ASSIST RESEARCH PRACTICE MANAGER
ASSIST RESEARCH PRACTICE MANAGER
DCI OFFICE OF RESEARCH SUPPORT
Occupational Summary . This is a 100% sponsored funded position.
Responsible to the Oncology Clinical Research Unit (OncCRU) Research Practice Manager (RPM) for the day-to-day operations of the OncCRU cluster or delegated OncCRU responsibilities associated with the Clinical Research group's participation in clinical research studies as an investigative site. Ensure the Clinical Research Coordinators (CRC) & designated research personnel are performing study activities in accordance with Good Clinical Practice (GCP), Duke Policy & Regulatory requirements using Standard Operating Procedures (SOPs), OncCRU policy & periodic monitoring.
Maintain a close, collaborative working relationship with the Principal Investigators (PIs) in your department to effectively manage research studies, with the National Clinical Trials Network (NCTN) Departments, with the Duke Cancer Institute (DCI) & OncCRU administrative teams, & the department staff. Build & maintain effective relationships with key study personnel, clinical resources & regulatory colleagues within the OncCRU.
Serve as an assistant to RPM within OncCRU with oversight of peers and delegation of project related tasks to others on the study, knowledgeable of various funding sources including industry or federal grants. Supervise the day-to-day operations of the OncCRU related to study conduct.
Manage the day-to-day assignments, work schedule, work location, approve time, approve time off requests, do the yearly evaluations and promptly address performance issues for the NCTN staff. . Responsible for providing written documentation to employees and DCI Human Resources as needed. Responsible for ensuring each employee has a written, specific, individual position description that reflects the unique needs of NCTN.
Responsible for knowing what trainings, certifications and licenses are required for the NCTN staff to be compliant with the Joint Commission, Internal Review Board (IRB), Federal Regulations, Duke Regulations, Duke Office of Clinical Research (DOCR), SOPS, and study protocols. Responsible for providing documentation of trainings, certifications and licenses as needed to the DCI HR, OncCRU and leadership.
Confer with PIs in developing plans and protocols for clinical research studies and to discuss the interpretation of results and the preparation of manuscripts for publication.
Serve as an expert resource to PIs, study coordinators and other research staff with regard to study-specific protocol requirements and problem-solving related to clinical, logistical, financial and regulatory issues.
Assist PIs, the RPM, study coordinators and research staff in the development of subject recruitment strategies, identification of barriers to enrollment, and implementation of appropriate interventions.
Provide NCTN with clinical expertise, performing and coordinating protocol in-service to the Oncology Treatment Center nurses and inpatient Oncology staff.
Plan and coordinate staffing needs based on current and future workload requirements.
Ensure clear clinical direction has been provided to all clinical staff regarding all components of each protocol at onset of study implementation and with each study amendment and update.
Collaborate with the study coordinators and team leads to evaluate study staff's ability to execute study components (eligibility, documentation, data collection, regulatory functions, monitor query response, etc.) effectively and efficiently.
Review the finances of ongoing trials on a monthly basis in conjunction with your department leadership, OncCRU Director, PIs, Financial Manager and study coordinators.
Ensure information and data is collected from patient charts and records, patient interviews and other sources; collected data is evaluated and interpreted and protocol summary forms, statistical reports and analyses setting forth progress, adverse trends and appropriate recommendations or conclusions are prepared accurately and timely.
Provide protocol specific service to patients within the age group 18-65 and over.
Enter Maestro Care information at the time of enrollment, linking the patient to the Research Subject Record (RSH) record, to the study encounter and the timeline prior to close of the study encounter. Maintain current enrollment logs on all consented studies.
Ensuring regulatory duties are done in full compliance of all regulations.
Ensure all regulatory documentation is prepared and processed through the Institutional Review Board (IRB) and other entities as required, including amendments, continuing reviews, and adverse event reporting.
Monitor and ensure all consented patients are entered into the Clinical Trials Management System (CTMS) - currently eResearch/Velos - within School of Medicine policy deadlines. Monitor and ensure all Oncology required fields are entered into the CTMS to facilitate the annual DCI reporting requirements.
Monitor and ensure all actively enrolling studies are published on the DCI website and promptly remove studies not actively enrolling from the DCI website.
Perform monthly QI processes, consistent with OncCRU initiatives.
Participate in audits conducted by the QARC group, sponsors, and regulatory authorities. Review and respond to audit reports, and develop and implement corrective action in a timely manner when problems in research practice are identified.
Ensure coordination and preparation of monitoring visits, timely query follow up/completion and MIST review (calendar request and follow up report on the MIST shared network drive).
Conduct and coordinate OncCRU QA audits for NCTN.
Ensure all regulatory documentation are prepared and processed with pharmaceutical companies and clinical research organizations (CROs).
Other work as assigned by your manager.
Attend required clinical research, Clinical Research Coordinator (CRC) and departmental staff meetings.
Participate in, complete, and stay current in designated and required training [Clinical Research Unit (CRU), CITI modules, MaestroCare, Beacon, IRB, etc.]
Effectively manage your workload, seeking help whenever it's needed. Communicate frequently with your manager, keeping them up-to-date on your work and issues as they arise. You will work closely with your manager to implement departmental & Duke Policy and initiatives.
Adherence to core work hours; time off requests will be submitted to your manager per departmental & Duke Policy. Patient care is our primary mission. When the unexpected happens you may be called upon to provide coverage outside your core work hours.
Know and comply with the regulations, rules and SOPs for your department, Duke Medical Center, Duke Hospital, School of Medicine, OncCRU, DOCR and the Office of Research Administration (ORA).
Comply with Duke's rules, regulations and responsibilities as noted in The Duke Employee Handbook and on the Duke HR website.
The above statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required.
1045 ASSIST 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 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.
Allied Health degree or Associates degree in Clinical Trials Research and 8 years of related experience, with at least four years in a research setting. ACRP or SOCRA preferred. OR RN or Bachelor's degree and 6 years of related experience, with at least four years in a research setting. ACRP or SOCRA preferred. OR Master's degree and 4 years of related experience, with at least two years in a research setting. ACRP or SOCRA preferred.
No experience is required beyond what is specified above.
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.