Clinical Safety Analyst Research Nurse 4 (3580N4) The Division of Biostatistics, School of Public Health seeks a 100% time Clinical Safety Analyst to join their clinical research study team. This team is responsible for conducting statistical and data management activities for a large international clinical trial network (over 200 sites in 35 countries) according to government regulations, ICH GCP guidelines, protocol/investigational plan, and IRB and institution specific standards, guidelines and policies. The Clinical Safety Analyst has responsibility for supporting the study team primarily in drug safety monitoring, clinical endpoint validation, and management of clinical data. Duties include: conducting the day-to-day operations of pharmacovigilance; coordinating the activities of an endpoint review committee; coordinating the activities of a clinical study; and coding medical information.
1. Pharmacovigilance: (40 % of time) Develop, implement, evaluate, and maintain all components of a drug safety monitoring system (detection, collection, assessment, and monitoring) to ensure adverse effects of study pharmaceutical products are promptly identified and comprehensive information is available to all stakeholders in accordance with regulatory and contractual requirements: • Design data collection tools (CRFs), ensuring study, regulatory, and contractual requirements are met and data is appropriately structured for analysis • Triage incoming adverse event (AE) case report forms (CRFs) from study sites in order to fulfill regulatory and contractual timelines, • Process AE CRFs, evaluating for accuracy, completeness, and adherence to protocol-specific and GCP guidelines, • Create queries regarding CRF omissions, errors, inconsistencies, and requests for additional information, and contribute to clarification and resolution of discrepancies, o Enter clinical data into databases, o Prepare and submit Suspected Unexpected Serious Adverse Reaction reports to o international regulators, • Write safety reports (summarize data) and distribute to international regulators, network and pharmaceutical partners, o Prepare and distribute AE reports to pharmaceutical partners, o Perform reconciliation of safety database with pharmaceutical partners, o Receive and maintain tracking database of safety information provided by pharmaceutical partners, • Write, review, and edit drug safety monitoring reference, training, and meeting materials, . Serve as first point of contact for research network staff and outside partners regarding safety-related repofting issues.
2. Endpoint review committee coordination: (40 % of time) Develop, implement, evaluate, and maintain all components of a clinical endpoint reporting and review system (detection, collection, assessment, and monitoring) to ensure endpoint identification and high quality data for reporting statistical information to all stakeholders within established timelines: • Coordinate the activities of an international committee of physicians charged with verifying protocol-defined clinical endpoints, including cause of death • Develop case definition criteria for clinical outcomes, periodically monitoring against clinical standard of care, modifying case criteria as appropriate, • Design data collection tools (CRFs), ensuring that study requirements are met and data is appropriately structured for analysis, • Write, review, and edit clinical endpoint reporting reference, training, and meeting materials, • Process clinical endpoint CRFs, evaluating for accuracy, completeness, and adherence to protocol-specific and GCP guidelines, • Create queries regarding CRF omissions, errors, inconsistencies, and requests for additional information, and contribute to clarification and resolution of discrepancies, • Enter clinical data into databases, o Prepare supporting documentation for endpoint committee review, ensuring comprehensive information is available for endpoint validation, o Serve as point person for providing subject matter expertise in clinical endpoint reporting.
3. Code de-identified medical information: (10 % of time) Code clinical data across all reporling platforms (e.9., adverse event, cause of death, medical history, health-care utilization, and other data as appropriate) using standardized terminologies (MedDRA, ICD-10, and other coding dictionaries as required): • ldentify study-specific medical information for coding, • Code and verify medical information in accordance with established coding policies and procedures, • Perform coding dictionary database version maintenance processes, • Conduct quality control via periodic internal coding consistency review, • Represent study team on cross-network coding committee responsible for developing, maintaining, and enforcing coding policies and procedures, • Serve as primary point person for providing subject matter expertise in medical coding. • Represent the network on cross-center coding working group.
4. Miscellaneous Duties (10%) • Collaborate with a quality oversight and performance evaluation committee to monitor and improve adverse event, clinical endpoint, and protocol sub-study associated data quality and protocol/regulatory adherence metrics.
The University of Minnesota offers a comprehensive benefits package including:
· Competitive wages, paid holidays, vacation and sick leave · Low cost medical, dental, and pharmacy plans · Health care and dependent daycare flexible spending accounts · Excellent retirement plans with employer match · Disability and employer paid life insurance · Wellbeing program with reduced insurance premiums · Tuition reimbursement opportunities covering 75%-100% of eligible tuition · Student loan forgiveness opportunity · Opportunities for growth and promotion · Employee Assistance Program
For more information regarding benefits: https://humanresources.umn.edu/sites/humanresources.umn.edu/files/2020_tcd-cslr-75100-ben-0105-7_cs_final.pdf
Required Qualifications: • BS degree in Nursing with at least 5 years of experience or a combination of related education and work experience to equal nine years. • Current Registered Nurse (RN) licensure. • Demonstrated excellent written and spoken communication skills and organizational skills • Demonstrated capability for self-directed work that may have rapidly-changing requirements and/or priorities • Comfort using web-based applications/technology
Preferred Qualifications: • Experience with MedDRA coding
Internal Number: 337490
About University of Minnesota, Twin Cities
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.