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Compliance Officer

Full Time
Michigan
Posted 4 weeks ago

Coordinate, implement and analyze quality processes that ensure clinical research compliance with regulatory and Quality Assurance standards. Along with ensuring compliance amongst research team members.

Compliance Officer role and responsibilities:

  • Supports the development of programs and plans to support quality improvement.
  • Demonstrates quality improvement process-management skills.
  • Demonstrate proficiency in identifying, defining, and analyzing goals.
  • Analyze compliance data and prepare audit reports and summaries of findings.
  • Oversee training for all protocols as well as requirements for regulations.
  • Ensure that the safety, welfare and dignity of subjects are not compromised.
  • Ensure that the office, scientific and medical standards provided are met.

Quality Assurance:

  • Coordinate, implement and analyze quality processes that ensure clinical research compliance with regulatory and Quality Assurance standards.
  • Organize and perform random, for-cause, and regulatory committee-requested audits of clinical research studies, as appropriate, to ensure compliance with applicable regulations and guidelines.
  • Support the development of clinical research programs and plans to support quality improvement.
  • Develop and implement clinical research quality improvement projects and initiatives and serve as a member of project teams.
  • Serve as a resource for clinical research policy and standards interpretation and ensure utilization in operations.
  • Maintain a current knowledge of federal and state laws, as well as regulations and guidelines governing human subjects research.
  • Maintain company HIPAA manuals and ensure all team members have reviewed and signed off on it.
  • Ensure each staff member has a current Good Clinical Practices (GCP), HIPAA and Human Subject Protection (HSP) certificates.
  • Ensure the subject charts have been QA’d and are up-to-date and audit ready.
  • Ensure monitoring visits and sponsor/FDA audits are completed successfully.
  • Ensure that all work is carried out in strict adherence with relevant protocols, SOP’s, and in compliance with ICH/GCP guidelines. Ensure that managers/research staff is trained and compliant with SOP’s and Skills checks. Ensure that all training files are up to date and complete in accordance with SOPs and ICH/GCP.

Process Improvement:

  • Participate in clinical research process improvement projects and tasks including providing expertise and guidance during organizational meetings.
  • Develop and update clinical research documentation that can be communicated efficiently to all levels within the project.
  • Coordinate timely communication of quality management initiatives.
  • Summarize data in a format that will facilitate identification and prioritization of improvement initiatives.
  • Participate in continuous quality improvement analysis to ensure efficiency, compliance, and productivity to meet the highest clinical research standards possible. This includes training with staff development for on-site and off-site personnel, as required.
  • Support the team and investigators in overall conduct of trials.

Communication:

  • Communicate with internal and external customers.
  • Meet with leadership and staff to elicit training, education and compliance requirements.
  • Develop audience-appropriate presentations regarding clinical research quality and compliance issues and implementations.
  • Perform routine compliance reviews related to the clinical trials and IRB activities.
  • Investigate allegations and findings of non-compliance. Report potential serious or continuing non-compliance with applicable regulations or institutional policies and other leaders as appropriate. Provide Principal Investigators with quality improvement recommendations to ensure that research is conducted in compliance with regulations and approved protocols.
  • Prepare written reports detailing observations, regulatory risks, recommendations, and any other actions necessary to bring the research or IRB activity into compliance.
  • Assist investigators and the institution in preparations for external audits and inspections by sponsors, grantors, accrediting bodies, and regulatory authorities. Provide education on expectations and how best to prepare and organize materials and interact with the auditors or inspectors. Interview personnel and review records in advance to identify possible areas of concern so that the issues can be proactively addressed.
  • Provide support and guidance to exit interviews. Assist in the development of corrective actions and written responses as warranted.
  • Demonstrate analytical skills to gather, interpret, organize and present compliance-related data and work collaboratively with interdisciplinary teams of external and internal individuals.

Compliance Program:

  • Organize and implement the company’s Compliance Program.
  • Prepare the Compliance program agenda for 2 months out in advance to ensure we have proper coverage in case of any cancellations.
  • Schedule Compliance Trainings bi-weekly on Wednesdays from 12pm-1pm EST and email the reminder 3 days before the meeting and again the morning of the training. Any training slides or documents for the presentation should be sent out with the invitation as well.
  • Attendance should be maintained and all attendees shall sign a sign in sheet to confirm their attendance.
  • Following each training session, a quiz on that topic should be generated and sent out to all attendees.
  • Certificates are to be provided after someone successfully passes the quiz.
  • The recorded trainings need to be maintained on the Company’s Training Portal.
  • Oversee training for all protocols as well as requirements for regulations.

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