Provide training of investigators/study coordinators and guidance on identification of corrective actions as appropriate.
• Assist with the timely collection, maintenance, and control of clinical investigation documentation.
• Assist with identification and resolution of data discrepancies.
• Develop expertise in regulations for all types of studies.
• Participate in the creation, review, and approval of departmental operating procedures.
• Perform literature review as part of the study protocol design
• Provide regular updates to the Clinical Research Manager on relevant clinical studies.
• Perform basic regulatory reports and statistical analyses (e.g. Kaplan Meier) to calculate survivorship data.
• Assist surgeons in the writing of clinical papers for journal or in-house publication.
• Undertake other related duties as required.

Person Specification

Required qualifications: degree or equivalent combination of education and relevant experience; medical device or pharmaceutical experience with CRO, hospital/health care provider or industry; basic understanding of Good Clinical Practices; knowledge of regulatory requirements. Proficient in MS Office applications including MS Project, Excel, and Access. Ability to travel 30% of working time.

Preferred qualifications: first degree scientific discipline or equivalent. Preferred experience in orthopaedic or other medical device sector. Other skills to include: strong organisational skills; attention to detail; ability to multi-task; ability to manage multiple study sites and multiple studies; strong written and verbal communication and diplomacy skills; ability to prioritise workload; results oriented; ability to learn independently.

For further information regarding this post or for an informal discussion, please contact Lynda Unitt, Clinical Research Manager.

Applications to: Jane Iles, HR Assistant.

Closing Date for internal applications is 30th November 2008.