Clinical Research Coordinator

Clinical Research Coordinator Overview

• The Clinical Research Coordinator role focuses on managing early-phase oncology trials with regional travel requirements.
• This contract position offers flexibility and potential for extension beyond six months.
• Collaborate with internal teams and site personnel to ensure study progress and compliance.
• Conduct site monitoring visits, including initiation, routine, and close-out visits.
• Verify adherence to protocol requirements and regulatory guidelines during monitoring activities.
• Prepare accurate monitoring reports and resolve data inconsistencies in clinical records.
• Participate in investigator meetings, protocol reviews, and development of study tools.
• Support SAE reporting and contribute to clinical study reports as required.

Clinical Research Coordinator Key Responsibilities & Duties

• Perform site management activities according to project plans and timelines.
• Ensure patient safety through verification of informed consent procedures and protocol adherence.
• Conduct thorough source document verification to ensure clinical data accuracy.
• Identify and resolve data discrepancies in CRFs or eCRFs during monitoring visits.
• Collaborate with internal teams, vendors, and site personnel to address operational issues.
• Participate in investigator meetings and contribute to protocol development and study tools.
• Manage SAE reporting, including narrative preparation and follow-up activities.
• Perform Quality Control Visits and independently resolve data queries in sponsor systems.

Clinical Research Coordinator Job Requirements

• Bachelor’s degree in life sciences, nursing, or related field preferred.
• Minimum 3 years of independent monitoring experience as a Clinical Research Associate.
• Strong understanding of ICH-GCP, clinical trial processes, and regulatory requirements.
• Experience with Phase I/II oncology trials is highly desirable.
• Proficiency with eCRF platforms, CTMS, eTMF, and standard office software.
• Valid driver’s license and ability to travel regionally up to 75%.
• Prior experience in early-phase clinical pharmacology or first-in-human studies preferred.
• Strong communication, problem-solving, and relationship-building skills.