Clinical Research Coordinator II, Oncology

• Review assigned protocols and related documentation for accuracy, feasibility, timing, and resources
• Prepare and maintain Investigator Site Files and/or Trial Master Files
• Participate in timelines, start-up meetings, Investigator Meetings, Site Initiation Visits, and sponsor discussions
• Coordinate study start-up activities, clinic logistics, schedules, team training, source documents, CRFs, laboratory workbooks, staffing, and study supplies
• Confirm regulatory and contractual documentation before study start
• Support the Principal Investigator with delegation logs, daily task management, visit calendars, and monitor visits
• Advertise, recruit, and screen potential study participants
• Perform study activities in accordance with Good Clinical Practices
• Manage multiple clinical trials simultaneously and protect participant safety
• Collect and enter study data; complete Case Report Forms and submit data on time
• Coordinate screening and assist with informed consent
• Facilitate study-data audits and respond to auditor data-clarification inquiries
• Coordinate clinic visits, including admission, dosing, randomization, discharge, and follow-up
• Provide on-call support when applicable
• Screen eligibility and oversee, coordinate, and/or perform study-drug administration as delegated
• Monitor study activities for compliance with protocol, SOPs, and applicable regulations
• Manage adverse-event reporting, study logs, trackers, quality control, and monitor findings
• Coordinate QC, monitor, CRF, and other findings through resolution
• Oversee study close-out documentation, deviation reporting, CRF completion, TMF updates, logs, supply returns, IRB reports, and archiving
• Monitor participant compliance and escalate participant 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 and perform regulatory activities, including protocol, consent, amendment, and yearly renewal submissions when requested
• Report trial-related adverse events and maintain study files
• Perform other assigned work-related duties

• Registered Nurse and/or University Degree such as Bachelor of Science Degree required
• Clinical Research certification preferred
• Minimum of 1 year of 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; detail-oriented and able 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
• Ability to accommodate a flexible schedule, including days, afternoons, nights, and weekends
• Travel up to 100%
• Equivalent experience, skills, and/or education may be considered

• Temporary part-time employment
• Remote (Pre-Approved) designation
• Flexible schedule accommodating days, afternoons, nights, and weekends