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Ref: CG/115 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. |
