Job Title: Clinical Research Coordinator
Location: Remote
Employment Type: Full Time
Experience: 0–2 Years
Job Summary:
We are looking for a Clinical Research Coordinator to support clinical research studies and trial operations. The role involves study coordination, documentation, data management, patient/site support, and ensuring compliance with protocols and applicable regulations.
Key Responsibilities:
Support the day-to-day coordination and execution of clinical research studies and clinical trials.
Assist with study start-up activities, site activation, study initiation, and ongoing trial operations.
Coordinate day-to-day clinical study activities and support study start-up/site activation.
Maintain essential documents, study files, trackers, and clinical records.
Support patient recruitment, screening, scheduling, and follow-up activities.
Enter, review, and maintain clinical data in EDC/CTMS systems.
Assist with monitoring visits, audits, regulatory inspections, and study reporting.
Identify and document protocol deviations, data discrepancies, and study issues.
Ensure compliance with ICH-GCP, FDA regulations, SOPs, and study protocols.
Collaborate with Clinical Operations, Data Management, Safety, Quality, and Regulatory teams.
Participate in study meetings and follow up on assigned action items and timelines.
Escalate study-related risks, compliance concerns, data issues, and operational challenges to the appropriate team members.
Perform other clinical research and study coordination activities as assigned.
Required Skills:
Familiarity with clinical trial documentation, study protocols, informed consent, and essential study records.
Ability to work with clinical databases and systems such as EDC, CTMS, eTMF, or similar platforms.
Proficiency in Microsoft Office, particularly Word, Excel, PowerPoint, and Outlook.
Strong attention to detail and ability to maintain accurate documentation.
Good written and verbal communication skills.
Strong organizational and time-management skills with the ability to manage multiple priorities.
Ability to work effectively in a remote, cross-functional, and collaborative environment.