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
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
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