Endiya Uko
Houston
Summary
Clinical research professional with expertise in managing complex clinical trials and ensuring regulatory compliance. Proven ability to foster collaborative team environments and drive successful project outcomes. Demonstrates reliability and adaptability with a strong focus on achieving results and maintaining high standards.
Overview
11
11
years of professional experience
Work History
Senior Clinical Research Associate
Marinus
08.2021 - Current
- Facilitated site selection and training of personnel on study protocols and procedures.
- Supervised monitoring activities of Clinical Research Associates, ensuring adequate training and accurate data collection.
- Conducted regular evaluations to assess site performance, address concerns, and ensure regulatory compliance.
- Collaborated with data management teams for timely, accurate data collection and reporting.
- Evaluated clinical trial data to identify patterns, inconsistencies, and potential risks.
- Enforced quality assurance protocols to maintain compliance with Good Clinical Practice and regulatory standards.
- Provided leadership and guidance to CRAs through training on study protocols and monitoring techniques.
- Acted as primary liaison between sponsor company, investigational sites, and contract research organizations.
Senior clinical research associate
Pharmaceutical Product Development (PPD)
02.2018 - 08.2021
- Managed study sites, conducting qualification, pre-study, initiation, routine, and close-out visits.
- Ensured data accuracy and compliance with GCP and regulatory standards.
- Guided site staff in protocol implementation and adverse event reporting.
- Streamlined operations through electronic systems including e-CRF, e-TMF, and CTMS.
- Formulated strategies and contingency plans to safeguard patient safety and data integrity.
- Handled adverse event oversight, ensuring timely reporting to sponsors and authorities.
- Provided training and mentorship to junior CRAs and site personnel for improved protocol adherence.
- Collaborated on corrective actions, maintaining FDA and ICH compliance.
Clinical Research Associate II
Pharmaceutical Product Development (PPD)
09.2015 - 02.2018
- 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.
CLINICAL RESEARCH ASSOCIATE I
Pharmaceutical Product Development (PPD)
08.2014 - 09.2015
- Prepared accurate, timely trip reports for efficient project tracking.
- Identified follow-up actions for SAES at assigned study sites and completed necessary tasks.
- Conducted independent CRF reviews, generating and resolving queries per established data guidelines.
- Confirmed study staff received proper materials, instructions, and training for protocol adherence.
- Verified informed consent procedures and protocol compliance to ensure subject protection.
- Ensured data integrity from CRFs and data collection tools through meticulous source document review.
Education
Bachelor of Science - Health Information Management
Colorado Technical University
Colorado Springs, COSkills
- Data management and reporting
- Site operations coordination
- Informed consent and compliance
- Adverse event monitoring
- Regulatory compliance
- Electronic data capture
- ICH-GCP proficiency
- Monitoring reports
- Problem-solving strategies
- Vendor management
- Therapeutic area knowledge
- Report writing skills
- Site monitoring expertise
Timeline
Senior Clinical Research Associate
Marinus
08.2021 - Current
Senior clinical research associate
Pharmaceutical Product Development (PPD)
02.2018 - 08.2021
Clinical Research Associate II
Pharmaceutical Product Development (PPD)
09.2015 - 02.2018
CLINICAL RESEARCH ASSOCIATE I
Pharmaceutical Product Development (PPD)
08.2014 - 09.2015
Bachelor of Science - Health Information Management
Colorado Technical University
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