Jamie R. Rittel
Evansville,IN
Summary
Accomplished Senior Clinical Research Associate with over 21 years of comprehensive experience in clinical research, including a strong foundation as a Lead Clinical Research Coordinator since 2005 and a Licensed Practical Nurse since 2001. Rapid advancement from Clinical Trial Assistant to CRA II within four months demonstrates adaptability and expertise. Proficient in a diverse array of therapeutic areas, including vaccine, pediatrics, infectious disease, neurodegenerative disease, dermatology, urology, rare disease, and general medicine. Extensive experience managing FDA audits at the site level and conducting internal audits across multiple projects ensures a commitment to regulatory compliance and quality assurance.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Independent Clinical Research Consultant
Compass Point Research
05.2025 - Current
- Trained new staff on clinical research practices and regulatory requirements.
- Implemented quality assurance measures to enhance research protocol adherence consistently.
- Resolved queries raised by sponsors or regulatory authorities related to study processes or outcomes.
Senior Clinical Research Associate
ICON Clinical Research
08.2022 - 05.2025
- Managed clinical trial operations, ensuring compliance with regulatory guidelines.
- Conducted site visits to evaluate performance and adherence to study protocols.
- Reviewed site regulatory binders for completeness and proper collection procedures.
- Completed unblinded monitoring visits to oversee investigational product management and accountability.
Senior Clinical Research Associate 2
Syneos Health
02.2021 - 08.2022
- Reviewed and monitored data collection for accuracy and completeness.
- Coordinated site selection and initiation for clinical research studies.
- Conducted site visits to assess trial progress and resolve issues.
- Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
- Completed unblinded monitoring visits to oversee investigational product management and accountability.
Senior Clinical Research Associate
IQVIA (formerly QuintilesIMS)
08.2019 - 02.2021
- Managed clinical trial operations and ensured compliance with regulatory guidelines.
- Performed pre-study, closeout and interim visits to check on study activities.
- Checked electronic data capturing systems for integrity and compliance.
Clinical Research Associate 2
Covance
08.2018 - 08.2019
- Adhered to good clinical practices, operating procedures and regulatory requirements.
- Checked electronic data capturing systems for integrity and compliance.
- Participated in internal audits related to clinical research operations processes.
Clinical Research Associate 2
IQVIA (formerly QuintilesIMS)
09.2016 - 08.2018
- Conducted site initiation visits and monitored ongoing studies at investigator sites.
- Adhered to good clinical practices, operating procedures and regulatory requirements.
- Identified experienced investigator through careful assessment to oversee conduct of trial at trial site.
Clinical Research Coordinator
Deaconess Clinic
03.2005 - 09.2015
- Coordinated clinical trial activities, ensuring compliance with regulatory requirements.
- Managed patient recruitment and informed consent processes for multiple studies.
- Conducted screening interviews to assess eligibility of potential subjects.
- Performed patient assessments, collected data, and prepared comprehensive reports.
- Took vital signs and gathered medical histories according to study protocols.
Education
LPN - Practical Nursing Program
Ivy Tech State College
Evansville, IN08.2001
Skills
- Good clinical practice
- Clinical trial management
- Investigator selection and site monitoring
- Quality assurance and regulatory compliance
- Risk assessment and mitigation
- Effective communication
- Problem solving and critical thinking
- Attention to detail
- Task prioritization
Certification
- Indiana Practical Nursing License, 27049725A, 2001
- Certified Clinical Research Coordinator, Association of Clinical Research Professionals, 2011
- ICH-GCP Accreditation, 2024
Clinical Research Associate Experience
- Phase 1-3, Vaccine-Flu, COVID, RSV and Acne, Sr. Clinical Research Associate, Full blinded and unblinded CRA responsibilities, Start up to Close-out
- Phase 1-2, Oncology - Multiple Myeloma, Malignant Solid Tumors, Sr. Clinical Research Associate II, Full CRA Interim Visit responsibilities
- Phase 2/3, Respiratory Syncytial Virus, Senior Clinical Research Associate, CRA responsibilities from Start-up to Interim visits
- Phase 3b, Type 2 Diabetes Mellitus with CV events, Clinical Research Associate II, CRA responsibilities from Interim visits to Close-out
- Phase 3, Alzheimer's Disease, Clinical Research Associate II, CRA blinded and unblinded responsibilities from Start-up to Close-out
- Phase 2, Non-Small Cell Lung Cancer, Clinical Research Associate II, Full unblinded CRA responsibilities from Interim visits to Close-out
- Phase 2, Crohn's Disease, Clinical Research Associate II, CRA responsibilities from Interim visits to Close-out
Study Coordinator Experience
Phase 1-4, NSCLC, Chemo-Induced Nausea, Metastatic Cancer, Osteoarthritis, Hypertensive Disorder, Hyperlipidemia, Depressive Disorder, Cardiovascular Disease, DM Type 2, Asthma, Psoriasis, Actinic Keratosis, Acne, Rosacea, Eczema, Onychomycosis, Atopic Dermatitis, Prostate Cancer, Cystitis, OAB, Bladder Cancer and BPH, Site CCRC, Study Coordinator Responsibilities from Start-up to Close-out
Clinical Trials Assistant Experience
Phase 3-4, Hemophilia, Metastatic Cancer, Clinical Trials Assistant, CTA Responsibilities from Start-up to Close-out
Timeline
Independent Clinical Research Consultant
Compass Point Research
05.2025 - Current
Senior Clinical Research Associate
ICON Clinical Research
08.2022 - 05.2025
Senior Clinical Research Associate 2
Syneos Health
02.2021 - 08.2022
Senior Clinical Research Associate
IQVIA (formerly QuintilesIMS)
08.2019 - 02.2021
Clinical Research Associate 2
Covance
08.2018 - 08.2019
Clinical Research Associate 2
IQVIA (formerly QuintilesIMS)
09.2016 - 08.2018
Clinical Research Coordinator
Deaconess Clinic
03.2005 - 09.2015
LPN - Practical Nursing Program
Ivy Tech State College
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