Monopar Therapeutics, Inc.; Wilmette, IL April 2022 – Present
Senior Clinical Research Associate
- Mentored and trained contract monitors on protocol, monitoring, and company strategy
- Managed and implemented monitoring strategy for a team of 7 contract monitors
- Managed each monitor’s deliverables to ensure company goals are met
- Reviewed monitoring reports to ensure site activities and compliance is being reported clearly and accurately
- Conducted the following types of monitoring visits: Pre-study, Site initiation, interim, and closeout
- Therapeutic Area/Phase: Oncology/Phase 2b/3 and 1b
Exicure, Inc.; Chicago, IL
Senior Clinical Research Associate September 2020 – March 2022
- Provided sponsor oversight for: site selection, monitoring, site issue mitigation, development and continuing review of project plans, site start-up, executive steering committee development, attend study specific meetings, and contract execution.
- Reviewed monitoring reports for assurance that CRO staff is monitoring and documenting site activities clearly and accurately
- Liaison between vendors, CRO, and Exicure’s management team.
- Co-managed vendor selection for expanding the current studies.
- Therapeutic Area/Phase: Oncology/1b/2 and 3; and Rare Disease/2
Xeris Pharmacueticals, Inc.; Chicago, IL
Clinical Research Associate January 2020 – August 2020
- Conducted routine and close-out monitoring visits
- Trained and mentored colleagues on monitoring practices
- Developed, implemented, and managed end of trial monitoring strategies to achieve study timelines and objectives
- Created a more robust monitoring program
- Ensured trial master files were inspection ready
- Acted as the main contact for investigational sites
- Therapeutic Area: Endocrine/1 and 3
Aptinyx, Inc (Previously Naurex Inc.); Evanston, IL
Senior Clinical Research Associate March 2019 – November 2019
Clinical Research Associate – Internal June 2016 – March 2019
- Administered clinical study plans and monitored progress to revise as necessary
- Oversaw study progress according to internal and vendor quality standards, SOPs, GCP, and ICH guidelines to fulfill all federal and local regulations
- Collaborated with study team to achieve successful execution and completion of clinical studies
- Coordinated cross-functional teams and worked with major functional area leads to identify, mitigate, and escalate project issues
- Ensured solutions to clinical study issues were implemented in a timely and efficient fashion
- Evaluated progress across teams to ensure over 85% of milestone achievements were met
- Developed clinical study protocols and study designs
- Created and maintained trial master files for assigned projects through collaboration with investigative site and field monitoring personnel to ensure audit readiness
- Conducted Pre-Study, Site Initiation, Routine Monitoring, and Study Close-Out visits, including the development of report templates and monitoring tools for site visits
- Finalized and negotiated project contracts across financial, legal, and clinical teams
- Trained and continuously mentored new team members
- Curated vendor and site selection
- Introduced company SOPs, Work Instructions, and Flow Charts
- Therapeutic Area/Phase: Mental Health/1 and 2; and Neurology/2
Quality Assurance Technical Specialist, Clinical February 2015 – June 2016
- Edited standard operating procedures, change control requests, and training materials as directed by
Quality Management for quality impact to GCPs
- Oversaw employee training records
- Synchronized efforts between functional groups to ensure compliance and overall clinical objectives
- Orchestrated internal/external due diligence, compliance, and CRO/Vendor qualification audits against regulatory authorities
- Facilitated employee training through collaboration with multiple training vendors and consultants
- Audited sites and vendors through individualized custom plans
Advanced Clinical; Deerfield, IL
In-House Clinical Research Associate July 2014 – February 2015
- Conducted in-house clinical monitoring tasks for Phase I, II, and III clinical trials
- Spearheaded processes that provided a more effective review of study documents
- Co-led the creation of a clinical monitoring application system
- Produced a manual to navigate through the clinical monitoring application for current and new employees
- Functioned as a liaison between different departments - including data management, regulatory, clinical monitoring, and project management
- Aggregated study start-up documents for clinical trials
- Conducted routine monitoring visits
- Reconciled data sets between the Master Project Workbook, Document Reconciliation Workbook, Clinical
Monitoring Reports, and the Electronic Data Capturing System
- Therapeutic Area/Phase: Dermatology/2; Reproductive/3
The University of Chicago; Hyde Park, IL
Clinical Research Associate 1 (Study Coordinator) February 2013 – July 2014
- Managed, maintained, and coordinated clinical oncology trials with research teams, outside institutions,
and sponsors to standards of all applicable regulatory agencies
- Assured data entered into EDC systems meet ALCOA-plus framework
- Created a Clinical Research Associate training manual
- Resolved queries administered from doctors, research staff, CRAs, and medical monitors
- Scheduled and ordered tests by coordinating with inside and outside departments and institutions mandated by research protocols required at specified time points
- Created source documents through utilization of study protocols and EDC systems
- Setup and lead meetings including site initiation visits, monitoring visits, close-out visits, and data safety monitoring with multiple departments at the institution
- Conducted a gap analysis between institution’s SOPs and the actual procedures and practices required by study protocols
- Therapeutic Area/Phase: Oncology/1, 2, and 3
Hoffman-Barrington Internal Medicine Specialist; Hoffman Estates, IL
Administrative Assistant September 2011-May 2013
- Scheduled patients for appointments
- Liaison between nurses, doctor, and patients
- Prepared patient charts for upcoming appointments
- Collected and prepared data inquired by third party organizations for case studies
- Performed document audits on policies and procedures in regards to patient administration
