ASSIST RESEARCH PRACTICE MANAGER
ASSIST RESEARCH PRACTICE MANAGER
DCI OFFICE OF RESEARCH SUPPORT
Responsible to the Oncology Clinical Research Unit (OncCRU) Research Practice Manager (RPM) for 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 Clinical Research Coordinators (CRC) & designated research personnel are performing study activities in accordance with Good Clinical Practice (GCP), Duke Policy and Regulatory requirements using Standard Operating Procedures (SOPs), Onc CRU policy & periodic monitoring.
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.
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 Gyn and Sarcoma staff. Collaborate closely with the RPM & DCI Human Resources team to carry out these responsibilities.
Meet regularly, monthly at a minimum, with direct reports, individually, to discuss their work, needed improvements, priorities, give performance feedback & talk about their concerns. At least quarterly, provide expectations & feedback on their performance.
Responsible for knowing what trainings, certifications & licenses are required for the Gyn & Sarcoma staff to be compliant with the Joint Commission, Internal Review Board (IRB), Federal Regulations, Duke Regulations, Duke Office of Clinical Research (DOCR), SOPS, & study protocols. Responsible for ensuring all Gyn & Sarcoma staff are current on their required training & required licenses are current. Responsible for providing documentation of trainings, certifications & licenses as needed to the DCI HR, OncCRU and leadership.
Ensure staff is cross-trained as appropriate to help ensure the conduct of studies is continuous & patients are provided the best treatment, care & safety.
Confer with PIs in developing plans & protocols for clinical research studies &to discuss the interpretation of results & the preparation of manuscripts for publication.
Serve as an expert resource to PIs, study coordinators & other research staff with regard to study-specific protocol requirements & problem-solving related to clinical, logistical, financial & regulatory issues.
Assist PIs, the RPM, study coordinators & research staff in the development of subject recruitment strategies, identification of barriers to enrollment, & implementation of appropriate interventions.
Ensure clear clinical direction has been provided to all clinical staff regarding all components of each protocol at onset of study implementation & with each study amendment & update.
Collaborate with the study coordinators & 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. Using that evaluation assistant in the establishment of specific study assignments for each staff member at the onset of each study (clinical, regulatory & data functionality). With the team leads & study coordinators regularly review staff performance & workload and adjust assignments accordingly.
Enter Maestro Care information at the time of enrollment, linking the patient to the Research Subject Record (RSH) record, to the study encounter & the timeline prior to close of the study encounter. Maintain current enrollment logs on all consented studies.
Responsible for ensuring regulatory duties are completed in full compliance of all regulations.
Ensure all regulatory documentation is prepared & processed through the Institutional Review Board (IRB) & other entities as required, including amendments, continuing reviews, & adverse event reporting.
Monitor & ensure all consented patients are entered into the Clinical Trials Management System (CTMS) - currently eResearch/Velos - within School of Medicine policy deadlines. Monitor & ensure all Oncology required fields are entered into the CTMS to facilitate the annual DCI reporting requirements. Monitor & ensure all patients statuses in CTMS are updated as appropriate (consented, enrolled, end billing, etc.)
Monitor and ensure all actively enrolling studies are published on the DCI website and promptly remove studies not actively enrolling from the DCI website.
Monitor and ensure clinicaltrials.gov documentation is accurate and updated per Duke Guidelines.
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).
Ensure all regulatory documentation are prepared and processed with pharmaceutical companies and clinical research organizations (CROs). Ensure timely resolution of regulatory related queries with IRB, study sponsors, and CRO. Participate in the conduct of audits by study sponsors, CROs, the FDA, and other groups as needed.
Administer medication, physical medication, take doctor's orders, conduct unscripted interviews, evaluate clinical data, complete physical assessments, make judgments based on your assessment of patients, consent patients through informed consent; collect, interpret, and document data.
Ensure patient treatment provided by primary care personnel and data collected adhere to study protocol; screen patients for inclusion in study based on pre-determined criteria; maintain inventory of unique drugs and supplies needed for study; provide basic patient care and treatment as requested by the physician.
Obtain patient blood samples, cultures, tissues and other specimens for laboratory analysis; initiate drug orders and laboratory studies for patients based on standing protocol orders.
Provide direction and training to nursing staff on techniques for mixing and administering new drugs and other forms of patient care and treatment unique to the study being conducted.
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.
The intent of this job description is to be representative of the level and the types of duties and responsibilities that will be required of this position and shall not be construed as a declaration of the total specific duties and responsibilities. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
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 are search setting. ACRP or SOCRA preferred.O RRN 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.