Madelein Kruger
Pretoria
Summary
Results-driven Senior Clinical Research Associate with 18 years of experience in monitoring clinical trials and ensuring compliance with GCP and regulatory standards. Expertise in Phase I-IV trials, particularly in oncology and immunology, alongside strong skills in site management and data integrity. Experienced in cross-functional collaboration and implementing effective patient recruitment strategies to enhance trial outcomes.
Overview
35
35
years of professional experience
1
1
Certification
Work History
Senior Clinical Research Associate/Project Manager
Experienced Independent Contractor
Pretoria
01.2025 - Current
- Conducted clinical monitoring activities including site qualifications and initiation visits as per standard operating procedures.
- Monitored trial progress, identifying and addressing issues promptly to stay on schedule and within budget.
- Identified site issues and risks, developed solutions, and escalated concerns to maintain trial integrity.
- Maintained communication with study sites and stakeholders to ensure alignment throughout the study process.
- Prepared for audits by ensuring data integrity and documentation quality throughout the study lifecycle.
- Collaborated with clinical trial managers and other teams to support project objectives.
- Maintained communication with patients, carers and professionals to support high-quality service delivery.
- Recruited and screened participants, ensuring eligibility criteria were met for reliable and valid data collection.
- Designed and implemented clinical research protocols to meet study objectives, adhering to ethical standards.
- Conducted risk assessments for study protocols, minimising hazards and enhancing participant safety.
- Monitored clinical trial progress using internal systems such as CTMS and EDC platforms.
- Reviewed regulatory documents to ensure accurate maintenance of investigator site files.
- Conducted regular site visits, audits, and reviews to verify adherence to clinical research guidelines.
- Implemented risk management strategies to mitigate potential trial delays and challenges.
- Negotiated study budgets and contracts with trial sites, ensuring financial efficiency.
- Supported data collection and verification to ensure adherence to study timelines and objectives.
- Managed patient follow-up, maintaining engagement and adherence to study protocols for robust outcomes.
- Administered questionnaires and conducted interviews, collecting high-quality data for analysis and interpretation.
- Coordinated with regulatory bodies, submitting required documentation for audits and inspections.
- Set up, cleaned and maintained laboratory equipment for optimal use and accurate results.
- Coordinated sample retrieval and processing, documenting data in alignment with laboratory protocols.
- Monitored data to verify accurate file documentation and storage in accordance with regulatory requirements.
- Managed data entry and database maintenance, guaranteeing accuracy and security of participant information.
- Attended meetings with project lead to obtain understanding of key project requirements and priorities.
- Reviewed and updated standard operating procedures, ensuring practices reflected current regulations and guidelines.
- Provided mentorship to junior researchers, guiding their professional development and enhancing team capabilities.
- Liaised with investigators and healthcare professionals to foster strong site relationships.
- Contributed to drafting of grant applications to secure funding for continued research.
- Negotiated study budgets and contracts with trial sites, ensuring financial efficiency.
- Conducted regular site visits, audits, and reviews to verify adherence to clinical research guidelines.
Senior Clinical Research Associate
ICON International
Pretoria
08.2022 - 12.2024
- Oversaw the monitoring of all types of clinical trials, ensuring adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures.
- Enhanced communication among team members and site staff to streamline collaboration and resolve issues effectively.
- Informed project leadership of team issues, seeking guidance.
- Engaged in Business Development client presentations and bid defences when requested.
- Guaranteed compliance with CFR, state regulations, ICH, GCP guidelines, and ICON/Novartis sponsor SOPs.
- Maintained up-to-date regulatory documentation according to Essential Regulatory Document Guidelines (ERDG) and Trial Master File (TMF) Plan.
- Conducted TMF and on-site audits as required.
- Assumed responsibility for site management and site staff performance.
- Conducted oversight of various clinical trial types to ensure compliance with protocols.
- Performed site visits to assess compliance and operational efficiency at clinical sites.
- Monitored Principal Investigator activities to uphold integrity and compliance with study standards.
- Maintained compliance with all protocol requirements.
- Developed effective patient identification and recruitment plans.
- Ensured timely reporting of Adverse Events (AEs)/Serious Adverse Events (SAEs) and protocol violations.
- Conducted regular Investigational Product (IP) accountability.
- Reviewed the status of the contents of the site Regulatory Binder periodically.
- Conducted training visits for less experienced CRAs to support their development and ensure compliance with monitoring standards.
- Participated in assessments of less experienced CRAs for sign-off visits after obtaining manager approval and completing required training.
- Conducted source document verification (SDV) according to contractual requirements.
- Guaranteed the timely completion and submission of Case Report Forms (CRFs) according to Clinical Monitoring Plan or Data Management Plan (DMP).
- Ensured accurate and timely completion of Data Clarification Forms (DCFs).
- Reviewed clinical data listings as needed.
- Compiled and submitted visit trip reports adhering to SOP requirements, necessitating minimal revisions.
- Maintained awareness of critical study performance indicators for own sites, e.g., patient enrolment and SAEs.
- Updated study and patient status information, serving as a CTMS resource for PM/LCRA.
- Oversaw investigator payments and milestones to ensure timely processing and adherence to project timelines.
- Documented and monitored the resolution of all outstanding site-specific protocol-related issues during visits.
- Assisted with the preparation and attendance of investigator meetings when requested, may present as needed.
- Aided in the preparation of study start-up materials and tools upon request.
- Participated in clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to project communication, monitoring, and/or training plans.
- May have assumed Clinical Team Lead/Lead CRA role and/or assisted with LCRA activities such as tool development, study plans, and team training.
- Performed additional work-related duties as assigned.
- Demonstrated extensive understanding of SOPs, WI, FDA and local regulations alongside ICH guidelines.
- Willing to travel domestically and internationally (more than 50%) when required.
Clinical Research Associate ll
Syneos Health
Home
01.2016 - 07.2022
- Directed the monitoring of all types of clinical trials, ensuring adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures. Served in a Lead CRA capacity.
- Facilitated timely communication among team members and site staff, enhancing collaboration and project alignment.
- Informed project leadership of team issues and sought guidance when needed.
- Engaged in Business Development client presentations and bid defences as requested.
- Ensured compliance with CFR, State regulations, ICH, and GCP guidelines, as well as Syneos Health and sponsor SOPs.
- Sustained current regulatory documentation following Essential Regulatory Document Guidelines (ERDG) and the Trial Master File (TMF) Plan.
- Engaged in TMF and on-site audits as required.
- Managed site operations and monitored staff performance to ensure compliance.
- Monitored diverse types of clinical trials.
- Engaged in all types of site visits effectively.
- Ensured Principal Investigator (PI) integrity.
- Maintained compliance with all protocol requirements.
- Developed and executed effective patient identification and recruitment plans.
- Guaranteed timely reporting of AEs/SAEs and protocol violations, ensuring compliance and patient safety.
- Conducted regular Investigational Product (IP) accountability.
- Reviewed the status of the contents of the site Regulatory Binder routinely.
- Executed training visits with less experienced CRAs.
- Engaged in assessing less experienced CRAs for sign-off visits following manager approval and after completion of required training.
- Performed source document verification (SDV) aligned with contractual obligations.
- Ensured timely completion and submission of CRFs as per the Clinical Monitoring Plan (CMP) and/or Data Management Plan (DMP).
- Guaranteed prompt and precise completion of Data Clarification Forms (DCFs).
- Conducted reviews of clinical data listings as necessary.
- Compiled and submitted visit trip reports in accordance with SOP requirements, requiring minimal revisions.
- Maintained vigilance over key study performance indicators for assigned sites, e.g., patient enrolment and SAEs.
- Updated study and patient status information, serving as a CTMS resource for PM/LCRA.
- Monitored investigator payments and tracked milestones for accurate record-keeping.
- Documented and monitored the resolution of all outstanding site-specific protocol-related issues throughout visits.
- Assisted with the preparation and attended investigator meetings as requested, potentially presenting when required.
- Aided in preparing study start-up materials and tools when requested.
- Attended clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions, as outlined by the project communication, monitoring, and/or training plans.
- May have taken on Clinical Team Lead/Lead CRA roles and/or assisted with LCRA activities, including tool development, study plans, and team training.
- Performed additional tasks related to clinical trials as required by the team.
- Demonstrated extensive comprehension of SOPs, WI, FDA and local regulations alongside ICH guidelines.
- Willing to travel domestically and internationally (more than 50%) as required.
- Worked at INC Research, contributing to clinical trial management.
- Monitored patient safety, reported adverse events, and ensured appropriate follow-up actions were taken.
- Conducted reviews to verify the accuracy of collected clinical trial data and reported discrepancies.
- Conducted qualification, initiation and monitoring visits to assess site performance and achieve agreed protocol standards.
- Progressed projects to deadlines by monitoring submissions, managing recruitment and confirming case report form completion.
- Gathered documents for ethical and administrative submissions, checking information accuracy before completion.
- Observed study completion and delivery, evaluating complicity for reliable outcomes.
- Compiled and delivered study progress reports in internal and external meetings, providing stakeholders with critical insights on trial status.
- Conducted site visits to monitor compliance with protocol and overall clinical trial performance.
- Maintained internal systems with study site data for continued performance and progress tracking.
- Collaborated with cross-functional teams to ensure seamless execution of clinical trials.
Clinical Research Associate ll
Clintec International
Home
01.2015 - 12.2015
- Executed clinical on-site monitoring activities, including driving patient recruitment, source data verification, drug accountability, and data collection, while collecting regulatory documentation as required and performing qualification, initiation, monitoring, and termination of investigational sites in accordance with ICH GCP guidelines.
- Met CRA I requirements with proficiency and autonomy, contributing to successful project execution.
- Exhibited a solid understanding of therapeutic indications and study hypotheses.
- Functioned as a mentor and role model to other CRA team members to ensure study-specific training.
- Monitored patient safety on-site by reviewing for any missing SAEs, AEs, and concomitant medications, and addressing protocol violations accordingly.
- Conducted co-monitoring visits alongside less experienced CRAs or at problematic sites as necessary.
- Built and maintained relationships with investigators and site staff, fostering collaboration and effective communication.
- Participated in investigator and other internal or external meetings as required.
- Coordinated on-site visits and logistics, including travel arrangements.
- Conducted on-site visits in line with the monitoring plan.
- Facilitated on-site study-specific training when applicable.
- Performed inspections of site facilities.
- Monitored and upheld ICH-GCP compliance.
- Held responsibility for the completeness and quality of on-site files.
- Responded to site issues raised by the project team (e.g. non-responsive site, protocol deviations, quality concerns) that necessitated face-to-face interaction.
- Collected Statutory Regulatory Package documents during Qualification Visits and other visits.
- Established a site recruitment plan in collaboration with the site during Qualification Visits and followed up on updates during Initiation and Monitoring Visits.
- Updated all relevant tracking systems continuously.
- Collaborated with Clinical Management Associates (CMA) on site issues and actions.
- Generated visit/contact reports in accordance with the monitoring plan.
- Escalated all issues requiring immediate action to the Project Leader.
- Encoded and scanned Central File documents where applicable.
- Shipped relevant signed documents back to the Assistant or the site.
- Participated in audits or Regulatory Inspections if requested.
- Completed all routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel, expense reports).
- Acted as an independent CRA Coordinator on complex or multiple projects, and as a CRA Coordinator on smaller projects.
- Recognised out-of-scope activities and communicated them to the Study Team.
- Represented the function in external client meetings and presentations, including investigator meetings and bid defences when required.
- Assumed responsibility for specific project tasks or served as the main CRA contact on individual projects.
- Provided feedback in the formal staff review process in conjunction with Line Management.
- Monitored patient safety by reporting adverse events and ensuring timely follow-up actions, safeguarding participant welfare.
- Reviewed and verified accuracy of clinical trial data collected, identifying and reporting discrepancies.
- Conducted qualification, initiation and monitoring visits to assess site performance and achieve agreed protocol standards.
- Progressed projects to deadlines by monitoring submissions, managing recruitment and confirming case report form completion.
- Observed study completion and delivery, evaluating complicity for reliable outcomes.
- Gathered documents for ethical and administrative submissions, checking information accuracy before completion.
Clinical Research Associate l
Parexel International
Pretoria
05.2013 - 12.2014
- Oversaw all aspects of study site monitoring, including routine monitoring and close-out of clinical sites, maintaining study files, and conducting pre-study and initiation visits.
- Executed administrative and monitoring responsibilities for clinical studies in accordance with Covance Standard Operating Procedures, ICH Guidelines, and GCP.
- Monitored patient safety, reported adverse events, and ensured appropriate follow-up actions were taken.
- Managed the reporting of Serious Adverse Events (SAEs) and facilitated the processing of necessary reports.
- Conducted site visits to monitor compliance with protocol and overall clinical trial performance.
- Reviewed and verified accuracy of clinical trial data collected, identifying and reporting discrepancies.
- Collaborated with cross-functional teams to ensure seamless execution of clinical trials.
- Trained, mentored, and developed junior employees through co-monitoring, enhancing team capability and knowledge transfer.
- Recruited potential investigators, prepared ethics committee submissions, translated study-related documentation, and organised meetings to support study initiation and compliance.
- Negotiated study budgets with prospective investigators and assisted the Covance legal department with statements of agreements as assigned.
- Prepared and presented study progress reports during internal and external meetings.
- Maintained internal systems with study site data to ensure accurate tracking of study performance and progress.
- Collaborated with internal workgroups to evaluate needs, resources, and timelines.
- Ran site risk assessments regularly, adapting monitoring levels to suit varying study stages.
Senior Clinical Research Coordinator / Site Manager
Dey clinic
Pretoria
01.2007 - 04.2013
- Deep understanding of clinical research regulations (ICH-GCP, FDA, EMA).
- Exceptional written and verbal communication, interpersonal, and problem-solving skills.
- Strong ability to monitor multiple sites, manage time effectively, and prioritize tasks.
- Submitted regulatory documents to the IRB and Sponsor.
- Facilitated the clinical study agreement submission to OSP for review.
- Participated in investigator meetings to discuss study updates and strategies.
- Developed preliminary budgets, verifying all costs associated.
- Assisted the Principal Investigator in negotiating the study budget direct costs with the sponsor to cover all expenses (F&A costs are not negotiable).
- Prepared for study initiation by obtaining necessary physician signatures.
- Recruited study subjects and scheduled screening appointments, ensuring informed consent was obtained.
- Educated subjects on protocol expectations and procedures.
- Executed study/protocol procedures with attention to detail, ensuring adherence to regulatory standards.
- Maintained comprehensive study files to support regulatory compliance and study integrity.
- Administered study budget and payments, ensuring timely invoicing to sponsor for completed work.
- Monitored subject status to prevent loss to follow-up.
- Documented adverse events, detailing the event, severity, frequency, treatment, and resolution.
- Processed laboratory samples and shipped them to designated facilities for analysis.
- Filled out case report forms (CRFs) for review and approval by the Principal Investigator.
- Assisted study monitors with CRA corrections as required.
- Managed and maintained study-specific supplies.
- Prepared for study closure and ensured proper archiving of documentation.
- Proficient in MS Office, EDC systems, CTMS platforms, and remote monitoring tools.
- Traveled up to 50% domestically and internationally to meet project requirements.
- Supervised a team of subcontractors and workers, promoting a culture of safety and productivity on site.
- Developed strong relationships with clients, building trust and facilitating smooth project execution.
- Managed site logistics efficiently, ensuring equipment and materials were available as required.
- Conducted risk assessments to proactively address potential hazards on construction sites.
- Conducted regular site inspections to identify and rectify potential issues promptly.
- Completed projects on time and within allocated budget.
- Implemented quality control procedures to uphold high standards of construction and finish.
- Inspected sites for compliance with established rules and regulations to avoid accidents or incidents.
- Maintained compliance with health and safety regulations, reducing risk of on-site incidents.
- Ensured daily communication with vendors to monitor project progress.
- Coordinated employee schedules and tasks to match workloads, adjusting team sizes and assignments with changing needs.
- Managed construction site operations, overseeing project progress and maintaining schedules to meet deadlines.
- Liaised with suppliers to secure timely delivery of materials, preventing project delays.
- Delivered training sessions on safety protocols, enhancing team awareness and competence.
- Resolved conflicts among team members, maintaining a positive and collaborative work environment.
- Directed project activities to meet client's requirements by assessing progress and instituting measures to drive task completion.
- Kept project delivery on schedule by establishing benchmarks, assigning budgets and observing progress.
Senior Flight Attendant
South African Arilines
Johannesburg
01.1997 - 12.2006
Profesional Nurse specialized in Theatre
Eugene Marais Hospital
Pretoria, Gauteng
01.1991 - 12.1996
Education
National Diploma - General Nursing and Theatre
Eugene Marias Hospital Nursing College
Pretoria, South Africa01-1995
Skills
- Clinical trial management
- Clinical Monitoring
- Site monitoring
- Clinical study oversight
- Clinical data management
- Data Collection
- Data management
- Data entry and management
- Risk assessment
- Risk Management
- Regulatory Compliance
- Regulatory compliance
- GCP
- ICH guidelines understanding
- FDA
- Informed consent process
- Adverse event reporting
- Quality Assurance
- Quality control
- Quality control adherence
- Quality Control Analysis
- CTMS platforms
- EDC systems
- Project Management
- Project coordination
- Budget negotiation
- Therapeutic area knowledge
- Therapeutic protocol knowledge
- Patient recruitment
- Recruitment strategies
- Trial monitoring
- Communication
- Effective communication
- Clear communication
- Interpersonal
- Interpersonal communication
- Team collaboration
- Team work
- Team Leadership
- Mentorship capability
- Problem-solving
- Problem solving
- Decision making
- Critical-thinking
- Analytical-thinking
- Data analysis
- Time Management
- Time-management
- Time efficiency
- Prioritization
- Accountability
- Independent worker
- Communication skills
- Active listening
- Strategic planning
- Strategic thinking
- Report writing
- Haematology
- Accountability
- Interpersonal communication
- Quality Assurance
- Strategic thinking
- Data analysis
- Analytical-thinking
- Quality Control Analysis
- Report writing
Certification
- South Africa Nursing Council (SANC) registered, Boksburg Hospital Nursing College
- General Nursing and Theatre Diploma, Boksburg Hospital Nursing College
- American Heart Association BLS Program, Emergency Medical Training
- Flight Attendant South African CAA License (Domestic and International), Trainer Course in Aviagen Medicine
- Certified Clinical Research Professional (CCRP), Clinical Research
Languages
English
Afrikaans
Websites, Portfolios and Profiles
https://www.linkedin.com/in/madelein-kruger42834867/
Timeline
Senior Clinical Research Associate/Project Manager
Experienced Independent Contractor
01.2025 - Current
Senior Clinical Research Associate
ICON International
08.2022 - 12.2024
Clinical Research Associate ll
Syneos Health
01.2016 - 07.2022
Clinical Research Associate ll
Clintec International
01.2015 - 12.2015
Clinical Research Associate l
Parexel International
05.2013 - 12.2014
Senior Clinical Research Coordinator / Site Manager
Dey clinic
01.2007 - 04.2013
Senior Flight Attendant
South African Arilines
01.1997 - 12.2006
Profesional Nurse specialized in Theatre
Eugene Marais Hospital
01.1991 - 12.1996
National Diploma - General Nursing and Theatre
Eugene Marias Hospital Nursing College