Rick Harrell Email & Phone Number

Kansas City Metropolitan Area

Regionally-Based

• Conducted unblinded and oncology trials in Phases I – III
• Inspired team engagement to achieve 2 final database locks, 2 interim database locks, last unblinded vial reconciled early, and central files delivery (all on-time or early).
• Designed and evolved unblinded Excel spreadsheet solutions to maintain the blind outside of existing systems yet within standard operating procedure requirements. Implemented VBA programming macros, complex equations.
• Led initiative to collaborate on standardizing trial master file guidance across a 5-protocol program
• Successfully represented unblinded contributions in an on-site sponsor audit and finalized its response. Assisted with finalization of prior EMEA regulatory audit response and feedback for process improvements
• Delegated and oversaw tasks assigned to new Associate Lead trial counterparts and trained new CRAs, with a focus on approachability, quality, and appreciation of the human element

Regionally-Based

• Successfully managed the translation of central unblinded files to a new Sponsor-requested folder structure, while the study was ongoing
• Built client confidence and business development through dedicated tenacity, a reduction in the new role’s learning curve, applied team-oriented strategies, and was appointed primary Clinical Lead on 2 trials in less.
• Promoted to full Clinical Operations Lead after one year in role

Regionally-Based

• Specialized in Hematology-Oncology Clinical Research Trials
• Identified and successfully resolved significant site quality issues and procedures through a rigorous on-site schedule and regular conferences with the client
• Site relationships and resolution of quality issues contributed to achieving Subject enrollment ahead of schedule and on-time interim database lock for the same trial
• Mentor and training partner to new CRAs (one of which grew from CRA-I to Sr. CRA during trial leadership tenure)
• Promoted to competitive Associate Clinical Lead position within one year of hire

Kansas City, Missouri Area

• Granted Lead CRA role on a specialized Phase-I trial, based on cross-department flexibility
• Beta-tested new internal systems and acted as a clinical expert to various departments in the development, content, innovation, certification, and accurate implementation of chosen systems
• Mentored, trained, and evaluated several new CRA candidates
• Therapeutic areas of expertise: Oncology, Cardiovascular, Immunology, Diabetes

Regionally-Based

• Contract, on-site CRA for a complex, pivotal cardiovascular trial
• Gained insight in the successful operation of a small business

Regionally-Based

- Performed clinical monitoring in compliance with FDA regulations, GCP/ICH guidelines, and all company-related SOPs- Coordinated collection of information from investigational sites, completed trip reports- Managed, monitored, and generated reports for clinical trials

Kansas City, Missouri Area

• Executed all stages of Phase-I clinical trials, from feasibility to close-out
• Frequently communicated directly with the Sponsor, adapted new protocols, designed case report forms, generated clinical management plans and related documentation, observed first dose per cohort, provide oversight of.

Kansas City, Missouri Area

• Selected by Project Management to orchestrate data listing reconciliation for specialized internal and vendor data, based on exceptional performance as a program CRA
• Achieved on-time database lock for all assigned data sets within a 14-protocol program, despite a compact series of deadlines
• Performed all clinical monitoring visit types for Phases II-III, in compliance with FDA regulations, GCP/ICH guidelines, and all company-related SOPs, for sites in all regions of the U.S. and Canada
• Actualized brisk and precise visit reports, fulfilled correspondence and document management with assigned sites, enhanced follow-up communication, and developed a diplomatic rapport to bolster relationships with site.