Job Summary:
The Regulatory Affairs Officer will support the Regulatory Affairs Manager in ensuring effective oversight of study protocols, procedures, and adherence to approved quality systems and practices. The incumbent will report directly to the JCRC Regulatory Affairs Manager and collaborate closely with study teams, including Principal Investigators and Study Coordinators, to uphold regulatory standards and facilitate smooth study operations.
Key duties and responsibilities:
▪ Support development and quality control management of all essential regulatory documents.
▪ Review study regulatory files according to developed schedules.
▪ Conduct thorough review of study documents to detect non-compliances and support their resolution
▪ Maintain of all essential study documents in compliance with GCP standards, Sponsor requirements, JCRC policies, and guidance provided by study monitor.
▪ Review submission packages and facilitate submission to ethical and regulatory bodies.
▪ Participate in protocol team trainings and meetings
▪ Maintain research source and essential documents.
▪ Follow-up on any regulatory pending issues (submission/approvals).
▪ Maintain and track all research regulatory documentation, including staff training records in Human Subject Protection (HSP) and Good Clinical Practice (GCP), as well as current professional practice licenses and CVs
▪ Create and maintain electronic regulatory study binders
▪ Work with study teams on developing the study-specific consent procedures and S.O. Ps
▪ Review of Informed Consent documents
▪ Maintain the tracking system for submissions to ethical and regulatory bodies.
▪ Liaison with the study PIs and study coordinators, take the lead on communications and submissions to ethical, regulatory bodies and Sponsors
Qualifications, experience and knowledge required:
▪ A degree in Nursing or Bioethics or other health related field.
▪ At least 2 years' relevant experience in the health research sector.
▪ Knowledge of MS packages required.
▪ Maintain high level of personal integrity and reliability. Be willing to work extra/overtime hours as needed according to departmental workload.
▪ Knowledge of national and international research regulations/guidelines
▪ Knowledge of bioethics is desirable
▪ An individual with good communication and interpersonal skills, ability to pay attention to detail, multi –task and an excellent team player
Support development and quality control management of all essential regulatory documents. ▪ Review study regulatory files according to developed schedules. ▪ Conduct thorough review of study documents to detect non-compliances and support their resolution ▪ Maintain of all essential study documents in compliance with GCP standards, Sponsor requirements, JCRC policies, and guidance provided by study monitor. ▪ Review submission packages and facilitate submission to ethical and regulatory bodies. ▪ Participate in protocol team trainings and meetings ▪ Maintain research source and essential documents. ▪ Follow-up on any regulatory pending issues (submission/approvals). ▪ Maintain and track all research regulatory documentation, including staff training records in Human Subject Protection (HSP) and Good Clinical Practice (GCP), as well as current professional practice licenses and CVs ▪ Create and maintain electronic regulatory study binders ▪ Work with study teams on developing the study-specific consent procedures and S.O. Ps ▪ Review of Informed Consent documents ▪ Maintain the tracking system for submissions to ethical and regulatory bodies. ▪ Liaison with the study PIs and study coordinators, take the lead on communications and submissions to ethical, regulatory bodies and Sponsors
A degree in Nursing or Bioethics or other health related field. ▪ At least 2 years' relevant experience in the health research sector. ▪ Knowledge of MS packages required. ▪ Maintain high level of personal integrity and reliability. Be willing to work extra/overtime hours as needed according to departmental workload. ▪ Knowledge of national and international research regulations/guidelines ▪ Knowledge of bioethics is desirable ▪ An individual with good communication and interpersonal skills, ability to pay attention to detail, multi –task and an excellent team player
