Senior Clinical Research Associate

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

📋 Description

• Independently perform site monitoring duties for clinical trials.

• Offer oversight, leadership, and direction in the management and execution of clinical trials.

• Ensure adherence to protocols and maintain quality standards.

• Guide, supervise, and provide constructive feedback to the CRA team concerning project scope, SOPs, timelines, and budgets.

• Evaluate and review monitoring visit reports and conduct co-monitoring and evaluation visits.

• Organize investigator site visits and facilitate cross-functional issue resolution.

• Assist in the development of study-specific Monitoring Plans, training presentations, ethics documentation, and site contract negotiations.

• Supply monthly billing information to the finance department.

• Oversee study budgets and act as the sponsor referent for independent projects.

• Conduct qualification, initiation, interim, and close-out visits both remotely and on-site.

• Create detailed monitoring visit reports addressing site issues, resolutions, protocol deviations, study progress, and enrollment data.

• Review source documents and confirm the integrity of CRF data.

• Execute quality control and verification of eTMF/TMF documents.

• Manage investigational product accountability and assess site regulatory binders.

• Maintain communication with study sites regarding protocol/GCP compliance, patient enrollment, and sponsor requests.

• Ensure adherence to ICH GCP, FDA regulations, and company/sponsor SOPs.

• Facilitate the reporting of adverse events and reconcile SAE reports with source documentation and CRFs.

• Address data discrepancies in collaboration with in-house CRAs/CTC and data management.

• Identify site-related issues and formulate problem-solving strategies.

• Prepare study sites for audits.

• Assist in CRA training, onboarding, and mentoring initiatives.

• Collaborate on the development and maintenance of CTMS.

• Manage competing priorities and undertake additional duties as assigned.

⛳️ Requirements

• US: Bachelor's degree (BS/BA) from an accredited undergraduate program, preferably in life sciences or a related field.

• US: A minimum of 3 years of experience in the pharmaceutical, biotechnology, or CRO industry.

• US: At least 2 years of clinical monitoring experience, including 1 year in a management role.

• EU: At least 2 years of clinical monitoring experience in the pharmaceutical, biotechnology, or CRO industry, with the ability to independently manage monitoring activities.

• Quality-oriented; meticulous, thorough, and detail-oriented.

• Excellent organizational skills with the ability to multitask in a fast-paced environment.

• Strong capability to manage priorities, organize time effectively, and resolve issues.

• Proficient analytical, negotiation, meeting management, cross-functional team collaboration, and leadership skills.

• Willingness to travel as required.

• Strong proficiency in the local language, both written and verbal, in the country where monitoring activities are conducted.

• US: Strong command of the English language, both written and verbal.

• Exceptional communication and interpersonal skills with a focus on customer service.

• Competent computer skills, including familiarity with clinical trial management systems, clinical trial databases, and electronic data capture.

• Understanding of clinical research, ICH GCP, and local regulations.

• Knowledge of regulatory and ethical standards.

• EU: Degree in a scientific health discipline.

• EU: Proficiency in English.

• EU (Italy): Certification as a Monitor in accordance with the Italian CRO decree dated November 15, 2011.

• US: Permanent authorization to work in the U.S.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health insurance coverage.

• Opportunities for professional development and training.

• Flexible work arrangements and work-life balance initiatives.

• Supportive and collaborative work environment.