Clinical Research Coordinator II – Oncology

🔥 12 hours ago

🇪🇸 Spain – Remote

⏱ Part Time

🟢 Junior

🧪 Clinical Research

👻 Ghost score 10%

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• 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%

🎯 Requirements

• 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

🏖️ Benefits

• 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