RICHARD JUMA OTWO
Berlin
Kurzprofil
Clinical Research Coordinator and Study Nurse with over one year of experience supporting international Phase II–IV clinical trials. Experienced in ICH-GCP-compliant study coordination, monitoring readiness, regulatory documentation, investigational product accountability, source documentation, eCRF management, and collaboration with investigators, sponsors and CROs. Supported more than 20 monitoring visits without critical GCP findings and maintained 100% protocol-compliant IMP accountability. Seeking to transition into Medpace's Entry-Level CRA role through the PACE Training Program.
Übersicht
3
3
Languages
1
1
Certification
2
2
years of professional experience
Berufserfahrung
Clinical Study Coordinator / Study Nurse
Gastroenterology Research Centre
Berlin
2025.05 - 2026.08
- Coordinate Phase II–IV IBD clinical trials.
- Prepare studies for monitoring visits, audits and sponsor reviews.
- Maintain inspection-ready ISF and essential documents.
- Manage IMP accountability using IRT/IWRS.
- Perform informed consent, ECGs, blood draws, vital signs and sample processing.
- Resolve eCRF queries and maintain accurate source documentation.
- Collaborate with investigators, CRAs, sponsors and CROs.
- Achievement: Supported 20+ monitoring visits with no critical GCP findings.
- Achievement: 100% protocol-compliant IMP accountability.
Clinical Research Nurse
ISA Research GmbH
2024.09 - 2025.01
- Supported Phase II–III clinical trials.
- Prepared monitoring visits.
- Maintained GCP-compliant documentation.
CRA Training
PharmaAkademie
2024.02 - 2024.06
- Training in Risk-Based Monitoring, SDV, GCP, TMF and monitoring reports.
Ausbildung
BSc (Hons) - Health Sciences (Health Systems Development)
Catholic University of Eastern Africa (CUEA)
Nairobi,Kenya 2014 - 2017.01
Higher National Diploma - Nursing (Community Health & HIV/AIDS )Care
Kenya Medical Training College
Nairobi,Kenya 2015 - 2016.01
Diploma - Pharmacy (Pharmaceutical Technology)
Kenya Medical Training College
Nairobi,Kenya 2005 - 2008.01
Kompetenzen
- Phase II–IV clinical trials Management
- ICH-GCP compliance
- Monitoring visit support
- ISF management
- Source documentation & eCRF (RAVE)
- AE/SAE documentation support
- IMP accountability (IRT/IWRS)
- Patient recruitment
- ECG Interpretation
- Phlebotomy
- Sample processing (Blood, Urine, Biopsies)
- Regulatory compliance
- Pharmacovigilance
- Systems:- Medidata RAVE,REDCap,Clario,Labcorp(Xellerate),Alimentiv,IRT/IWRS,MS Office
Languages
English
Proficient
C2
German
Upper intermediate
B2
Swahili
Advanced
C1
Further Studies (Apprenticeship)
CRA Training, PharmaAkademie, 02/01/24, 06/30/24, Training in Risk-Based Monitoring, SDV, GCP, TMF and monitoring reports.
Zertifizierung
- IATA certified
- ICH GCP (R3) certified
- Phlebotomy certified
- Pharmacy Technologist Licence
Zeitleiste
Clinical Study Coordinator / Study Nurse
Gastroenterology Research Centre
2025.05 - 2026.08
Clinical Research Nurse
ISA Research GmbH
2024.09 - 2025.01
CRA Training
PharmaAkademie
2024.02 - 2024.06
Diploma - Pharmacy (Pharmaceutical Technology)
Kenya Medical Training College
2005 - 2008.01
Higher National Diploma - Nursing (Community Health & HIV/AIDS )Care
Kenya Medical Training College
2015 - 2016.01
BSc (Hons) - Health Sciences (Health Systems Development)
Catholic University of Eastern Africa (CUEA)
2014 - 2017.01