Safety Surveillance Associate I
DCI OFFICE OF RESEARCH SUPPORT
Manage the receipt of and processing of all safety reports received from Investigator-Initiated and Industry-Sponsored clinical trials conducted by Principal Investigators (PIs) for the Duke Cancer Institute (DCI). This position will assist with designing, training, implementing and coordinating of trial-specific safety reporting and data reconciliation processes and procedures under direction of the safety team lead. Participate in general safety reporting training programs for the Oncology research community.
Design and Implementation of Trial Specific Safety Reporting Processes
- Participate in and assist with the development and implementation of standard DCI Safety Surveillance processes.
- Participate in discussions and assist in the design and implementation of trial specific safety reporting processes.
- Participate in daily processing of safety data across multiple trials (different therapeutic areas and phases).
- This includes creating, updating and maintenance of safety report documentation for review by PIs, sponsors, trial management and regulatory agencies.
- Assist in the oversight of serious adverse events (SAEs) and Investigational New Drug Safety Reports (INDSRs) into tracking systems and other applicable databases; ensuring information is accurate and complete.
- Assist with processing of the clinical trials safety reports from receipt to closure.
- Assist with the auditing of safety databases for quality control (QC).
- Ensure all safety related data is sent and received via the department specific email box.
Serious Adverse Events (SAE) Review and Reporting
- Perform high quality clinical review of serious adverse events and associated documents for completeness, accuracy, and appropriateness for expedited reporting.
- Write medically relevant clinical case narratives.
- Identify clinically significant information missing from reports and ensures its collection.
- Ensure SAE receives appropriate medical review and follow-up.
- Ensure all cases that require expedited reporting are processed swiftly and appropriately within required timelines.
- Ensure that safety reports are processed and reported in accordance with FDA regulations, ICH-GCP guidelines, and department Standard Operating Procedures (SOPs).
- Review INDSRs and if applicable, report to Duke Institutional Review Board (IRB).
- Assure compliance with Standard Operating Procedures (SOPs), Federal Drug Administration (FDA) guidelines and global regulations for reporting of adverse events to regulatory agencies.
- Assure compliance with trial-specific protocols; appropriate use of clinical investigator brochures and informed consent forms.
- Assist with QC of safety databases to monitor for quality data.
- Manage time effectively, prioritize workload, and remain compliant with regulatory timelines to consistently meet study deadlines.
Developing & Improving Processes, SOPs and Work Instructions
- Assist with creation of safety reporting processes educational materials.
- Assist with the development of safety desk SOPs, work instructions, trial-specific processes, and safety reporting databases and tracking systems.
- Assist in the development and implementation of internal training program for safety reporting and related activities and trial-specific safety data reconciliation processes.
- Assist with the design, testing and implementation of safety reporting databases and tracking systems and changes.
- Assist with monitoring of trial-specific deliverables, ensuring all deadlines are met.
- Assist with and participate in client or regulatory audits.
- Provide routine updates and reporting to Safety Surveillance personnel and management to ensure timely communication regarding status of safety data and important safety related issues.
Communication, Education & Training
- Build and maintain effective relationships with key trial personnel.
- Work closely with sponsor and trial personnel on relevant safety data issues.
- Communicate effectively with sponsors, sites and trial personnel to obtain high quality safety data in a timely fashion.
- Assist with training of safety surveillance personnel and other clinical research personnel on safety reporting regulations, processes, and procedures; on trial-specific processes, procedures and reporting regulations.
- Assist with reviewing trial-specific data listings and reports for quality and accuracy. Assist with providing trial-specific reports to trial personnel per trial-specific processes.
- Demonstrate commitment, dedication, cooperation, positive attitude, adaptability, and flexibility with changes in responsibilities and duties.
Requisition Number 401492863
Duke Entity MEDICAL CENTER
Job Code 1096 SAFETY SURVEILLANCE ASSOC I
Job Family Level 71
Full Time / Part Time FULL TIME
Regular / Temporary Regular
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 a Bachelors degree in clinical research, life sciences, or healthcare related field.
Work requires a minimum of one year of direct clinical research experience. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE.
2 years of clinical research or safety reporting experience.
- Ability to write and speak clearly and concisely in a variety of communication settings. Strong technical writing, editing, and proof reading skills.
- Good communication and interpersonal relationship skills needed to work with internal and external clients. Good presentation skills.
- Knowledge of drug and device safety data processing. Working knowledge of clinical research processes. Good working knowledge of 21 CFR 312.32 and 21 CFR 314.80 and ICH. Good Clinical Practices related to safety data processing. Strong knowledge of key medical terminology.
- Working knowledge of clinical trials safety event reporting regulations.
- Ability to read and understand medical source documents and to summarize them in a well-written narrative.
- Proficient in computer skills, including MS Word MS PowerPoint, and MS Excel.
- Ability to organize, plan, and execute work timely while maintaining quality standards. Excellent attention to detail. Ability to identify and resolve discrepancies.
- Flexibility with changes in responsibilities and duties (work priorities may change as more urgent safety reports arrive).
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