What are the responsibilities and job description for the Senior Clinical Research Coordinator position at X4 Life Sciences?
We are seeking a highly skilled and experienced Senior Clinical Research Coordinator to join our expanding research team in Pennsylvania. The ideal candidate will bring advanced expertise in clinical trial coordination, regulatory compliance, and patient management, as well as leadership in supporting junior staff and contributing to study planning and execution.
Key Responsibilities:
- Lead and oversee the coordination of multiple clinical trials in compliance with FDA regulations, ICH-GCP guidelines, and institutional policies.
- Serve as the primary point of contact for sponsors, monitors, and regulatory bodies.
- Obtain and document informed consent from study participants in accordance with ethical and regulatory standards.
- Perform and oversee clinical procedures, including phlebotomy, vital signs, ECGs, and specimen handling per study protocols.
- Review, interpret, and manage laboratory results, ECGs, and other clinical data, ensuring timely investigator review and follow-up.
- Identify, document, and report Adverse Events (AEs) and Serious Adverse Events (SAEs) promptly to the Principal Investigator and sponsor.
- Coordinate and manage patient scheduling, ensuring visits occur within protocol-specified windows.
- Dispense investigational products per protocol, provide medication education, and monitor subject compliance and progress.
- Assist in protocol development, staff training, and mentoring junior CRCs to ensure operational excellence across studies.
Requirements:
- 2-5 years of experience as a Clinical Research Coordinator in an r clinical research setting.
- Strong background in FDA-regulated trials and working knowledge of ICH-GCP guidelines.
- Phlebotomy certification and clinical skills (vital signs, ECGs, specimen processing).
- Exceptional organizational skills, attention to detail, and ability to manage multiple studies simultaneously.
- Strong communication and leadership abilities with a collaborative approach to teamwork.
If you are an experienced clinical research professional passionate about advancing medical knowledge and improving patient care, we invite you to apply. Join our Pennsylvania-based research team and contribute to innovative, life-changing clinical studies that make a real impact.
Please send your updated resume through to i.marland@x4lifesciences.com