Jennifer Adams

• Phone: +1 416 555 0123
• Email: jennifer.adams@email.com
• Location: Toronto, Canada
• LinkedIn: jennifer-adams-crc

Summary

Four years of experience in clinical trial management, successfully coordinating over 15 Phase I-III studies across oncology and cardiology therapeutic areas. Proficient in ICH-GCP guidelines, regulatory submissions, and electronic data capture systems, ensuring high-quality data integrity and participant safety.

Adept at patient recruitment, informed consent processes, and meticulous documentation, contributing to timely study milestones and adherence to protocol requirements.

Experience

Clinical Research Coordinator, Mount Sinai Hospital -- Toronto, Canada

Jan 2021 – present

• Managed and coordinated 8 active clinical trials (Phase II-III) in oncology, overseeing patient recruitment, scheduling, and follow-up for over 100 participants.

• Ensured 100% compliance with ICH-GCP guidelines, institutional policies, and study protocols, resulting in zero major findings during sponsor audits.

• Prepared and submitted regulatory documents to REB/IRB and Health Canada, facilitating timely study approvals and amendments.

• Maintained accurate and complete source documents and electronic case report forms (eCRFs), achieving a data query resolution rate of 98% within specified timelines.

• Conducted informed consent discussions and patient education, ensuring comprehensive understanding of study procedures and potential risks.

Junior Clinical Research Coordinator, Toronto General Hospital -- Toronto, Canada

June 2019 – Dec 2020

• Assisted in the coordination of 7 Phase I-II cardiology clinical trials, supporting patient screening, enrollment, and data collection activities.

• Performed vital sign measurements, ECGs, and sample collection according to study protocols, ensuring accuracy and proper handling.

• Organized and maintained study binders, participant files, and regulatory documents, ensuring audit-readiness at all times.

• Scheduled and coordinated monitoring visits, interacting with CRAs and responding to data queries efficiently.

• Provided administrative support for research team meetings, including agenda preparation and minute taking.

Education

University of Toronto, MSc in Master of Science in Clinical Research -- Toronto, Canada

Sept 2017 – May 2019

McMaster University, BHSc in Bachelor of Health Sciences -- Hamilton, Canada

Sept 2013 – Apr 2017

Skills

Clinical Research Management: ICH-GCP, Regulatory Submissions (REB/IRB, Health Canada), Clinical Trial Protocol Adherence, Informed Consent Process, Patient Recruitment & Retention, Source Documentation, eCRF Data Entry, Data Query Resolution, Adverse Event Reporting, SAE Management, Study Close-out Procedures

Technical Skills: EDC Systems (Medidata Rave, Oracle Clinical), CTMS (Clinical Trial Management Systems), Microsoft Office Suite (Word, Excel, PowerPoint, Outlook), Electronic Health Records (Epic, Cerner), Lab Information Systems

Therapeutic Areas: Oncology, Cardiology, Rare Diseases, Immunology

Regulatory & Compliance: Health Canada Regulations, FDA Regulations (21 CFR Part 11), Privacy Regulations (PHIPA, HIPAA), Ethics Committee Submissions