ASSIST RESEARCH PRACTICE MANAGER
School of Medicine:
Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.
Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
Assist Research Practice Manager/RADONC Clinical Trials
Clinical research or oncology experience a plus
Responsible to the Department Chair and works closely with the Director of Clinical for the day-to-day operations of the CRU cluster or delegated CRU responsibilities associated with the Site-Based Research group's participation in clinical research studies as an investigative site. Ensure that CRCs and designated research personnel are performing study activities in accordance with Good Clinical Practice (GCP), Duke policy and regulatory requirements using Standard Operating Procedures (SOPs) and periodic monitoring.
Study Conduct: 10%
Screen participants for all studies independently. Maintain subject level documentation for all studies independently Schedule participants and conduct visits for all studies independently. Train others to conduct and document visits and protocol-specific testing/interviews. Assist with development and follow procedures and documentation of study payment in timely fashion. Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks. Assist with management of IP. Employ the required system for handling, dispensing and documentation of IP for sponsored protocols. May be responsible for determining the best methods for handling IP for Investigator-initiated protocols, or coordinating with investigational pharmacies as necessary. Maintain appropriate documentation. Track IP compliance at the protocol-and subject level. Independently maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc. Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs. Evaluate processes to identify issues related to recruitment and retention rates. Conduct and document consent for participants in a variety of studies independently Assist with addressing and correcting findings from study monitoring and study audit visits. Collect, prepare or process adverse event information independently Complete and submit AE Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) independently. Develop DUHS IRB documents such as consent forms, protocols, and continuing reviews independently and train other staff in these tasks.
Communicate to research participants, both orally and written, the difference between clinical activities and research activities in all study documents and research participant communications. Train junior staff in the ethical conduct of research, and provide guidance in strategies used to maintain safety. Assist with the development of Conflict of Interest (COI)/Data Safety Monitoring Plans (DSMPs)/Research Data Security Plans (RDSPs). Assist with the coordination of efforts of external
monitoring boards. Articulate, to study staff and research participants, the pathophysiology or reasoning for an individual protocol's inclusion and exclusion criteria.
Map protocol data flow. Predict areas of vulnerability for a protocol's data flow plan. Determine areas where data provenance may be compromised. Use EDC systems and enter data accurately and train others in these tasks. Detect issues related to data capture, collection or management and suggest solutions. Use required processes, policies, and systems to ensure data security and provenance. Recognize and report vulnerabilities related to security of physical and electronic data. Independently investigate incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data. Run summaries and reports on existing data Assist with development of and follow SOPs for data quality assurance. Assemble the necessary parties to ensure that all agreements are in place (DUA, DTA, etc.)
Identify various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of study aims. Assist with development of research proposals or protocols.
Actively network and encourage leadership for staff within a small work group. Take part in a committee, task force, or ad hoc group. Encourage career development by actively seeking out continuing education opportunities for self and study team members. Participate in scientific presentations and publications. Assign, review, and train others in various work responsibilities. Serve as a mentor to junior staff, including others with my title. Employ escalation and performance plans as needed. Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical research. Maintain training requirements and develop solutions to proactively ensure study team members' compliance with training requirements. Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research. Make recommendations to investigative team.
Study and Site Management:
Collect information to determine appropriate feasibility, recruitment and retention strategies. Ensure participant care expenses have appropriate financial routing in a timely manner. Monitor financial study milestones and report appropriately. Coordinate with financial teams, PRMO, etc. and participate in budget development as appropriate. Assist with study budgets. Maintain study's compliance with institutional requirements and other policies (e.g., NIH Public Access policy, ct.gov, Research Data Security Plans, Social Media policy, etc.). Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties. Take part in site initiation/closeout visits as directed.
Assist with the development of protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms. Take part in or lead closeout and document storage activities
Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively. Participate in study team meetings. Respond to routine questions related to study protocol and refer more complex questions to others as appropriate. Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution.
Manage Durham VA clinical research portfolio and support research activities at satellite facilities.
Oncology experience, good communication skills and has experience managing personnel and familiar with Duke's policies.
Work requires completion of a Bachelor's degree. ACRP or SOCRA certification preferred.
Work requires a minimum of six years of related experience, with at least four 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.
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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.