Renee Karabon
Grosse Pointe,MI
Summary
Accomplished Clinical Trial Manager at ICON, adept in clinical data management and fostering team collaboration. Excelled in enhancing data quality, achieving recruitment targets, and ensuring regulatory compliance. Proven track record in improving study outcomes and mentoring staff, demonstrating exceptional clinical trial oversight and interpersonal skills. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
9
9
years of professional experience
Work History
Clinical Trial Manager
ICON
08.2023 - Current
- Ensured that clinical trials are carried out within timelines and budgets and in accordance with Good Clinical Practices, ICH guidelines and Global and Local Standard Operating Procedures.
- Evaluated vendor performance regularly to ensure high-quality services were provided throughout the duration of the clinical trial.
- Improved data quality in clinical trials by overseeing data management activities such as data cleaning, validation, and database lock procedures.
- Developed training materials for site staff to enhance their understanding of the study protocol, resulting in improved adherence to requirements.
- Ensured compliance with regulatory guidelines by thoroughly reviewing protocols, informed consent forms, and other essential documents.
- Fostered strong relationships with investigative sites, leading to increased collaboration and improved study outcomes.
- Achieved successful recruitment targets by implementing strategic patient enrollment plans and collaborating with study sites.
- Managed cross-functional teams to ensure timely completion of clinical trial milestones and deliverables.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Clinical Research Associate
ICON
02.2021 - 08.2023
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Collaborated with cross-functional teams to successfully meet project timelines and deliverables.
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
- Enhanced data quality by closely monitoring study progress and ensuring accurate data collection.
- Mentored team members by sharing suggestions and encouraging ideas to deliver successful studies.
Clinical Research Coordinator
Beaumont Health
06.2015 - 06.2018
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Gathered, processed, and shipped lab specimens.
- Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
Education
Bachelor of Science - Allied Health Science
Grand Valley State University
Allendale, MISkills
- GCP Knowledge
- Adverse event reporting
- Clinical Data Management
- Training and mentoring
- Clinical Trial Oversight
- Patient recruitment
- Trial management
- Clinical trial expertise
Timeline
Clinical Trial Manager
ICON
08.2023 - Current
Clinical Research Associate
ICON
02.2021 - 08.2023
Clinical Research Coordinator
Beaumont Health
06.2015 - 06.2018
Bachelor of Science - Allied Health Science
Grand Valley State University
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