Senior Clinical Research Associate
hace 11 días
Barcelona
Overview Senior Clinical Research Associate (SR CRA) – Spain. The SR CRA is a key member of the Alira Health Clinical team responsible for site monitoring, ensuring compliance and quality of clinical trials. Salary range: €55,000 – €65,000. Key Responsibilities • Provide guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements., • Review monitoring visit reports and conduct co‑monitoring and evaluation visits as needed., • Ensure appropriate and timely investigator site visits and assist with study recruitment, site training, and other site‑related issues., • Coordinate with cross‑functional departments to facilitate negotiation or issue resolution related to clinical trial monitoring., • Assist in development of study‑specific Monitoring Plans and training presentations., • Assist in setup and collection of site‑specific ethics documents and site contract negotiation., • Provide monthly billing information to the finance team., • Manage study budget and act as referent for the sponsor on stand‑alone monitoring projects., • Perform qualification, initiation, interim, and close‑out visits both remotely and onsite, documenting site‑related problems, resolutions, actions, protocol deviations, study progress, and enrollment status., • Ensure integrity of CRF data through thorough source document review and verification., • Perform quality control and verification of documents collected at sites for eTMF/TMF., • Conduct investigational product accountability and review site regulatory binder for required documents., • Maintain regular contact with study sites to ensure protocol/GCP compliance, assess patient accrual rates, and respond to sponsor requests., • Comply with and ensure team compliance with ICH GCP guidelines, FDA regulations, and company/sponsor SOPs., • Participate in internal, client/sponsor, scientific, and other meetings as required., • Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs., • Resolve queries on discrepant data in coordination with in‑house CRAs, CTC, and data management., • Proactively identify site issues and develop problem‑solving strategies., • Conduct audit preparation at study sites as needed., • Collaborate with other CRAs to maintain consistency and promote a collaborative team atmosphere., • Assist in CRA new hire training, onboarding, and mentoring., • Collaborate in development and maintenance of the Clinical Trial Management System (CTMS)., • Manage and resolve conflicting priorities to deliver on commitments., • Perform additional duties as assigned.Desired Qualifications & Experience, • US: BS/BA in a life sciences or related discipline., • US: 3 years of experience in the pharmaceutical/biotechnology/CRO industry, 2 years of clinical monitoring experience, and 1 year of management experience., • EU: Minimum 2 years of clinical monitoring experience in the pharmaceutical/biotechnology/CRO industry and the ability to autonomously manage monitoring activities.Technical Competences & Soft Skills, • Quality focused; detail‑oriented and thorough., • Strong organizational and multi‑tasking skills; ability to work effectively in a fast‑paced environment., • Ability to manage priorities, organize time, and solve problems., • Strong analytical, negotiation, meeting management, cross‑functional team, and leadership skills., • Ability to travel and manage stress., • Professional, trustworthy, and disciplined., • Problem‑solving unstructured or ambiguous challenges., • Strong command of English (US); local language (EU) and local regulations knowledge., • Excellent communication and interpersonal skills with customer service orientation., • Computer skills; ability to use CTMS, clinical trial databases, and electronic data capture., • Self‑starter in a collaborative but less structured team environment., • Knowledge of clinical research, ICH GCP, local regulations, and regulatory and ethical requirements. xcskxlj, • Ability to establish and maintain positive relationships with sponsor, site, and project team members. #J-18808-Ljbffr