Clinical Research Coordinator II – Oncology

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

📋 Description

• Evaluate assigned protocols and study documents for accuracy, feasibility, timeline, and resources

• Create and manage Investigator Site Files and/or Trial Master Files

• Engage in timelines, start-up meetings, and discussions with sponsors

• Oversee study start-up tasks, clinic logistics, training, source documentation, CRFs, laboratory workbooks, staffing, schedules, safety evaluations, quality control, monitoring plans, pharmacy needs, supplies, and regulatory paperwork

• Assist the Principal Investigator with delegation logs, daily responsibilities, visit schedules, monitoring visits, and participant recruitment and screening

• Conduct study activities in accordance with Good Clinical Practices

• Handle multiple clinical trials at once while ensuring participant safety

• Gather and input study data, complete Case Report Forms, submit data, and facilitate audits

• Organize screening and informed consent processes

• Supervise clinic visits, offer on-call assistance, evaluate eligibility, and manage or administer study drugs as assigned

• Monitor study activities for adherence to protocols, SOPs, and relevant regulations

• Manage clinic updates, adverse event reporting, study logs, trackers, quality control, and monitor findings

• Coordinate the resolution of QC, monitor, CRF, and additional findings

• Oversee study close-out documentation, deviations, CRF completion, TMF updates, logs, supply returns, IRB reports, and archiving

• Track participant compliance and escalate any trial or study 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/revisions, meetings, and company initiatives

• Coordinate regulatory tasks, including protocol, consent, amendment, and annual renewal submissions

• Report trial-related adverse events and maintain study documentation

• Carry out other assigned job-related duties

• Willingness to travel up to 100%

⛳️ Requirements

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

• Clinical Research certification is preferred

• A minimum of 1 year of experience in clinical research is required; 2+ years is preferred

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

• Excellent problem-solving, planning, and evaluation skills

• Strong time management and attention to detail; ability to juggle multiple tasks

• Good interpersonal and communication skills with a team-oriented approach

• Familiarity with SOP writing

• Capability to foresee problems and provide prompt solutions

• Ability to manage multiple clinical research projects with competing deadlines

• Proficient in Word, Excel, and PowerPoint

• Familiarity with clinical trial EDC software is preferred

• Experience in Oncology

• Willingness to travel up to 100%

• Equivalent experience, skills, and/or education may be taken into account

🏝️ Benefits

• Permanent part-time position

• Remote work available (with prior approval)

• Flexible scheduling, including days, afternoons, nights, and weekends

• Opportunity to engage in clinical research projects across a variety of therapeutic areas

• Reasonable accommodations available for employees or applicants with disabilities, when appropriate