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Clinical Research Associate

  • Job reference: 921194
  • Location: Inverness, Highlands
  • Salary: Negotiable
  • Job type: Contract
  • Sector: R&D - Clinical & Non Clinical, Life Sciences
  • Date posted: 15/08/2018

OrionGroup are looking for a Clinical Research Associate for our multinational medical devices client based in the Highlands, northern Scotland on an initial 12-month contract


Job Outline
Provide support to the implementation of the clinical research operations programme for Clinical Operations in accordance with all applicable regulations for Medical Devices. Plan & implement a programme of monitoring for all international regulatory and other 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.

Main Responsibilities of the role

  • Provide support to Clinical Operations for agreed projects 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 well being of all trial participants and good/rigorous scientific practice.
  • Keep abreast of international legislation and other requirements concerning clinical research. Prepare and submit submissions or amendments for the approval of clinical investigations to regulatory authorities and ethics committees.
  • 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 Operations team management.
  • Maintain compliance with Company SOPs.
  • Maintain a high standard of housekeeping and filing accuracy.

    Ideal Background and Skillset of the successful candidate:
  • 1st Degree in Life Sciences, Health Sciences or related field to Biomedical Engineering or equivalent combination of education and experience.
  • 1-2 years (senior 3-4 years) experience of clinical trials management 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.
  • 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 company. 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. Consultants, 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.


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.