Duke University
Regulatory Coordinator
Duke University, Durham, North Carolina, United States, 27703
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.
Occupational Summary
Preform regulatory and safety processes for multiple, complex oncology clinical trials and research studies including Investigational Products [IP] for the Duke Cancer Institute's [DCI] Phase I Clinical Research Program [PH1]. The Oncology Clinical Research Unit [CRU] oversees the conduct of research.
Work Preformed
Operations, Study and Site Management - 45% Effort
Develop and submit Institutional Review Board [IRB] documents such as consent forms, protocols, and continuing reviews. Maintain study level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc. Provide regulatory and safety reports.Maintain study compliance according to institutional requirements, protocols and other applicable policies such as NIH Public Access policy, ct.gov, and Research Data Security Plans.Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties.Work closely with study sponsors on regulatory and safety issues.Prepare for study monitoring and study audit visits. Assist with addressing and correcting findings from study monitoring and study audit visits.Complete and submit Adverse Events Reports, according to institution and sponsor-specific reporting requirements [timelines and forms].Communication - 25% Effort
Collaborate, and communicate with other study personnel as required. Communicate concerns clearly in a professional manner. Respond timely to emails, phone calls and questions. Refer more complex questions and escalate issues to others as appropriate.
Data -5% Effort
Use Electronic Data Capture (EDC) systems and enter data accurately. Review study specific data listings and reports for quality and accuracy.
Leadership - 5% Effort
Actively network. Provide leadership within the team. Actively and proactively participate in team meetings, committees, task forces and ad hoc groups.Encourage career development by actively seeking out continuing education opportunities. Participate in scientific presentations and publications.Serve as an expert resource for colleagues and teammates. Mentor staff, including those in the same job title. Support colleagues in their project work; encourage completion.Ethics - 20% Effort
Summarize and clarify for study teams, the professional guidelines and code of ethics related to regulatory and safety issues in the conduct of clinical research.Know and follow policies, standard operating procedures (SOPs), regulations and protocol requirements that govern clinical research. Maintain Duke and project specific training and certification requirements.
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. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Minimum Qualifications Required At This Level
Education
Completion of an Associate's degree
Experience
Work requires a minimum of two years of research and/or regulatory experience. experience. A Bachelor's degree may substitute for 2 years of required
Preferences
The preferred candidate will have oncology or research experience, training, education.
Job Code: 00001219 REGULATORY COORDJob Level: 52
Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, genderexpression, 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 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.
Occupational Summary
Preform regulatory and safety processes for multiple, complex oncology clinical trials and research studies including Investigational Products [IP] for the Duke Cancer Institute's [DCI] Phase I Clinical Research Program [PH1]. The Oncology Clinical Research Unit [CRU] oversees the conduct of research.
Work Preformed
Operations, Study and Site Management - 45% Effort
Develop and submit Institutional Review Board [IRB] documents such as consent forms, protocols, and continuing reviews. Maintain study level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc. Provide regulatory and safety reports.Maintain study compliance according to institutional requirements, protocols and other applicable policies such as NIH Public Access policy, ct.gov, and Research Data Security Plans.Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties.Work closely with study sponsors on regulatory and safety issues.Prepare for study monitoring and study audit visits. Assist with addressing and correcting findings from study monitoring and study audit visits.Complete and submit Adverse Events Reports, according to institution and sponsor-specific reporting requirements [timelines and forms].Communication - 25% Effort
Collaborate, and communicate with other study personnel as required. Communicate concerns clearly in a professional manner. Respond timely to emails, phone calls and questions. Refer more complex questions and escalate issues to others as appropriate.
Data -5% Effort
Use Electronic Data Capture (EDC) systems and enter data accurately. Review study specific data listings and reports for quality and accuracy.
Leadership - 5% Effort
Actively network. Provide leadership within the team. Actively and proactively participate in team meetings, committees, task forces and ad hoc groups.Encourage career development by actively seeking out continuing education opportunities. Participate in scientific presentations and publications.Serve as an expert resource for colleagues and teammates. Mentor staff, including those in the same job title. Support colleagues in their project work; encourage completion.Ethics - 20% Effort
Summarize and clarify for study teams, the professional guidelines and code of ethics related to regulatory and safety issues in the conduct of clinical research.Know and follow policies, standard operating procedures (SOPs), regulations and protocol requirements that govern clinical research. Maintain Duke and project specific training and certification requirements.
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. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Minimum Qualifications Required At This Level
Education
Completion of an Associate's degree
Experience
Work requires a minimum of two years of research and/or regulatory experience. experience. A Bachelor's degree may substitute for 2 years of required
Preferences
The preferred candidate will have oncology or research experience, training, education.
Job Code: 00001219 REGULATORY COORDJob Level: 52
Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, genderexpression, 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 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.