Research Practice Manager
The research position for which you are applying is not specific to a clinical research area. Instead, your resume may be shared across the Duke School of Medicine in order to increase the visibility and likelihood of matching eligible candidates with open positions specific to the job title for which you have applied.
Responsible to the CRU Director for the day-to-day operations of the CRU related to study conduct. Ensure that CRCs and designated research personnel are performing activities in accordance with good clinical practice, CRU standards, Institutional Policy and regulatory requirements using Standard Operating Procedures (SOPs) and periodic monitoring.
- 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 CRSO as needed.
- Manage the day-to-day operations of the CRU related to study conduct including IRB submissions and renewals; protocol initiation; participant recruitment, screening, consent and enrollment; safety reporting; and study close-out, record retention and audit ready files stored.
- 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 regarding SOPs, and that all activities are conducted in accordance with SOPs.
- In centralized models where CRCs report directly to the RPM, recruit and hire CRCs with faculty input. Perform annual performance evaluations of CRCs in CRU's where CRCs report directly to the RPM. Coordinate and assign CRCs and other research staff to specific studies and research related activities. Some CRUs may not be structured at this point to allow re-assignment of CRCs based on volume of activity. This role is advisory to the PI and the CRU director.
- Because of the size of some SBRs, the central management model may not be practical in terms of numerous CRCs reporting to a single RPM. These SBRs may utilize a cluster management model approach where there is a "cluster lead" CRC to who the study conduct and regulatory compliance duties of all cluster CRCs report. The cluster lead is then accountable to the RPM.
- Coordinate orientation and ongoing training for CRCs and other research staff. Ensure that current training records and required certifications are maintained and that all CRCs identified by the e-IRB system as responsible for a given protocol are qualified to serve in that role. Central administration will provide a report which identifies key personnel on each study on a quarterly or other acceptable basis.
- Serve as an expert resource to PIs, CRCs ,other research staff and outside agencies with regard to study-specific protocol requirements and problem-solving related to clinical, logistical, financial and regulatory issues.
- Assist PIs, CRCs and research staff in the development of subject recruitment strategies, identification of barriers to enrollment, and implementation of appropriate interventions.
- CRC activities supervised by the RPM include the following: Submit IRB protocols, amendments and renewals; Initiate studies; Recruit, screen, consent, enroll and follow-up with research participants; collect data and resolve queries; Supervise monitoring visits; Perform safety reporting; Ensure study drug compliance & drug accountability; Communicate research issues within and outside the department; Close out studies and ensure retention of records per Duke and sponsor policy; Ensure that research activities are performed in accordance with Good Clinical Practice standards, Duke policies and procedures, and applicable regulatory requirements; Enter subjects into eResearch in a timely and accurate manner; Monitor the progress of start-up timelines for new studies, including IRB approval, contract negotiations, budget & payment terms negotiation and development of the charge assignment grid, while providing regular updates to the CRU Director; Monitor the progress of ongoing studies including enrollment, data collection, and close-out, while providing regular updates to the CRU Director and other related research activities as determined by the RPM in day to day operations.
- Conduct CRU QA audits.
- Work with the CRU Financial Practice Manager (FPM) to: Evaluate the feasibility of new studies including staffing requirements, clinical and logistical considerations, and competing studies; provide input into financial feasibility of each new study by providing study plan details to FPM for the development of an internal cost summary; review and evaluate the charge assignment grid based on the schedule of events and protocol; provide training and consultative advice to PIs and CRCs in the negotiation of study budgets & payment terms with sponsors; regularly review study finances prepared by FPM; and facilitate efforts with FPM to address budget-related issues with the CRU Director, PIs, and CRCs as appropriate
- Perform other related duties incidental to the work described herein.
- 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.
Requisition Number: 100005611
Duke Entity: MEDICAL CENTER
Job Code: 1029 RESEARCH PRACTICE MANAGER
Job Family Level: 69
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 five years in a research setting. ACRP or SOCRA preferred. OR RN or Bachelor's degree and 6 years of related experience, with at least five years in a research setting. ACRP or SOCRA preferred. OR Master's degree and 4 years of related experience, with at least three years in a research setting. ACRP or SOCRA preferred.
No experience is required beyond what is specified above.
Auto req: ID106712BR