ASSIST RESEARCH PRACTICE MANAGER
ASSIST RESEARCH PRACTICE MANAGER
DCI OFFICE OF RESEARCH SUPPORT
This is 100% sponsored funded.
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 that Clinical Research Coordinators (CRC) 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), OncCRU policy and 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. This entails being available on a routine basis during normal business hours to answer questions, provide leadership, mentor staff, and facilitate team work & communication. Your communication should be professional, clear and responsive. Supervise the day-to-day operations of the OncCRU related to study conduct.
You will manage the Breast Oncology Clinical Research (Breast) staff.
You are responsible for knowing what trainings, certifications and licenses are required for the Breast 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. You are responsible for ensuring all Breast staff are current on their required training and all required licenses are current. In the event there is a lapse you will promptly report it as appropriate and work with the OncCRU RPM and DCI HR to correct the situation.
You will ensure staff is cross-trained as appropriate to help ensure the conduct of studies is continuous and patients are provided the best treatment, care and safety.
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 Breast 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.
Review the finances of ongoing trials on a monthly basis in conjunction with your department leadership, OncCRU Director, PIs, Financial Manager and study coordinators. Facilitate efforts to address budget-related issues.
Provide protocol specific service to patients within the age group 18-65 and over.
You are responsible for 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.
Perform monthly QI processes, consistent with OncCRU initiatives. Participate in audits conducted by the CTQA 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. Conduct and coordinate OncCRU QA audits for Breast.
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.
As a licensed RN, you are expected to 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 that 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; maintain interface with nursing and other professional personnel to interpret protocol application for a given patient and to answer questions about the study in progress.
Confer with patient and attending physician to explain purpose of study and obtain written consent for patient to participate; explain diagnostic procedures and method of treatment to alleviate patient and family concern.
And other work as assigned.
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
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), Human Subject Research (HSR), CITI modules, MaestroCare, Beacon, IRB, etc.]
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.
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.
The preferred candidate will have clinical trial and oncology experience.
Breast Oncology experience is especially valuable to this position.
Basic Computer Proficiency required; capable of working with email, databases and Microsoft Office.
Excellent written and oral communication skills required to communicate and establish effective working,
collaborative relationships with multiple groups and diverse personalities.
Project Management skills required to manage & prioritize multiple, competing responsibilities.
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.