RESEARCH PRACTICE MANAGER
RESEARCH PRACTICE MANAGER
Medicine - General
Responsible to the Associate Director, Medicine CRU 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 Duke Office of Clinical Research (DOCR) and others 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.
Proactively identify areas of risk to research subjects and develop plans to mitigate these risks.
Monitor and report on the status of timelines and key milestones for clinical research studies conducted within the CRU including contract execution, IRB approval, enrollment, closure, 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, developing new SOPs as necessary. Ensure that staff are knowledgeable regarding SOPs, and that all activities are conducted in accordance with SOPs.
Medicine CRU utilizes a management model where there is a cluster lead CRC or assistant RPM (ARPM) to whom the study conduct and regulatory compliance duties of all cluster CRCs report. The cluster leads are directly accountable to the RPM.
Involved in recruiting and hiring CRCs with faculty and leadership input. Perform annual performance evaluations of direct reports. Provide evaluation input for research professional staff who do not report directly to 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 Medical Director.
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 eIRB 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.
Lead efforts to ensure effective team dynamics and teamwork to maximize productivity, ensure faculty and staff satisfaction, and minimize staff turnover while maintaining high quality standards. Provide development opportunities for assigned staff including coaching, mentoring and performance management.
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 and 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 MaestroCare and/or other electronic health systems 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 and Vice-Chair of Research; Monitor the progress of ongoing studies including enrollment, data collection, and close-out, while providing regular updates to the CRU Medical Director and other related research activities as determined by the RPM in day-to-day operations.
Oversee the Medicine CRU regulatory team. Conduct QA audits on protocols submitted through the Medicine CRU.
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 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 Associate Director, 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.
1029 RESEARCH PRACTICE MANAGER
Job Family Level
Full Time / Part Time
Regular / Temporary
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender identity, national origin, race, religion, sexual orientation, or veteran status. ******************************************************* 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.
Previous supervisory experience is strongly preferred. Prefer experience managing multiple levels and numbers of employees.
Strong interpersonal skills and ability to build credibility and positive relationships with Principal Investigators, CRCs and other research staff.
Strong knowledge of research operations, conduct (including GCP) and applicable regulatory requirements.
Demonstrated ability to manage a heavy workload by prioritizing appropriately.
Strongly prefer national certification as a clinical research professional.
Auto req ID
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
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.