Clinical Research Coordinator II, Oncology

This is a fully remote position, open to applicants in Spain.

📋 Description

• Evaluate assigned protocols and associated documentation for precision, feasibility, timing, and resource allocation.

• Prepare and uphold Investigator Site Files and/or Trial Master Files.

• Engage in timelines, start-up meetings, Investigator Meetings, Site Initiation Visits, and discussions with sponsors.

• Organize study start-up activities, including clinic logistics, scheduling, team training, source documents, CRFs, laboratory workbooks, staffing, and study supplies.

• Verify regulatory and contractual documentation prior to the commencement of the study.

• Assist the Principal Investigator with delegation logs, daily task oversight, visit calendars, and monitoring visits.

• Promote, recruit, and screen potential study participants.

• Conduct study activities in alignment with Good Clinical Practices.

• Manage multiple clinical trials concurrently while ensuring participant safety.

• Gather and input study data; complete Case Report Forms and ensure timely data submission.

• Coordinate screening processes and aid in informed consent procedures.

• Facilitate audits of study data and address auditor inquiries for data clarification.

• Manage clinic visits, including admission, dosing, randomization, discharge, and follow-up.

• Provide on-call support when necessary.

• Screen eligibility and oversee, coordinate, and/or execute study-drug administration as assigned.

• Monitor study activities to ensure compliance with protocols, SOPs, and relevant regulations.

• Manage adverse-event reporting, study logs, trackers, quality control, and monitor findings.

• Coordinate QC, monitoring, CRF, and other findings until resolution.

• Supervise study close-out documentation, deviation reporting, CRF completion, TMF updates, logs, supply returns, IRB reports, and archiving.

• Monitor participant compliance and escalate any participant or study-related issues.

• Prepare for and engage in sponsor, monitor, and QA audits.

• Provide timely updates on project status to Project Managers and sponsors.

• Collaborate on process enhancements, SOP development/revision, meetings, and company initiatives.

• Coordinate and execute regulatory activities, including protocol, consent, amendment, and annual renewal submissions as required.

• Report trial-related adverse events and maintain study documentation.

• Carry out other assigned work-related tasks.

⛳️ Requirements

• A Registered Nurse and/or a University Degree, such as a Bachelor of Science Degree, is required.

• Clinical Research certification is preferred.

• At least 1 year of experience in clinical research is necessary; 2+ years is preferred.

• Strong understanding of regulations, ICH GCP, privacy, and applicable guidelines.

• Excellent problem-solving, planning, and evaluation skills.

• Effective time management; detail-oriented with the ability to multitask.

• Strong interpersonal and communication skills with a focus on teamwork.

• Familiarity with SOP writing.

• Capability to anticipate challenges and provide timely solutions.

• Ability to manage multiple clinical research projects with competing deadlines.

• Proficiency in Word, Excel, and PowerPoint.

• Experience with clinical trial EDC software is preferred.

• Willingness to accommodate a flexible schedule, including days, afternoons, nights, and weekends.

• Willingness to travel up to 100%.

• Equivalent experience, skills, and/or education may be considered.

🏝️ Benefits

• Temporary part-time employment.

• Remote (Pre-Approved) work designation.

• Flexible scheduling to accommodate days, afternoons, nights, and weekends.