Lydia J. Maru
CRA II
Summary
Accomplished Clinical Research Associate with over 10 years of experience in clinical trials and over 2 years performing and documenting pre-study site evaluations, regulatory document collection, interim monitoring and study close-out visits in multi therapeutic areas . Diligent in performing studies aligned with good clinical practices, study-specific requirements and clinical monitoring plans. In-depth knowledge of company procedures, regulatory requirements and quality standards.
Overview
17
17
years of professional experience
10
10
years of post-secondary education
3
3
Certifications
2
2
Languages
Work History
Clinical Research Associate (CRA) II
KEMRI-WELLCOME Trust
01.2022 - Current
- Monitor clinical trials to ensure compliance with in-country and global regulatory requirements and study protocols
- Conducted site selection, initiation, routine monitoring, and close-out visits for clinical trials in various therapeutic areas
- Formulation of risk assessment tools and monitoring plans to ensure trial objectives are met
- Monitor investigational product accountability, storage, and adherence to protocol
- Provides technical expertise and coordination oversight for projects in collaboration with relevant departments
- Perform source data verification, review essential documents, and maintain accurate study records
- Utilize various electronic data capture systems (RedCap, OpenClinica, KIDMIS, and iMedidata) to manage and analyze clinical trial data
- Coordinate with research teams to manage trial documentation, ethics submissions, and regulatory communications
- Mentor and Train Junior CRA
- Develop and deliver training for research staff at sites on study protocols and procedures
- Prepares, reviews, and coordinates local regulatory submissions (MoH, IRB/IEC) in a timely manner
- Collaborate with investigators and site staff to ensure protocol compliance, patient safety, and data integrity
- Prepare and support study teams for Audit and Inspections for the Ethics and Regulatory boards.
- Prepared and submitted monitoring reports, within the time frame identifying and resolving queries or deviations
- Participate in Protocol development review meetings and project team meetings
- Member of the Communication Consent Committee that develops specific Patient Information Sheet/Informed Consent form documents
- Studies: Phase 3 Chloroquine/hydroxychloroquine prevention of coronavirus diseases (COVID-19) in the healthcare setting a randomized placebo-controlled prophylaxis study. (COPCOV) 2 sites
- Phase 1 Trial of Repurposed Unithiol for snakebite Envenoming . (Safety Tolerability, Pharmacokinetics and Pharmacodynamics in healthy Kenyan Adults) (TRUE-1)
- A pragmatic Randomized Controlled trial of Standard care versus Steroids plus Standard Care for treatment in adults admitted to Kenyan hospital (SONIA) 11 sites
- VAC 074 (Safety, Immunogenicity, and efficacy of R21/Matrix- M and ChAd63/MVA-ME-TRAP in the context of controlled human malaria Infection: A Phase IIb Trial in Kenyan Adults)
- Phase 3 :Supportive Care and Antibiotics for Severe Pneumonia among Hospitalized Children (SEARCH): A Pragmatic Randomized Controlled Trial (16 sites)
- A Phase 1 Clinical Study to Evaluate the Safety and Immunogenicity of a Novel GMMA Vaccine Against Invasive Non-Typhoidal Salmonella in healthy Kenyan adults (SAVIS)
Study Coordinator/Research Study Nurse
KEMRI-WELLCOME TRUST
10.2016 - 12.2021
- Coordinated and managed Clinical Trials in various therapeutic areas focused on immunology and vaccinology
- Conducted participant recruitment, consent, and follow-up activities
- Ensured the accurate collection and entry of study data into electronic data capture systems
- Liaised with study sponsors, regulatory bodies, and other stakeholders to facilitate study progress
- Preparation and submission of trial documents to regulatory authorities, maintained and updated Investigator Site File
- Monitored patient safety and reported adverse events promptly
- Training of site staff on study procedures and protocol compliance
- Participated in study team meetings and provided input on study progress and challenges
- Administered investigational medicinal products
- Participated in stakeholder and community engagement with the community liaison group and outreach for clinical trials
- Coordinated all aspects of clinical monitoring and site management processes and coordinated with multidisciplinary teams for the success of clinical trials
- Conducted clinical assessments and collected biological samples from study participants
- Maintained detailed and accurate patient records in compliance with Good Clinical Practice (GCP) guidelines
- Educated participants and their families on study procedures, risks, and benefits
- Collaborated with multidisciplinary teams to ensure the smooth operation of clinical trials
- Achievements: Played a key role in achieving high patient enrollment and retention rates
Clinical Nurse
German Heart Centre Bremen-Dubai
01.2010 - 01.2013
- Assisted the Cardiologist in Cardiac procedures Stress tests, Echocardiography, Holter machines and BP machines and analyzed data thereafter
- Data collection for the main Dubai healthcare system (Hiras medical transcription) and ensuring clinic information is up to date by the end of the month
- Achievement: Assisted in Policy writing for the clinic for JCIA approval and Licensing
Ward Nurse
The City Hospital (Medi clinic)
01.2008 - 01.2009
- Admit and discharge of patients
- Assists the physician with the examinations and diagnostic procedures
- Assess and observe patients in my care and correctly document and act accordingly
- Providing nursing care for mothers in labor and postnatally
- Teach and counsel patients regarding good postnatal practices
Education
Post Graduate Diploma - Global Health Research
University of Oxford
Oxford 04.2023 - 12.2024
Bachelor of Science - Nursing
Pwani University
Kenya 01.2016 - 12.2019
Diploma - Community Health Nursing
St. Joseph's Nyabondo Medical Training College
01.2006 - 12.2007
Associate of Science - Nursing
Kenya Medical Training College
Thika, Nairobi Province, Kenya 04.1999 - 12.2001
Skills
Clinical research coordination
Completing regulatory documents and submissions
Patient safety and pharmocovigilance
Protocol training and adherence
Monitoring visits
Informed consent process
Project management and monitoring
Drug accountability
Quality control
Clinical data management
Certification
Nursing Council of Kenya, 03/01/24, 03/01/25, 415877 BSc.N (8845) KRCHN (9969) KECHN (19492)
Affiliations
Member, Nursing Council of Kenya
Training
- Research Methods, Kemri, 08/01/23
- Research Ethics Course, SARETI, 2023
- Certificate in Good Clinical Practice, 04/01/23
- Certificate in Research Ethics, 05/01/23
- Risk-based monitoring, Kemri-Wellcome Trust, 07/01/19, 10/01/22, 10/01/24
- Advance Certificate in Clinical Trial Operations, University of Addis Ababa, 04/01/22
- Certificate in Project Management, University of Washington, 09/01/19
Timeline
Post Graduate Diploma - Global Health Research
University of Oxford
04.2023 - 12.2024
Clinical Research Associate (CRA) II
KEMRI-WELLCOME Trust
01.2022 - Current
Study Coordinator/Research Study Nurse
KEMRI-WELLCOME TRUST
10.2016 - 12.2021
Bachelor of Science - Nursing
Pwani University
01.2016 - 12.2019
Clinical Nurse
German Heart Centre Bremen-Dubai
01.2010 - 01.2013
Ward Nurse
The City Hospital (Medi clinic)
01.2008 - 01.2009
Diploma - Community Health Nursing
St. Joseph's Nyabondo Medical Training College
01.2006 - 12.2007
Associate of Science - Nursing
Kenya Medical Training College
04.1999 - 12.2001