Assistant Research Practice Manager
The Department of Medicine (DOM) ARPM – Quality Assurance (QA) Manager will develop and coordinate the overall Quality Management and Quality Assurance process for the Department of Medicine CRU. This position will develop quality processes, provide training and oversight across multiple divisions in quality processes, and act as liaison with other entities at Duke with oversight responsibility for research quality. This individual will act as expert resource to the entire CRU on best practices in study development, conduct, and documentation.
Develop, implement and oversee quality assurance and regulatory compliance within in the DOM CRU, ensuring compliance with all institutional policies. Interface with all Duke Entities that provide oversight and guidance on research quality.
Independently perform CQMP audits that are accurate, timely, and complete while also ensuring that all deficiencies are followed to resolution in a thorough and timely manner.
Develop and implement standard operating procedures for monitoring and auditing of clinical trials. Ensure trials are consistent with proposals approved by the Institutional Review Board, and in compliance with applicable federal and state laws, statutes and regulations.
Ensure that CRU personnel are knowledgeable regarding SOPs or Best Practices, and that all activities are conducted in accordance with SOPs. Provide CRU-wide or study team training as needed.
Identify and report general compliance issues that may arise through the work process; write and revise standard operating procedures.
Serve as a resource for divisions during audits conducted by the Duke Office of Audit, Risk and Compliance (OARC), sponsors, and regulatory authorities. Be available to assist in the review of and response to audit reports. Develop and implement corrective action plans in a timely manner when problems in research practice are identified.
In conjunction with the CRU Leadership team, lead or participate in regular meetings with study coordinators and other research staff. Ensure that staff are kept abreast of CRU, departmental and institutional activities, goals, and policies and procedures.
In conjunction with the CRU Leadership team, lead or participate in the orientation of new study staff ensuring that current training records and required certifications are maintained.
Serve as an expert resource to PIs, study coordinators and other research staff with regard to study-specific protocol requirements and problem solving related to clinical, logistical, financial and regulatory issues.
Duke Entity MEDICAL CENTER
Job Family Level 68
Full Time / Part Time FULL TIME
Regular / Temporary Regular
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions:
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department
Allied Health degree or Associates degree in Clinical Trials Research and 8 years of related experience, with at least four years in a research setting. ACRP or SOCRA preferred. OR RN or Bachelor's degree and 6 years of related experience, with at least four years in a research setting. ACRP or SOCRA preferred. OR Master's degree and 4 years of related experience, with at least two years in a research setting. ACRP or SOCRA preferred. Experience
No experience is required beyond what is specified above.
The ideal candidate will have experience in all aspects of human subject research including program development, training and education, matters related to compliance, resource management, communication and dissemination, and overall program development and implementation across a large and diverse department.
Collaboration, communication and leadership skills will be required.
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job related tasks other than those specifically presented in this description.