Edoe Nyajro
Houston,TX
Summary
High energy, detail-orientated Clinical Research Associate & Quality Assurance Auditor with a Barnett International certificate and 11 years experience in performing and documenting pre-study site evaluations, site initiation, regulatory document collection, interim monitoring and study close-out visits and performing sponsor audits. Knowledge about action planning, reviewing trends, diligent in performing study activities in accordance with good clinical practices, study-specific requirements, clinical monitoring plans, company procedures (SOPs), applicable regulatory requirements and defined quality standards. Clear communicator when working with internal teammates and stakeholders.
Overview
10
10
years of professional experience
Work History
Senior Clinical Research Associate
Spectral MD
2022.09 - Current
- Facilitate contract and budget negotiations with investigational sites and vendors.
- Collaborate with clinical operations and project management teams to identify potential investigational sites for clinical trials.
- Prepare, compile, and submit regulatory documents and applications required for the initiation of clinical trials.
- Conduct key site visits including site qualification, initiation, routine monitoring, and close‐out visits
- Patient recruitment and enrollment activities including tracking and coordinating enrollment number and reporting to internal team.
- Ensure site compliance with study protocols
- ·Develop and implement clinical strategies
- With the Clinical Team, responsible for establishing, managing, and meeting Clinical Trial milestones.
- Ensure adherence to GCP, ICH, and FDA regulations and guidelines
- Develop training, assessment tools, job aids for both SMD team and sites
- Prepare, track, and manage required study documentation and supplies. Presents this data to Clinical Team, Project Management, or other teams as needed and/or requested.
- Work extensively with sites and SMD to clean data and resolve urgent issues
- Liaise with Clinical Team, SMD personnel, and study site personnel to ensure timely and correct entry of data into eCRF, including the timely resolution of data queries
- Maintain credentialing requirements at hospitals and clinics as needed
Clinical Research & Quality Assurance Associate
GreenLight Clinical
2020.03 - 2022.05
- Monitor all QA processes contributing to the performance of the company.
- Conduct auditing activities to ensure that studies are conducted in accordance with client protocols, GCP, industry guidelines, agency regulations.
- Actively participate in activities in the areas of Internal Quality Audits, CAPA (Corrective and Preventive Actions), Quality Management Reviews, and Quality Audits.
- Conduct vendor audits and work with vendor personnel in eliminating problems via root cause analysis techniques. Review vendor supplied data and quality records for conformance and good documentation practices (GDP)
- Prepare and assist in preparing annual reports and quality trending reports.
- Contribute to QA continuous improvement programs and report the status of the quality levels of staff and systems to the Manager, QA. Communicate any critical compliance risks noted from activities to senior management.
- Performed clinical trial site evaluation, initiation (SIVs), routine monitoring (IMVs) and closeout visits (COVs).
- Reviewed and ensured Investigator Site File (ISF)/ (eISF) are up to date and collected essential documents for the Trial Master File (eTMF).
- Ensured proper handling, accountability and reconciliation of all Investigational products and clinical trial supplies.
- Prepared and submit trip reports/ monitoring visit reports according to project timelines.
- Oversaw and supported sites with subject recruitment and retention strategies.
- Interacted directly with sites, including clinical investigators (PIs) and other health care professionals involved in the clinical trial to maintain a positive rapport and ensure project expectations are met.
Clinical Quality Assurance Auditor
RCTS
2019.01 - 2020.02
- The Quality Assurance Lead oversees quality assurance functions for the organization including, but not limited to development and maintenance of quality assurance programs and policies, oversight of inspections and audits, and management of Quality Documents
- Maintaining a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols
- Developing, implementing, and maintaining an internal audit monitoring system and schedule
- Leading the ongoing development, management, and implementation of written processes for effectively managing clinical trials
- Leading the reporting of trends and metrics from all clinical activities to aid in effective process
- Maintaining Standard Operating Procedures (SOPs) including periodic review and coordination of the initiation/revision of procedures and policies to ensure compliance with new/revised regulations and guidelines
- Ensuring quality incidents are investigated, root cause analysis is performed, and CAPA has been implemented and monitored for effectiveness
- Partnering with study teams to identify potential changes and opportunities for process improvement
- Evaluating responses to monitoring and audit reports with the research team; follow-up with applicable stakeholders to ensure resolution
Clinical Research Associate
Novum Pharmaceutical Service
2017.11 - 2019.01
- Performed clinical trial site evaluation, initiation (SIVs), routine monitoring (IMVs) and closeout visits (COVs).
- Reviewed and ensured Investigator Site File (ISF)/ (eISF) are up to date and collected essential documents for the Trial Master File (eTMF).
- Ensured proper handling, accountability and reconciliation of all Investigational products and clinical trial supplies.
- Prepared and submit trip reports/ monitoring visit reports according to project timelines.
- Oversaw and supported sites with subject recruitment and retention strategies.
- Interacted directly with sites, including clinical investigators (PIs) and other health care professionals involved in the clinical trial to maintain a positive rapport and ensure project expectations are met.
Clinical Research Coordinator
Novum Pharmaceutical Research Service
2015.09 - 2017.11
- Participated and assisted in initiation, monitoring and closeout visits at research sites in compliance with the approved protocols.
- Maintained accurate and complete records, including regulatory documents, signed informed consent forms, source documentation, drug dispensation logs, screening and enrollment logs, and study communications.
- Patient recruitment and pre-screening.
- Schedule subjects for appointments, procedure, or inpatient stays as required by study protocols.
- Dispense drugs and calculate dosages and provide instructions as necessary.
Quality Control Associate
Novum Pharmaceutical Research Service
2014.07 - 2015.09
- Review all patient source data to identify errors and inconsistencies. Performing internal source data verification (SDVs) and source data reviews (SDRs)
- Work with our Research Team to ensure excellent quality of all patient data by providing trends and eduction on ALCOA-C.
- Internal query resolution.
- Follow all ICH/GCP and FDA Regulations with regards to Clinical Research.
- Ensure all deviations and documentation errors are sent to clinical staff for correction and updates as well as reportable events (AEs, SAEs and SUSARs as applicable.
Education
Bachelor of Science - Cell And Molecular Biology
Louisiana State University At Shreveport
Shreveport, LA05.2014
Skills
- Excellent communication, both written and verbal, and interpersonal skills.
- Detail orientated.
- Multi-tasker.
- Great presentation skills.
- Adaptability to changing requirements.
- Critical thinker.
- Documentation and report writing skills.
- Organization skills.
Timeline
Senior Clinical Research Associate
Spectral MD
2022.09 - Current
Clinical Research & Quality Assurance Associate
GreenLight Clinical
2020.03 - 2022.05
Clinical Quality Assurance Auditor
RCTS
2019.01 - 2020.02
Clinical Research Associate
Novum Pharmaceutical Service
2017.11 - 2019.01
Clinical Research Coordinator
Novum Pharmaceutical Research Service
2015.09 - 2017.11
Quality Control Associate
Novum Pharmaceutical Research Service
2014.07 - 2015.09
Bachelor of Science - Cell And Molecular Biology
Louisiana State University At Shreveport
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