Role Overview
As a Clinical Research Associate (CRA) at Pharmaleaf, you will serve as the primary link between Pharmaleaf, trial sponsors, and clinical trial sites. You will conduct site qualification, initiation, routine monitoring, and close-out visits to verify that clinical trials adhere to protocol requirements, ICH-GCP guidelines, and applicable local regulations.
Key Challenges & Impact
Core Challenge Solved
Eliminating site monitoring backlogs, ensuring 100% Source Data Verification (SDV), and resolving site query backlogs while maintaining rigorous ICH-GCP protocol compliance.
Your vigilant oversight directly ensures participant safety and safeguards trial data integrity for biopharmaceutical sponsors conducting complex Phase II-IV global clinical programs.
Key Responsibilities
- Perform Pre-Study Visits (PSV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Study Close-Out Visits (COV).
- Conduct comprehensive Source Data Verification (SDV) and electronic Case Report Form (eCRF) data validation.
- Review investigational product (IP) accountability, storage conditions, and dispensing logs.
- Ensure complete regulatory binder documentation, IRB/IEC approvals, and informed consent forms (ICFs).
- Identify, report, and track adverse event (AE) and serious adverse event (SAE) reporting to PV safety teams.
- Generate timely monitoring trip reports and action-item tracking logs within 5 business days post-visit.
Qualifications & Requirements
- Bachelor's or Master's degree in Life Sciences, Biology, Pharmacology, Nursing, or related health discipline.
- 2+ years of independent clinical trial monitoring experience in Phase II-IV pharmaceutical or biotech trials.
- Strong mastery of ICH-GCP E6(R2) guidelines and FDA clinical trial regulations (21 CFR Parts 11, 50, 54, 56, 312).
- Experience using electronic data capture (EDC) systems (Medidata Rave, Veeva Vault, Oracle InForm).
- Willingness to travel (regional/national site travel up to 50-60%).