Associate Clinical Research Scientist
Are you an experienced Clinical Research Scientist? Are you looking to take on a new challenge with a leading Medical Devices Manufacturer? If so we are looking for individuals just like you!
We have an opportunity for a Clinical Research Scientist to join a leading client of ours to be responsible for supporting the Orthopaedic EMEA Marketing teams on projects.
Based in Leeds, our client would like you to work on a contract for 12 months initially, Monday to Friday; you will have the opportunity to be responsible for:
SUMMARY OF POSITION:
Provide support to the implementation of the clinical research operations programme for all appropriate therapeutic areas for Medical Devices in accordance with all applicable regulations for Medical Devices. Plan & implement a programme of monitoring for all international regulatory and post marketing clinical research studies and maintain the highest ethical, clinical and scientific standards ensuring both the safety and well being of all trial participants, and good/rigorous scientific practice.
a) Knowledge: 1. Minimum Education Requirements:
1st Degree in Life Sciences, Health Sciences or related field to Biomedical Engineering or equivalent combination of education and experience.
2. Minimum Experience Requirements:
5+ years experience of clinical trials monitoring in a medical company preferably with medical devices.
3. Minimum Skill Requirements:
Knowledge of clinical study design and management. Relevant experience in implementation of clinical research studies. Working knowledge of international regulatory requirements applicable to clinical research. Awareness of research ethics. Above average oral, written and communication skills.
4. Equipment or Machines Used:
Personal computer and general office equipment.
b) Problem Solving: Independent judgement is employed in problem solving for project management with supervision.
c) Decision Making: Decisions are made subject to established company, departmental and government policies and regulations with supervision.
d) Degree of Responsibility: Instrumental in meeting departmental objectives. Must be highly responsible and capable of seeing each project to its conclusion.
e) Extent of Confidentiality: Access to and knowledge of technical, clinical, and regulatory data on many products including adverse event data. Limited access to the research programmes, strategy and commercial data of other affiliates. Limited contact with competition, Government and Regulatory Bodies in situations where discretion and security are critical. Access to confidential clinical information and medical history of patients entered into clinical research programmes.
f) Interpersonal Contacts: Medical, health care and academic institutions e.g. Consultant surgeons, Senior Nursing staff and Heads of Department together with their teams. Hospital and Regional Ethical Committees. MHRA and other Competent Authority staff. Patients during clinical investigations. Clinical research and regulatory organisations. Competition through professional societies, meetings and conferences.
g) Adverse Work 1. Environmental
Conditions: - Frequent visits to hospitals.
- Frequent travel throughout the UK, possibly Europe.
1.Provide support to EMEA Monitoring Resource Manager and act as the lead monitor within the EMEA region. Provide feedback on current and best monitoring practice, procedural and regulatory compliance, and system adoption (e.g. electronic TMF and Clinical Trial Management System (CTMS)).
2. Perform monitor observation visits throughout the EMEA region and provide feedback to EMEA Monitoring Resource Manager.
3. Provide support to Clinical Trial Leader for agreed projects in the EMEA Clinical Research programme for the defined therapeutic area by monitoring and reporting on studies progress in accordance with all Corporate and Statutory requirements to agreed timescales.
4. Maintain the highest ethical, clinical and scientific standards ensuring both the safety and well being of all trial participants and good/rigorous scientific practice.
5. Keep abreast of international legislation and other requirements concerning clinical research. Prepare and submit submissions for the approval of clinical investigations to regulatory authorities and ethics committees.
6. Keep abreast of developments in clinical research and the clinical literature in therapeutic areas of responsibility.
7. Assist in the preparation of consent documentation where required for the proper scientific evaluation of new or existing products in accordance with all ethical and regulatory requirements for Medical Devices in respect of applicable European and International Medical Devices Regulations.
8. Monitor defined clinical studies in accordance with Good Clinical Practice requirements and provide regular feedback to company personnel on the progress of trials.
9. Administer the inventory of Investigational Products and control the issue of investigational products to approved sites where necessary.
10. Participate in project teams and build relationships with investigators, regulatory bodies and appropriate company personnel as required regarding clinical research issues, working as directed by Clinical Trial Leader & monitoring team.
11. Maintain compliance with Company SOPs.
12. Maintain a high standard of housekeeping and filing accuracy.
Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.
Candidates must be eligible to live and work in the UK.
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