Key Responsibilities:
Assist in coordinating all aspects of clinical trial activities, including patient scheduling, follow-up, and communication
Obtain informed consent from study participants and provide education regarding study procedures
Collect and accurately document clinical data in source records and electronic data capture (EDC) systems.
Monitor and report patient safety data, including adverse events
Maintain organized and complete regulatory documentation and subject files
Assist with IRB submissions, amendments, and study start-up activities
Prepare for and participate in monitoring visits and sponsor audits coordinate the collection and process of blood or lab specimens in accordance with study protocols
Accurately enter patient and study data into electronic data capture (EDC) systems
Review and verify data from source documents to ensure completeness and accuracy
Organize, maintain, and update clinical trial files, logs, and documentation
Assist research staff with tracking visit schedules, reports, and study milestones
Respond to data queries from sponsors or monitors in a timely and professional manner
Support regulatory filings and assist in maintaining study binders and audit readiness
Collaborate with team members to ensure data is collected and entered within protocol-specified timelines
Requirements or Qualifications:
Degree or Diploma in Practical Nursing
1–2 years of experience in a healthcare or clinical research setting preferred
Familiarity with medical records and basic clinical documentation
Strong communication and organizational skills
Ability to multitask and work independently in a fast-paced environment
Basic understanding of Good Clinical Practice (GCP) and clinical research is a plus (training available) and good command over English language and willingness to work on US shifts