American College of Radiology
About the job
The American College of Radiology is a professional association serving over 40,000 members across the country. Consistent with the ACR’s mission to advance the practice of radiology and improve the health outcomes of the populations we serve, the ACR’s Center for Research and Innovation (CRI) has been a world leader in radiology clinical research for over 50 years. Over this period, the CRI has conducted clinical research trials and other research projects which have transformed the practice of radiology, informed the development of clinical practice standards, led to new device approvals, and changed healthcare policy.
The CRI serves as the core radiology resource for NCI multicenter clinical trials involving diagnostic or therapeutic radiology. And, through active research committees in neuroradiology, cardiology, oncology, and pediatrics, the CRI has developed and delivered a diverse range of research studies in partnerships with academia and with commercial sponsors. Research studies range from prospective clinical trials to retrospective reader studies, novel imaging methods and imaging software, validation of biomarkers, radiomic feature analysis, and AI algorithm development and validation.
Based on these strategic objectives, ACR is seeking a Clinical Data Manager – Adverse Event Coordinator to provide support to the ACR study initiatives across the College.
Principal Duties Include
- Performs medical review and reporting of protocol adverse events, endpoints, and eligibility. Reviews serious adverse events (SAEs) of patients enrolled in clinical trials in a timely manner.
- Tracking details for incoming Adverse Event reports. Triages adverse events to determine seriousness, expectedness, and priority, including accurate and timely response. Works with sites to correct non-compliance and escalates potential safety/compliance issues, reviews corrective and preventative action plans, as needed.
- Prepare case narratives and assign or evaluate appropriateness of MedDRA coding, including follow-up updates
- Participates with departmental teams in design, documentation, testing, and implementation of clinical research trials in an electronic data capture (EDC) system
- Designs and/or reviews electronic Case Report Forms (CRFs) with a focus on adverse event reporting, ensuring consistency with study protocol and clinical requirements.
- Participates on protocol teams and communicates to report on and resolve data management issues
- Support for SOP review, update, development
- Create standard, study specific, and ad hoc reports to support the data management of assigned clinical research trials.
- Reviews data submitted to EDC system for assigned clinical trials and/or projects, as required.
Qualified Candidates Will Possess The Following
- 2+ years of experience in data management and/or database design (experience in a clinical research setting is a plus)
- Drug safety / pharmacovigilance experience in a clinical setting experience
- Knowledge of MedDRA and Adverse Event Coding
- Understanding of regulations relevant the safety of drugs in development and post-authorization
- Healthcare certification/Bachelor’s degree preferred.
- Knowledge of MS Excel, Word, Access, and PowerPoint is essential.
- Ability to handle multiple tasks at one time and to work with minimal supervision.
- Excellent verbal and communication skills.
- Strong attention to detail is critical.
If you would like to put your experience to great use in a professional team-oriented environment, please apply online. To learn more about ACR’s rewarding employee experience, culture, and benefits, visit: https://www.acr.org/About-ACR/Work-With-Us
ACR offers a rewarding employee experience: innovative culture, professional growth potential, competitive compensation, and an exceptional benefits package, including a defined contribution pension plan, 403(b); generous paid time off package; insurance plans with the leading providers; flexible spending; tuition reimbursement; training opportunities; and wellness reimbursement.