Erin Adek
Katy
Summary
Experienced clinical research professional with expertise in managing clinical trials and ensuring regulatory compliance. Skilled in project management, data analysis, and stakeholder engagement. Recognized for fostering collaboration, adapting to changing needs, and consistently delivering reliable results. Proficient in navigating complex protocols and driving successful completion of clinical studies.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Clinical Trial Manager
Parexel
10.2023 - Current
- Developed training materials for site staff to enhance their understanding of the study protocol, resulting in improved adherence to requirements.
- Managed cross-functional teams to ensure timely completion of clinical trial milestones and deliverables.
- Ensured compliance with regulatory guidelines by thoroughly reviewing protocols, informed consent forms, and other essential documents.
- Streamlined trial management processes for increased efficiency through diligent organization and coordination of resources.
- Led global Phase I–III clinical trials across multiple therapeutic areas and indications, ensuring adherence to study timelines and regulatory requirements.
- Managed study budgets, resources, and CRO/vendor partnerships, optimizing trial efficiency and cost-effectiveness.
- Served as the primary point of contact between sponsors, investigators, and regulatory authorities, ensuring smooth trial execution.
- Managed and mentored Clinical Research Associates (CRAs), ensuring proper site monitoring, adherence to study protocols, and issue resolution.
- Oversaw protocol development, site feasibility assessments, and study startup activities.
- Conducted risk assessments and implemented mitigation strategies to proactively address trial challenges.
- Led database lock and trial closeout activities.
Senior Clinical Research Associate (Lead CRA)
Parexel
04.2022 - 10.2023
- Conducted pre-study, initiation, routine monitoring, and closeout visits, ensuring adherence to ICH-GCP guidelines.
- Provided training and mentorship to junior CRAs on monitoring techniques, GCP compliance, and site management best practices.
- Performed source data verification (SDV) and collaborated with data management teams to ensure clean, high-quality data.
- Assisted in protocol feasibility assessments and site selection for global studies.
- Collaborated with cross-functional teams, including data management, regulatory affairs, and medical writing, to facilitate study progress.
- Led site management and monitoring activities across clinical trials.
- Provided oversight for audit and inspection readiness across multiple study sites.
- Communicated project status to management verbally and through technical documentation and presentations.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Managed project risk by identifying, quantifying and monitoring potential threats.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
Clinical Research Associate II
Parexel
08.2020 - 04.2022
- · Conducted on-site and remote monitoring for Phase I–III clinical trials, ensuring patient safety, protocol adherence, and regulatory compliance.
- · Performed site qualification, initiation, routine monitoring, and closeout visits to ensure site readiness and compliance with ICH-GCP, FDA, and sponsor requirements.
- Ensured source data verification (SDV) and timely resolution of data queries to maintain high-quality study data.
- Developed and maintained strong relationships with investigators, site staff, and key stakeholders to facilitate smooth study execution.
- Provided training and ongoing support to site staff on study protocols, GCP guidelines, and electronic data capture (EDC) systems.
- Monitored trials and ensured effective subject enrollment and site compliance.
- Ensured timely and accurate reporting of adverse events (AEs) and serious adverse events (SAEs).
- Prepared and submitted monitoring reports, documenting site performance and regulatory compliance.
Clinical Research Associate I
Parexel
01.2019 - 08.2020
- Assisted in the monitoring and management of clinical trial sites, ensuring compliance with GCP, protocol guidelines, and regulatory requirements.
- Supported site selection and feasibility assessments, coordinating investigator engagement and site initiation activities.
- Conducted on-site and remote monitoring visits, ensuring adherence to trial protocols, patient safety, and regulatory compliance.
- Collaborated with data management teams to ensure timely resolution of protocol deviations, queries, and missing data.
- Assisted with audit preparation, inspection readiness, and regulatory submissions, supporting high-quality study execution.
- Maintained detailed monitoring reports and documentation to ensure compliance and oversight.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Gained experience across multiple therapeutic areas.
Education
Bachelor of Arts - Philosophy
OAU
01-2006
Skills
- Adverse event reporting
- Clinical data management
- Training and mentoring
- Clinical Trial Oversight & Execution
- Regulatory Compliance (ICH-GCP, FDA, EMA)
- Protocol Development & Implementation
- Vendor & CRO Management
- Budget & Timeline Management
- Stakeholder Collaboration
- Electronic Data Capture (EDC) & CTMS
- Audit & Inspection Readiness
- End-to-End Clinical Trial Management
- Oncology, Neurology, Cardiovascular, Infectious & Rare Diseases
- Risk-Based Monitoring (RBM) & Risk Mitigation
- Site Selection, Initiation & Monitoring
- Clinical Data Review & Quality Oversight
Therapeutic Areas
- Oncology – DLBCL, CAR-T, Multiple Myeloma, Solid Tumors, CML, AML, Breast, Ovarian
- Neurology - Alzheimer’s disease, Parkinson’s disease, Epilepsy, Migraine
- Cardiovascular - Heart failure, Atrial fibrillation, Hypertension
- Infectious diseases - COVID-19, Hepatitis B, HIV
- Rare diseases - Muscular dystrophy, Cystic fibrosis
- Medical device – IVD, Continuous Glucose Monitoring Device
Certification
- GCP Certification
Affiliations
- Association of Clinical Research Professionals (ACRP)
Technical Skills
- EDC Systems (Medidata RAVE, Medrio, Oracle InForm)
- Clinical Trial Management Systems (CTMS)
- Risk-Based Monitoring (RBM)
- Microsoft Office Suite (Excel, Word, PowerPoint)
- Artificial Intelligence
Timeline
Clinical Trial Manager
Parexel
10.2023 - Current
Senior Clinical Research Associate (Lead CRA)
Parexel
04.2022 - 10.2023
Clinical Research Associate II
Parexel
08.2020 - 04.2022
Clinical Research Associate I
Parexel
01.2019 - 08.2020
Bachelor of Arts - Philosophy
OAU
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