Develop, coordinate,and implement monitoring strategies essential to the successful management of Oncology clinical trials conducted by Principal Investigators (PIs)at the Duke Cancer Institute(DCI).
Ensure the protection and safety of research subjects.Educate PIs and research professionals on the conduct of oncology clinical trials.Ensure the quality and integrity of data with respect to accuracy,accountability, documentation,and adherence to procedures through review of case report forms (CRFs),source documents,medical records, and regulatory documents.Ensure studies are conducted in accordance with the protocol, Standard Operating Procedures SOPs), Good Clinical Practice (GCP), and applicable regulations.
RESPONSIBILITIES AND EXPECTATIONS
Assess study status and accrual using available databases and systems e.g. eIRB, eResearch, iRIS, OnCore, Epic to identify protocols requiring monitoring and safety oversight and to ensure all subjects signing consent are registered in eResearch, Oncore or Epic.
Maintain up-to-date electronic and paper monitoring management systems.
Schedule and coordinate monitoring visits.
Prepare for monitoring visits.
Review protocol/research documents;Review electronic databases for regulatory and toxicity documentation and subject registration;Prepare appropriate monitoring documents.
Assist in the conduct of internal and external, clinical and regulatory monitoring: Pre-study; Site Initiation; Routine; Close-out; Requested; Investigational Drug Accountability.
Review study files, paper/electronic CRFs, and data collection toolsfor accuracy, legibility and consistency.
Verify data entries with source.Advocate the protection and safety of subjects.
Assist in Safety Oversight Committee (SOC) meeting preparation and contributes to SOC meeting discussion.
Provide feedback and education to study teams to facilitate successful protocol management.
Complete monitoring reports.
Review PI and study team response to monitoring reports to ensure a satisfactory response or plan.Identify site deficiencies and provide assistance with developing,implementing and evaluating Corrective and Preventive Action Plans (CAPAs).Contribute to the ongoing development and improvement of forms, tools,templates and processes.
The ideal candidate will have one a background in at least one of these: Nursing, Oncology Background, Clinical Research Background or Clinical Trials Monitoring.
Excellent written, oral and conversational communication skills to effectively work with diverse groups.
Ability to analyze,evaluate multiple solutions and solve complex problems using well developed critical & analytical thinking skills.
Excellent time management skills needed to prioritize among many competing priorities.
Attention to detail needed to operate accurately and effectively in the regulatory environment.
Mastery of Microsoft Office.
And other work as assigned.
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, 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.
Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician's Assistant(PA) or Pharmacist plus one year of healthcare experience; or one of the following equivalents:Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of three years healthcare experience; or Completion of a master's degree in Public Health, Health Administration or a related area with no additional experience; or Completion of a bachelor's degree plus a minimum of one year directly related experience in clinical trials research; or Completion of a bachelor's degree plus a minimum of two years closely related research experience.**State of North Carolina license may be required.**
None required beyond that described above. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE