Medasource · 22 hours ago
Senior Clinical Research Coordinator
Responsibilities
Lead and manage daily operations for assigned clinical research projects and trials, ensuring timelines and milestones are met
Independently screen, track, and enroll patients in clinical trials and research studies
Coordinate and attend sponsor visits, monitoring visits, and site audits
Enroll human subjects, obtain informed consent, and conduct complex clinical assessments
Ensure accurate, timely data collection and entry in clinical research systems
Organize, maintain, and ensure accuracy of study documentation and audit-ready regulatory binders
Serve as a primary resource to the Principal Investigator (PI) regarding patient responses, medication administration, and adverse events
Identify, assess, and escalate complex study-related issues as needed
Prepare, review, and submit IRB and regulatory documents; support amendments, continuing reviews, and study close-outs
Ensure compliance with FDA, IRB, Pennsylvania state regulations, and institutional policies
Provide advanced administrative and technical support to enhance study quality and operational efficiency
Participate in research meetings and may assist with grant submissions or manuscript preparation
Mentor and support junior clinical research staff as needed
Perform other duties as assigned
Qualification
Required
Bachelor's degree in a life science or health-related field
Minimum of four years of clinical research experience
Equivalent combinations of education and experience will be considered
Proficiency in MS Office Suite and clinical research databases
Strong knowledge of clinical research processes, medical terminology, and human subject protections
Excellent written and verbal communication skills
Ability to independently solve complex problems and make sound decisions
Highly organized with strong attention to detail
Ability to manage multiple studies in a fast-paced environment
Professional and effective when working with investigators, sponsors, staff, and participants
Flexible to work evenings, weekends, or extended hours as needed
Willingness to travel to off-site locations
Preferred
Prior experience with IRB submissions
Experience processing and shipping biological samples
Phlebotomy certification or willingness to obtain
Experience with REDCap, OnCore CTMS, Epic Research, and Florence eBinders
Electronic Data Capture (EDC) data entry experience
Clinical research experience in a healthcare setting
Experience with NIH-sponsored studies, industry clinical trials, and investigator-initiated research