Pharmacovigilance and Regulatory Specialist

Job Summary

Meet with PI and study team to review the progress of the application and development of the subsequent trial, assist in the development of applicable protocol materials before submission to the FDA, review any adverse safety events, protocol deviations and exclusions, enrollment and follow-up of participants, missing data and data quality controls, and any new medical advances that may require changes in the study protocol to ensure adherence to the protocol and IND/IDE application. Work closely with the Medical Director and Principal Investigator in the development of the safety monitoring and related sections of the CTD. Direct communications and meetings about the clinical trial including regulatory compliance, scientific review committees, the manufacturing sites, the hospital-based research administration, and other entities on campus. Maintain document version control as updates and edits are made during the IND/IDE application process and throughout the protocol life cycle. Work with the Project Manager to elevate any significant barriers delaying the IND/IDE application and operationalizing of the protocol to the PI and OVCR leadership. Monitor e-mail for safety reports and facilitate a timely review by the Medical Director, coordinate with the FDA as applicable and ensure that safety reports with appropriate documentation are submitted to the applicable regulatory agencies in a timely fashion. Provide safety reports and other regulatory documents as needed to the Study Monitoring Committee prior to each meeting. Coordinate with the appropriate Study Monitoring Committee to ensure that all applicable safety reports are reviewed in accordance with their charter. Coordinate with the regulatory team to ensure that consistent information is submitted to all relevant review processes with oversight of safety data. Ensure that TMFs are compliant with all applicable federal guidance. Provide regulatory support for FDA submissions and interactions, as needed. Position is fully remote reporting to the University of Colorado Anschutz Medical Campus in Aurora, CO. Employee must appear in person at worksite at least once a month.

Work Location

Remote - Position is fully remote reporting to the University of Colorado Anschutz Medical Campus in Aurora, CO. Employee must appear in person at worksite at least once a month.

Why Join Us

CU Anschutz seeks a qualified candidate to join the newly developed IND/IDE Support Office. The mission of the office is to facilitate efficient start up processes for investigator-initiated research under FDA oversight, ensure that this research is feasible and appropriately resourced, alleviate administrative burdens on investigators, and mitigate compliance risks for the institution. This will be accomplished by providing robust and tailored centralized support for investigator-initiated IND and IDE submissions. The Pharmacovigilance Specialist will assess the safety of the research participants throughout the course of the trials for which the IND/IDE Support Office provides services and oversight. The Pharmacovigilance Specialist must have experience with clinical trials so that they can monitor the progress of the trial for adequate enrollment, appropriate follow-up, adherence to protocol, and good data collection. This position would work directly with the Medical Monitor, Principal Investigators (PIs) and closely coordinate with institutional partners including the Clinical Research Administrative Office, the IRB, clinical teams and manufacturing facilities as applicable.

Qualifications

Requires a Bachelor's degree in Regulatory Affairs, Pharmacy, Healthcare, Sciences, or a directly related field and three (3) years of clinical research experience. Must have experience in each of the following skills: Pharmacovigilance; Regulatory Affairs; Clinical trial regulatory work; Risk assessment and mitigation; Adverse event (AE) analysis; Databases: Trial Master File database, Oncore or other CTMS, Electronic Data Capture systems; Safety parameters, protocols, and reporting.