Manager, Clinical Research Quality Control
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The Manager, Clinical Research Quality Control is responsible for the ongoing development and execution of a comprehensive real time Quality Control Program for all Oncology Clinical Trial Research conducted by HMH Clinical Cancer Research Department. The Mgr, Clin Rsrch Quality Cntrl ensures and tracks department and clinical trial compliance with Local, State, and Federal Regulations, Good Clinical Practice (GCP), and Institutional policies. He/she serves as a clinical trial compliance liaison between Investigators, research team members, the Institutional Review Board (IRB), and third party vendors. Coordinates, troubleshoots, and seeks improvement opportunities throughout the oncology clinical research program in collaboration with Oncology Leadership, the IRB, Research Integrity Office, and external sponsors and regulatory agencies.
A day in the life of a Manager, Clinical Research Quality Control at Hackensack Meridian can be described as follows:
1. Oversees and conducts real time, random ongoing quality control reviews across all components of the oncology research enterprise and summarizes findings in detailed reports and executive summaries.
2. Ensures that all clinical research staff and all research studies are conducted in full compliance with written protocols, SOPs, HUMC Policy, current Good Clinical Practice, IRB policies, Local, State, And Federal regulations, and Joint Commission rules.
3. Participates in the hiring, training, management, and terminating of Quality Control support staff.
4. Utilizes clinical judgment and critical thinking to review the completeness of patient assessments, interpret the findings of test results, evaluate the accuracy of medication administration, and determine if patient care is provided according to protocol requirements and institutional policies.
5. Uses knowledge of oncology practice and appropriate resources to determine which tests and evaluations are consistent with standard of care and which are research related.
6. Reviews records to ensure research related evaluations and tests are conducted in accordance with regulatory requirements.
7. Assesses relevant safety information including toxicity assessments and safety reports to evaluate patient safety issues related to protocol care.
8. Utilizes knowledge of research regulations to identify any violations of human subject's protections requirements.
9. Notifies investigators, institutional review committees, and relevant stakeholders of any safety or human subject's protections related findings.
10. Reviews and facilitates research activities that involve complex issues and short time frames as required.
11. Travels to collaborating sites to facilitate and review research activities as required.
12. Communicates relevant information and findings both verbally and through formal written reports. Presents findings to individuals, groups, and committees as required.
13. Serves as a resource in the interpretation of complex clinical research issues. Identifies quality improvement opportunities and participates in the development of quality related initiatives.
14. Participates in the development of risk assessment tools and the development of assignments.
15. Assists with the review of standard operating procedures.
16. Oversees and engages in the regulatory review, preparation, and submission of clinical study documentation (e.g. investigator brochure, Investigational Device Exemption (IDE), Investigational New Drug (IND), treatment, and compassionate/emergent use, etc.) as required.
17. Oversees the CTSU application for Clinical Cancer Research Staff and Investigators.
18. Leads team meetings and attendance at leadership meetings and conference/in-services as required.
19. Provides timely follow-up, issue resolution, update reports, and problem escalation as necessary.
20. Develops, implements, and tracks metric reports to evaluate regulatory compliance and performance according to department needs.
21. Participates in the orientation and training of new clinical research staff regarding regulatory and protocol compliance responsibilities.
22. Assists in policy, procedure, and workflow development processes.
23. Meets with FDA auditors and sponsor representatives as required.
24. Reviews correspondences from sponsors and regulatory authorities (monitoring follow up letters, quality assurance); to ensure all outstanding items are resolved.
25. Works closely with staff and department to ensure corrective action plans for audit deficiencies are resolved.
26. Works on special projects for Clinical Cancer Research Department quality assurance, regulatory affairs and education sections, including submission of standard operating procedures (SOPs).
27. Attends educational offerings and conferences to stay current on best practices and maintains overall awareness in the field of clinical research, as well as assigned areas.
28. Performs other work-related duties as assigned.
29. Adheres to HUMC and Departmental organizational and managerial competency requirements.
30. Reports directly to Director Clinical Cancer Research.
Education, Knowledge, Skills and Abilities Required:
1. Bachelor's degree in the sciences.
2. Minimum of 3 years of quality control/assurance work experience in healthcare setting.
3. Minimum of 3 years of oncology clinical trial conduct work experience in healthcare setting. 4. Minimum of 3 years of supervisory experience.
5. Excellent computer and analytical skills (Excel and Word).
Education, Knowledge, Skills and Abilities Preferred:
1. Master's degree in the sciences.
2. Minimum of 5 years of supervisory experience.
Licenses and Certifications Required:
1. Society of Clinical Research Associates Certification or Association for Clinical Research Professionals Certification.
If you feel that the above description speaks directly to your strengths and capabilities, then please apply today!
As a courtesy to assist you in your job search, we would like to send your resume to other areas of our Hackensack Meridian Health network who may have current openings that fit your skills and experience.