RESEARCH PRACTICE MANAGER ONCOLOGY CLINICAL RESEARCH HYBRID
Company: Duke Clinical Research Institute
Posted on: September 19, 2023
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.
Research Practice Manager [RPM], Oncology Clinical Research Unit
Responsible for the oversight of research and day-to-day operations
including finances and personnel management for the Brain Tumor
Center Clinical Research Program of the Duke Cancer Institute
[DCI]. Collaborate closely with DCI Leadership, Finance and Human
Resources, Duke Office of Clinical Research [DOCR], School of
Medicine [SOM], Principal Investigators [PIs] and departments
throughout the institution to carry out these responsibilities
Research Operations - 40% of effort
Oversee study conduct including study initiation, IRB submissions
and renewals, protocol initiation, participant recruitment,
screening, consent and enrollment, data collection, safety
reporting, study monitoring and audits, study closeout, and record
retention and storage. Assist with the development of participant
recruitment strategies, identification of barriers to enrollment,
and implementation of appropriate interventions.
Monitor the status of timelines and milestones for research studies
to ensure timeliness, performance in accordance with all
institutional standards, and compliance with Good Clinical Practice
standards, Duke Policies and procedures, SOPs, and applicable
regulatory requirements. Provide updates and reports to leadership
Conduct quality assurance audits. Oversee and participate in
internal and external audits. Review and implement audit reports;
develop and implement corrective actions plans in response to
Oversee compliance with institutional requirements pertaining to
quality data collection and capture, data flow plans, data security
and provenance, and data quality assurance. Connect study teams
with stakeholders (e.g., statisticians) and institutional resources
(e.g., ISO, IRB) to ensure data quality. Ensure Quality Assurance
processes are in place and followed.
Responsible for the implementation, adoption, and monitoring of new
research technologies or systems and data capture requirements
(e.g. Oncore, Maestro Care, eReg, Advarra EDC etc.).
Financial - 20% of effort
Collaborate on writing and implementing contracts and
Collaborate and work closely with the DCI Finance Team and assigned
research programs on the feasibility of new studies including
staffing requirements, clinical and logistical considerations,
drafting budgets, and budget negotiation and payment terms,
maximizing revenue, effort reporting and closing out studies.
Review financial reports to identify and implement solutions to
budget-related issues. Bring in DCI leadership, PIs, research staff
and others for discussions and solutions.
Manage and approve monthly staff effort in collaboration with the
Management - 25% of effort
Responsible for requesting and managing clinical research system
access for staff.
Continuously identify methods to improve CRU and institutional
procedures and policies. Base decisions on data analysis collected
via clinical research management systems.
Develop strategies to ensure implementation of institutional SOPs,
policies, and initiatives.
Oversee the writing, implementation and maintenance of standard
operating procedures [SOP] within the DCI CRU. Ensure staff are
trained and knowledgeable in SOPs.
Oversee orientation and ongoing training for staff on your teams.
Oversee the documentation of staff's requited training and
certifications. Ensure staff identified by the e-IRB system as
responsible for a given protocol qualify for the role and maintain
Conduct and lead meetings for leadership, teams, and staff to
ensure good communication, including goals. Effectively communicate
new policies, regulatory updates, and institutional SOP
Leadership - 15 % of effort
Manage the day-to-day assignments, work schedule, work location,
time including time-off, complete yearly evaluations, actively
engage in performance management, career development, hire,
terminate, and be a mentor and coach for direct reports.
Embody the DCI's core value "Cancer Care as It Should Be" to
deliver the highest quality care in our patient-centric clinical
research, as a leader of research staff and for all of the DCI.
Create a culture that fosters open communication, motivates staff,
and encourages creativity.
Oversee the fair and consistent application of human resource
policies, and promptly address problems to manage your teams
effectively. Collaborate closely with DCI Human Resources and your
manager on personnel issues; implementing policies, personnel file
documentation and compliance. Ensure your managers carry these out
For direct reports manage their day-to-day assignments, work
schedule, work location, approve time off requests, conduct yearly
evaluations and goal setting, and actively engage in performance
management including corrective action.
Serve as an expert resource on study-specific protocol requirements
and problem solving for clinical, logistical, financial and
Implement professional development and training programs to
encourage staff retention, continuous improvement, and development
(e.g. DOCR: Research Professionals Network (RPN), Research
Assist in the development and implementation of solutions at the
institutional level to improve the research process. Use expertise
and acumen to influence change within the DCI. Demonstrate
resilience, leadership, and actively facilitate change.
Know and follow policies, standard operating procedures [SOPs],
regulations and protocol requirements that govern clinical
research. Maintain Duke and project specific training and
Basic Life Saving [BLS] certification from the American Heart
Association or Duke approved equivalent course is a requirement of
Other work as assigned.
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.
Qualifications Required At This Level
Link to the required education, training, experience and skills
required for a 1029 Research Practice Manager classification:
Work requires completion of a Bachelor's degree. ACRP or SOCRA
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
Nearest Major Market: Durham
Nearest Secondary Market: Raleigh
Keywords: Duke Clinical Research Institute, Durham , RESEARCH PRACTICE MANAGER ONCOLOGY CLINICAL RESEARCH HYBRID, Executive , Durham, North Carolina
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