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Research Practice Manager - Psychiatry Chair's Office

Work Arrangement: 
Requisition Number:  212639
Regular or Temporary:  Regular
Location: 

Durham, NC, US, 27710

Personnel Area:  MEDICAL CENTER
Date:  Nov 1, 2022
School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Occupational Summary

Report to the Clinical Research Unit (CRU) Director and Research Administration Director.  Responsible for the daily CRU operations and staff management related to clinical research. Ensure that research faculty and staff are trained are performing activities in accordance with good clinical practice, CRU standards, Institutional Policy and regulatory requirements using Standard Operating Procedures (SOPs) and periodic monitoring. Draft and implement strategic initiatives aligned with the department goals for the research mission. Manage the clinical research facility and ensure ongoing and new research can be accommodated and implemented in the facility.

 

Work Performed

Accountable for performing activities in accordance with all institutional standards for study conduct, and more specifically those relating to clinical research, providing information to the central offices as needed.

 

Manage the daily operations of the CRU related to study conduct and specific research support tasks that may in include IRB submissions renewals; protocol initiation; study start-up, participant recruitment, screening, consent and enrollment; safety reporting; and study close-out, record retention and audit files. Monitor the status of timelines and key milestones for clinical research studies conducted within the CRU including contract execution, IRB approval, enrollment, etc. 

Participate in audits conducted of CRU studies by both internal and external authorities. Review and respond to audit reports, and develop and implement corrective action in a timely manner when problems are identified.   

Ensure that the CRU has up-to-date standard operating procedures, that staff are knowledgeable and conduct research according to SOPs. Continuously identify methods to improve CRU and institutional procedures and policies.  Communicate effectively across the CRU regarding new policies, regulatory updates, and departmental or institutional SOP changes.

Recruit and hire Workforce Engagement and Resilience (WE-R) staff who directly report to the CRU core team. Perform annual performance evaluations of Assistant Research Practice Managers (ARPMs) and other staff reporting to the RPM. Coordinate and assign WE-R research staff to specific studies and research related activities.

 

Collaborate with Duke Office of Clinical Research (DOCR) and other School of Medicine (SOM) resources to conduct recruitment, onboarding, training, and professional guidance for clinical research professionals.  Responsible for appropriately requesting and managing clinical research system access for staff.  Ensure that current training records and required certifications are maintained and that all WE-R staff identified by the e-IRB system as responsible for a given protocol are qualified to serve in that role.

 

Serve as an expert resource to PIs and research staff and outside agencies with regard WE-R staff recruitment, performance management, study-specific protocol requirements and problem-solving related to clinical, logistical, financial and regulatory issues. Assist PIs and research staff in the development of subject recruitment strategies, identification of barriers to enrollment, and implementation of appropriate interventions.

 

WE-R staff activities include the following: compliance with all Duke, meeting sponsor and federal regulatory requirements; applied Good Clinical Practice standards; IRB protocols submission, IRB amendments and renewals; study start-up; recruitment, screening, consent, enrollment and follow-up with research participants; data collection and fielding research questions; supervision of  monitored visits; safety reporting; study drug compliance & drug accountability; communication of research issues within and outside the department; study closeout and record retention; timely and accurate data entries; monitoring the progress of start-up timelines for new studies, budget and contract review.

 

Collaborate with the Financial Practice Manager (FPM) to evaluate the feasibility of new studies and proposal budgets.  Review industry proposal lists with FPM weekly to ensure they are acceptable studies aligned with departmental goals and risk levels.

 

Assist Vice Chair for Research and CRU Director with implementation of initiatives for research mission. Develop programs to support junior faculty in launching clinical research. Manage a team of trained central staff to assist with ad hock research projects. Assist with identifying and managing faculty and staff relations issues and help leadership with mitigating various risks to the department’s clinical research program.

 

Oversee compliance with institutional requirements and serve as an expert resource at Duke pertaining to: developing and submitting documentation and information for IRB review, documentation needed for regulatory and safety reporting to sponsors and other agencies, identification and documentation of adverse events, consent process and documenting, quality data collection and capture, data flow plans, data security and provenance, and data quality assurance.

 

Responsible for the implementation, adoption, and monitoring of new research technologies or systems (e.g. Oncore, Maestro Care, etc.) and data capture requirements across the CRU.

Keep current with research and institutional updates and oversee necessary implementation among CRU staff members.

Evaluate and implement professional development and/or training programs offered through DOCR (e.g., Research Professionals Network (RPN), Research Wednesdays) to encourage staff retention, continuous improvement, and development.

Participate or lead institutional initiatives or committees and/or serve in a leadership capacity in professional organizations.

Use expertise and acumen to influence change at the CRU level. Demonstrate resilience, leadership, and actively facilitate change for CRU.

Create a team environment with a culture that fosters communication, respect, and inclusion.

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

 

Minimum Qualifications

Education

Work requires completion of a Bachelor's degree.

 

Experience

Work requires a minimum of eight years of related experience, with at least five years in a research setting. A Master's degree may substitute for two years of related experience.

 

 

Duke 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 essentialjob 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.

 


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