NSQF-Clinical Research Associate.pdf

Clinical Research Associate

  • Job DescriptionClinical Research Associate supports clinical trial activities, carries out reporting and documentation of research activities and coordinates with team members and CRO.
  • CodeLFS/Q0503
  • SectorLife Sciences
  • NSQF LevelLevel 5
  • Notional Hours270
  • Accrediting BodiesLife Sciences Sector Skills Council
  • Certifying BodiesLife Sciences Sector Skills Council
  • Proposed Occupation

    Clinical Research Associate also known as Clinical Trial Monitor is a job role under Research and development occupation. The individual is responsible for supporting and monitoring clinical trial activities. carries out reporting and documentation of research activities and coordinates with team members and Contract Research Organization. The job requires individual to use the knowledge of Life Sciences Industry. drug development concepts and process. knowledge of clinical research phases and monitoring and reporting procedures and knowledge of pharmaceutical sciences and medical terminology and human anatomy. The individual uses skills like planning and organizing. critical and analytical thinking. problem solving. customer centricity and decision making. The individual is responsible for own work and learning and has some responsibility of others work and learning.

  • International Comparability

    While preparing the NOSs, a detailed secondary desk research was conducted. The European, South African and Australian NOSs were referred to. The relevant International NOSs for the job role are listed below for reference: UK NOS • COGLS217 Drawing blood samples from patients for investigation in life sciences and related industries • SFHPHARM23 check documentation and materials • COGLS2 Maintain effective and efficient working relationships • COGPIO3.2 control emergencies • COGLS201 Follow health and safety procedures in life sciences • COGLS301 Maintain health and safety in life sciences Switzerland NOS • Refer page no.196, Unit Group 3212, page no. 142 Unit Group 2240, page no.202 Unit Group 3252, page no. 204 Unit Group 3256; International Standard Classification of Occupations ILO Geneva, ISCO–08 Volume I (http://www.ilo.org/wcmsp5/groups/public/---dgreports/---dcomm/--- publ/documents/publication/wcms_172572.pdf) Australia NOS • Conduct a clinical measurement • Perform basic clinical procedures • Communicate workplace information • Participate in work teams and groups South Africa NOS • Interact with clients in a health and pharmaceutical environment • Act in accordance with ethical and legal codes of pharmaceutical representation and the laws of the country • Apply ethical and legally compliant behaviour in pharmaceutical and health environments

  • Progression Pathway

    Upward progression:  Lead Clinical Research Associate  Clinical Data Validator. Lateral/ Horizontal progression: Clinical Research Coordinator

  • Qualification File NSQF-Clinical Research Associate.pdf
  • Supporting Documents
  • Formal structure of the qualification
    Title of unit or other component Mandatory/ Optional Estimated size (Hours) Level
    LFS/N0508 To support clinical trial activities Mandatory 100 Level 5
    LFS/N0509 To carry out reporting and documentation for clinical trials Mandatory 80 Level 5
    LFS/N0101 Maintain a healthy safe and secure working environment in the life sciences facility Mandatory 45 Common across level 2-7
    LFS/N0510 Co-ordinate with team members and site Mandatory 45 Level 5