Erin Schulte
Cleveland,OH
Summary
Clinical Research Coordinator certified by the Association of Clinical Research Professionals (ACRP). Specializing in the coordination and execution of clinical trials for pharmaceutical products and other medical devices. Well-versed in ICH-GCP, clinical practice methods and procedures, as well as state and federal regulations related to research projects. Expertise in establishing and maintaining strong relationships with medical personnel, colleagues, and study patients, with a history of addressing questions and concerns in a timely manner. Experienced in multiple clinical study areas including oncology, bone marrow transplant, dermatology, metabolic diseases, gynecology, cardiovascular diseases, and psychiatry disorders.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Certified Clinical Research Coordinator III
Cleveland Clinic Taussig Cancer Center
09.2021 - Current
- Increased protocol compliance by providing comprehensive training and support to study team members.
- Collaborated with interdisciplinary healthcare teams to provide coordinated care, boost patient satisfaction, and promptly addressing needs during visits.
- Reduced study deviations by closely monitoring patient progress and promptly addressing any issues or concerns.
- Facilitated rapid resolution of complex issues related to study conduct or patient safety concerns through effective problem-solving skills.
- Supported positive relationships between patients and research teams through empathetic communication and compassionate care coordination efforts during clinical trials participation.
- Ensured timely completion of study milestones by effectively managing multiple competing priorities and deadlines.
Certified Clinical Research Coordinator
Clinical Neuroscience Solutions Healthcare
03.2019 - 08.2021
- Oversee all patient/research participant activities, including recruiting, screening and enrollment, providing safety support, and coordinating protocol-related research procedures, study visits, and follow-up care
- Developed strong professional connections among colleagues working together as a cohesive team producing high-quality results
- Attend investigator meetings with the Principal Investigator, study start-ups, and other administrative meetings
- Facilitate site initiation visits, routine monitor visits, and closeout visits with Sponsor/ CRO
- Streamlined regulatory submissions by efficiently preparing documentation, including informed consent forms, serious adverse event reports, and institutional review board materials.
- Provided critical support during audits or inspections by promptly addressing any concerns raised by regulators or sponsors regarding trial conduct or documentation practices.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
Certified Clinical Research Coordinator
ENCORE Research Group
01.2014 - 03.2019
- Collaborate with Principal Investigator and supporting study staff in the planning, managing, and execution of clinical trials in various therapeutic areas.
- Followed informed consent processes and maintained records.
- Maintain strict compliance with IRB-approved protocol, federal, state, and sponsor policies, as well as institutional policies, standard operating procedures (SOPs), and guidelines
- Obtained client medical history, medication information, and allergies.
- Maintain an open dialogue with research patients and their families, providing guidance through the informed consent process and education on protocol, study intervention, and study drugs
- Performed EKGs and other diagnostic tests, contributing to accurate and timely diagnoses.
- Collected and documented patient medical information such as vital signs, height and weight.
- Maintain patient binders, ensuring source documents are accurate to the current study protocol
- Maintain certifications and training records as required
Education
Bachelor of Science - Nutrition and Dietetics
Kent State University
Kent, OHSkills
- Electronic Data Capture
- ICH Guidelines
- Informed Consent Process
- Clinical trial management
- Research SOPs understanding
- Investigational product management
Certification
- Certified Clinical Research Coordinator (CCRC)
- Cardiopulmonary Resuscitation (CPR)
- ICH Good Clinical Practice (GCP)
- International Air Transport Association (IATA)
- Human Gene Transfer Certification
- Basic Biosafety Certification
- NIH Recombinant DNA (rDNA) Guidelines certification
- Personal Training Certification through American Council on Exercise (ACE)
Timeline
Certified Clinical Research Coordinator III
Cleveland Clinic Taussig Cancer Center
09.2021 - Current
Certified Clinical Research Coordinator
Clinical Neuroscience Solutions Healthcare
03.2019 - 08.2021
Certified Clinical Research Coordinator
ENCORE Research Group
01.2014 - 03.2019
- Certified Clinical Research Coordinator (CCRC)
- Cardiopulmonary Resuscitation (CPR)
- ICH Good Clinical Practice (GCP)
- International Air Transport Association (IATA)
- Human Gene Transfer Certification
- Basic Biosafety Certification
- NIH Recombinant DNA (rDNA) Guidelines certification
- Personal Training Certification through American Council on Exercise (ACE)
Bachelor of Science - Nutrition and Dietetics
Kent State University
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