Clinical Research Coordinator /Research Nurse - Freelance
hace 4 días
Madrid
POSITION SUMMARY: We are seeking a detail-oriented and experienced Clinical Data Coordinator (CDC) to support a Phase 3, multinational, multicenter, randomized trial evaluating an investigational product for Cardiomyopathy. The CDC will work closely with the Principal Investigator (PI) and site team to ensure the study is conducted in compliance with ICH-GCP, protocol specifications, and applicable regulations. POSITION: Clinical Data Coordinator (CDC) – Transthyretin Amyloidosis with Cardiomyopathy Clinical Trial LOCATION: On-site in Madrid, Spain POSITION TYPE: Contractor / Freelance DURATION OF CONTRACT: 4-6 Months WORK HOURS: Approximately 60 hours per month BENEFITS: No Benefits EXPENSES: Contractor's responsibility ESSENTIAL JOB FUNCTIONS: 80% Study Coordination & Data Management • Ensure all protocol-mandated procedures are completed and documented accurately and in a timely manner., • Abstract clinical data from medical records to complete CRFs and respond to data queries., • Maintain source documents and electronic records in an audit-ready state., • Participate in sponsor monitoring visits and resolve data discrepancies., • Facilitate subject safety through AE documentation and reporting in accordance with sponsor and regulatory timelines., • Attend sponsor teleconferences and site meetings as required., • Participate in site monitoring visits, assist with SDV, and address findings., • Coordinate with the PI and site team to communicate protocol deviations or other study-related issues., • Participate in internal team meetings., • Act as a point of reference for protocol-specific questions from site staff., • Perform related responsibilities as requested by the PI or sponsor. QUALIFICATIONS Minimum of 2 years’ experience as a Clinical Research Coordinator/Clinical Data Coordinator in interventional drug trials, ideally within cardiology settings. Bachelor’s degree in life sciences, healthcare, or a related field Proficient in ICH-GCP, local regulatory guidelines, and data documentation standards. Strong organizational skills, both written and verbal, with exceptional attention to detail. Ability to work independently while collaborating effectively with a multidisciplinary team. REQUIRED SKILLS: Excellent written and verbal communication skills English and Spanish proficiency. Strong organizational, multitasking, and data entry abilities. Comfortable with clinical systems and technology (e.g., EDC, CTMS). Commitment to confidentiality, integrity, and protocol adherence. Familiarity with eClinical tools, including ePRO, EDC, EMR, and clinical trial management software. Experience working as an independent contractor preferred. Experience with interventional industry-sponsored clinical trials Knowledge of the regulations impacting the conduct of clinical trials, including but not limited to the Spanish Medicines and Medical Devices Agency (AEMPS), Ethics Committees for Research with Medicinal Products (CEIms), Spanish Data Protection Agency (AEPD), and the Ministry of Health and European Medicines Agency (EMA)
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5 Calle del Tejo, Arganzuela, 28045, Madrid
