Clinical Research Coordinator II – Oncology

• Review assigned protocols and study documentation for accuracy, feasibility, timing, and resources
• Prepare and maintain Investigator Site Files and/or Trial Master Files
• Participate in timelines, start-up meetings, and sponsor discussions
• Coordinate study start-up activities, clinic logistics, training, source documents, CRFs, laboratory workbooks, staffing, schedules, safety assessments, quality control, monitoring plans, pharmacy requirements, supplies, and regulatory documentation
• Support the Principal Investigator with delegation logs, daily tasks, visit calendars, monitor visits, and participant recruitment and screening
• Perform study activities according to Good Clinical Practices
• Manage multiple clinical trials simultaneously and protect participant safety
• Collect and enter study data, complete Case Report Forms, submit data, and facilitate audits
• Coordinate screening and informed consent activities
• Supervise clinic visits, provide on-call support, screen eligibility, and oversee or perform study drug administration as delegated
• Monitor study activities for compliance with protocol, SOPs, and applicable regulations
• Manage clinic updates, adverse event and serious adverse event reporting, study logs, trackers, quality control, and monitor findings
• Coordinate resolution of QC, monitor, CRF, and other findings
• Oversee study close-out documentation, deviations, CRF completion, TMF updates, logs, supplies return, IRB reports, and archiving
• Monitor participant compliance and escalate trial or study issues
• Prepare for and participate in sponsor, monitor, and QA audits
• Provide timely project status updates to Project Managers and sponsors
• Collaborate on process improvement, SOP creation/revision, meetings, and company initiatives
• Coordinate regulatory activities, including protocol, consent, amendment, and yearly renewal submissions
• Report trial-related adverse events and maintain study files
• Perform other assigned work-related duties
• Travel up to 100%

• Registered Nurse and/or University Degree such as Bachelor of Science Degree required
• Clinical Research certification preferred
• Minimum of 1 year experience in clinical research required; 2+ years preferred
• Good knowledge of regulations, ICH GCP, privacy, and applicable guidelines
• Problem solving, planning, and evaluation skills
• Good time management and attention to detail; ability to multitask
• Good interpersonal and communication skills with a team focus
• Knowledge of SOP writing
• Ability to anticipate problems and provide timely solutions
• Ability to coordinate multiple clinical research projects with competing deadlines
• Proficiency in Word, Excel, and PowerPoint
• Proficiency in clinical trial EDC software preferred
• Experience in Oncology
• Ability to travel up to 100%
• Equivalent experience, skills, and/or education may be considered

• Permanent part-time employment
• Remote work (pre-approved)
• Flexible schedule, including days, afternoons, nights, and weekends
• Opportunity to work on clinical research projects across diverse therapeutic areas
• Reasonable accommodations, when appropriate, for employees or applicants with disabilities