Regulatory Compliance Associate ; AES

The Regulatory Compliance Associate is responsible for all aspects of regulatory compliance and documentation, quality control, as well as organizational training related to GCP and SOP compliance. Maintains communication with the IRB and reviews on-site files, folders, binders, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provides remedial training and/or initiatescorrective action as required. Ensures that essential documents are organized, up to date and in compliance with ICH/GCP guidelines and federal regulations. Assists Site Leads and other staff with regulatory compliance and documentation, focused reviews, and quality improvement activities.

Essential Job Duties:

1. Maintain the regulatory documents at the site.

2. Follows the organization’s SOPs and provides guidance with staff comprehension and compliance with the SOPs.

3. Assist with and coordinate development of clinical trial support documents.

4. Ensures maintenance of regulatory documents/binders in an organized and systematic fashion to facilitate the monitoring and auditing of research studies.

5. Ensures IND safety reports are distributed to investigators and research team for review.

6. Ensures that all required regulatory documents are updated in the site’s regulatory binder throughout the life of the study.

7. Assembles, reproduces and archives (hard and electronic copies) technical documents, as appropriate for the document type.

8. Report on the status of clinical trials.

9. Facilitate communication with the IRB and/or Sponsors.

10. Ensure safety of all patients treated with investigational products and assist with all regulatory filings in this regard.

11. Represents Clinical Research Advantage/Radiant Research, Inc. to sponsor

representatives and regulatory agencies.

12. Performs quality reviews of data generated from clinical trials.

13. Collaborates with the research team to facilitate overall protocol operations.

14. Keep documents organized and ready for audit and ready for regulatory filings when required.

15. Identifies problems and issues and takes corrective action and/or escalates appropriately.

16. Track sponsor and IRB approvals and renewals.

17. Generates and reviews reports of regulatory data using appropriate systems.

18. Assist in training programs as requested.

19. Uses appropriate IT and software tools to ensure the correct format and presentation of documents.

20. Ensures all assigned tasks are conducted in accordance with federal regulations and ICH/GCP.

21. Achieves appropriate quality standards in all documentation within the timelines dictated by project plans and company expectations.

22. Prioritizes personal workload in line with agreed project plans.

23. Supports and assists with team/office activities/duties and assume responsibility for activities, as necessary, to fulfill company needs.

24. Participates in business development activities.The Regulatory Compliance Associate is responsible for all aspects of regulatory compliance and documentation, quality control, as well as organizational training related to GCP and SOP compliance. Maintains communication with the IRB and reviews on-site files, folders, binders, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provides remedial training and/or initiatescorrective action as required. Ensures that essential documents are organized, up to date and in compliance with ICH/GCP guidelines and federal regulations. Assists Site Leads and other staff with regulatory compliance and documentation, focused reviews, and quality improvement activities.

Essential Job Duties:

1. Maintain the regulatory documents at the site.

2. Follows the organization’s SOPs and provides guidance with staff comprehension and compliance with the SOPs.

3. Assist with and coordinate development of clinical trial support documents.

4. Ensures maintenance of regulatory documents/binders in an organized and systematic fashion to facilitate the monitoring and auditing of research studies.

5. Ensures IND safety reports are distributed to investigators and research team for review.

6. Ensures that all required regulatory documents are updated in the site’s regulatory binder throughout the life of the study.

7. Assembles, reproduces and archives (hard and electronic copies) technical documents, as appropriate for the document type.

8. Report on the status of clinical trials.

9. Facilitate communication with the IRB and/or Sponsors.

10. Ensure safety of all patients treated with investigational products and assist with all regulatory filings in this regard.

11. Represents Clinical Research Advantage/Radiant Research, Inc. to sponsor

representatives and regulatory agencies.

12. Performs quality reviews of data generated from clinical trials.

13. Collaborates with the research team to facilitate overall protocol operations.

14. Keep documents organized and ready for audit and ready for regulatory filings when required.

15. Identifies problems and issues and takes corrective action and/or escalates appropriately.

16. Track sponsor and IRB approvals and renewals.

17. Generates and reviews reports of regulatory data using appropriate systems.

18. Assist in training programs as requested.

19. Uses appropriate IT and software tools to ensure the correct format and presentation of documents.

20. Ensures all assigned tasks are conducted in accordance with federal regulations and ICH/GCP.

21. Achieves appropriate quality standards in all documentation within the timelines dictated by project plans and company expectations.

22. Prioritizes personal workload in line with agreed project plans.

23. Supports and assists with team/office activities/duties and assume responsibility for activities, as necessary, to fulfill company needs.

24. Participates in business development activities.Qualifications: A Bachelor’s degree and a minimum of 2 years experience in Clinical Research, or an equivalent combination of education and experience is required. Knowledge of GCP/ICH regulatory guidelines and clinical trial processes is required. Document management and/or Regulatory experience a plus.

Required Skills:Strong proficiency in Microsoft Office programs (Outlook, Word) and Web applications;Exceptional organizational skills, attention to detail and follow through;Ability to type proficiently (35 wpm);Excellent verbal and written communication skills;Well-developed interpersonal skills and the ability to work well independently as well as with co-workers, peers, supervisors and external customers;Ability to effectively and efficiently handle multiple tasks simultaneously with precision and adapt to changes in responsibilities and workloads;Must be professional, possess a high degree of urgency and self-motivation, and have a strong work ethic;Qualifications: A Bachelor’s degree and a minimum of 2 years experience in Clinical Research, or an equivalent combination of education and experience is required. Knowledge of GCP/ICH regulatory guidelines and clinical trial processes is required. Document management and/or Regulatory experience a plus.

Required Skills:Strong proficiency in Microsoft Office programs (Outlook, Word) and Web applications;Exceptional organizational skills, attention to detail and follow through;Ability to type proficiently (35 wpm);Excellent verbal and written communication skills;Well-developed interpersonal skills and the ability to work well independently as well as with co-workers, peers, supervisors and external customers;Ability to effectively and efficiently handle multiple tasks simultaneously with precision and adapt to changes in responsibilities and workloads;Must be professional, possess a high degree of urgency and self-motivation, and have a strong work ethic;