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Clinical Research Monitor

  • Job reference: 926752
  • Location: Leeds, West Yorkshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 24/07/2019

Orion Group are looking for a Clinical Research Monitor for our multinational medical devices client looking for someone to cover the North of England and Scotland. on an initial 12-month contract with the potential to extend.

Job Purpose
Provide support to the implementation of the clinical research operations programme for all appropriate therapeutic areas for the client 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 wellbeing of all trial participants, and good/rigorous scientific practice. Successful planning and execution of monitoring of clinical research projects has a direct bearing on present and future profitability and the maintenance of good relationships with key customers. Accountable for ensuring that the Company's legal and ethical standards of Good Clinical Practice and the Helsinki declaration are maintained in respect of clinical research studies.

Main Responsibilities of the role

  • 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
  • Maintain the highest ethical, clinical and scientific standards ensuring both the safety and wellbeing of all trial participants and good/rigorous scientific practice
  • 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
  • Keep abreast of developments in clinical research and the clinical literature in therapeutic areas of responsibility
  • 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
  • Monitor defined clinical studies in accordance with Good Clinical Practice requirements and provide regular feedback to company personnel on the progress of trials
  • Administer the inventory of Investigational Products and control the issue of investigational products to approved sites where necessary
  • 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
  • Maintain compliance with Company SOPs
  • Maintain a high standard of housekeeping and filing accuracy
  • Presentations on clinical study progress

Desired Experience and Background of the successful candidate

  • 1st Degree in Life Sciences, Health Sciences or related field to Biomedical Engineering or equivalent combination of education and experience
  • 5+ years' experience of clinical trials monitoring in a medical company preferably with medical devices
  • 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
  • Be able to use personal computer and general office equipment
  • Problem Solving: Independent judgement is employed in problem solving for project management with supervision
  • Decision Making: Decisions are made subject to established company, departmental and government policies and regulations with supervision
  • Degree of Responsibility: Instrumental in meeting departmental objectives. Must be highly responsible and capable of seeing each project to its conclusion
  • 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 and the client. 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
  • 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
  • Adverse Work- Environmental Conditions: - Frequent visits to hospitals
  • Physical: - Frequent travel throughout the UK, possibly Europe

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.