Thoracic Clin Rsrch
Participate in clinical research studies conducted by principal investigators (PIs) for the Duke Cancer Institute's (DCI) Oncology Clinical Research Unit (OncCRU) for the Thoracic Team. Perform study-specific regulatory and safety reporting processes across multiple studies including multi-site, in accordance with appropriate regulations, institutional policies, Standard Operating Procedures (SOPs), and study- specific protocols, plans and processes under the direction of a supervisor.
Clinical Research Operations,- Independently develop and submit Institutional Review Board (IRB) documents such as consent forms, protocols, and continuing reviews. May train junior staff in this area. Maintain or collaborate to maintain appropriate study- level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc.
Assist with the development of and provide the appropriate regulatory reports and associated documentation in accordance with SOPs and study specific processes under the direction of the supervisor. Provide routine updates and reports to ensure timely communication regarding status of regulatory and/or important safety related issues.
Prepare for study monitoring and study audit visits. Assist with addressing and correcting findings from study monitoring and study audit visits.
Collect, prepare or process adverse event information independently. Complete and submit Adverse Events Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) under supervision or may do independently.
Have familiarity with intellectual property rights, inventions, patents and technologies. As appropriate, understand regulations related to investigational products with sponsors. Recognize the need for agreements (e.g. Material Transfer Agreements, Investigational New Drug Applications, etc).
Data Management and Informatics, - Enter protocol specific data into required institutional or protocol-specific systems. Review study specific data listings and reports for quality and accuracy.
Leadership and Professionalism,-Actively network and encourage and support colleagues to complete project work. Assist research colleagues in identifying efficiencies and improving process.
May serve as mentor to other staff. May assign, review, and train others in various work responsibilities. May provide constructive feedback to other team members. Employ escalation and performance plans as needed.
Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research. May be responsible for summarizing and clarifying for study teams, the professional guidelines and code of ethics related to the conduct of clinical research.
Maintain Duke- and project- specific training requirements. May develop solutions to proactively ensure study team's compliance with training requirements.
Encourage career development by actively seeking out continuing education opportunities for self and study team members.
Study and Site Management, - 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 and closeout meetings independently. Take part in or lead closeout and document storage activities.
Communication and Team Science,- Communicate concerns clearly and in a professional manner. Recognize when others need to be brought into the conversation and escalate appropriately.
Work closely with sponsor and study personnel on relevant regulatory and/or safety issues.
Take action when communication has stalled with sites, CROs, or sponsors. Participate in study team meetings. Communicate and coordinate with other study personnel as required for study implementation and routine problem solving.
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.
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.
1219 REGULATORY COORD
Job Family Level
Full Time / Part Time
Regular / Temporary
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1.Completion of a bachelor's degree. 2.Completion of an Associates degree plus a minimum of two years of research and/or regulatory experience.
The preferred candidate will have oncology, science background or research experience, training, education. Excellent organizational, written and communication skills. Prior regulatory experience helpful but not required.
Can easily use computing software and web-based applications (e.g., Microsoft Office products and the electronic medical record).
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.