Senior Clinical Research Associate – Onco/CNS

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

📋 Description

• Oversee site qualification, initiation, interim monitoring, management, and close-out activities.

• Ensure patient safety and data integrity through informed consent and safety-information reviews, source document verification, CRF reviews, and resolution of queries.

• Assist sites in adhering to protocols, maintaining Investigator Site Files, managing regulatory and ethics documentation, ensuring investigational product accountability, and fulfilling ongoing study requirements.

• Act as Lead CRA to coordinate CRAs on global studies.

• Provide mentorship and training to less experienced colleagues and site staff, including participating in site visits.

• Collaborate with Project Management and study teams on deliverables, study milestones, site performance, and monitoring activities.

• Create monitoring plans, study-specific tools, templates, and training resources.

• Assess site visit reports and offer constructive feedback and edits.

• Ensure the proper maintenance of site documentation for filing in the Trial Master File.

• Bring clinical monitoring expertise to study team and investigator meetings, bid defenses, as well as protocol and CRF design.

⛳️ Requirements

• MD or Pharmacy qualification (MSPH, PharmD, PhD, equivalent Pharmacy degree, or similar) with a minimum of 3 years’ CRA experience; or a four-year college degree in a relevant science with at least 5 years’ CRA experience; or a two-year college degree or equivalent education/training, preferably in nursing or a related life science degree, with at least 7 years’ CRA experience.

• In-depth knowledge of clinical research principles and processes.

• Comprehensive understanding of FDA and/or EU regulations and directives, ICH Guidelines, local regulatory requirements, and SOPs.

• Strong expertise in two to three therapeutic areas.

• Exceptional communication, interpersonal, planning, organizational, time-management, initiative, and problem-solving abilities.

• Capability to lead and inspire an assigned team when necessary.

• Proficient in Microsoft Office, IxRS, and electronic data capture (EDC) systems.

• Valid current passport and driver's license.

• Willingness to travel as needed.

• Proficient in both spoken and written English.

• Fluency in the local languages of the countries for which responsibilities are held.

🏝️ Benefits

• A collaborative and inclusive work environment.

• Opportunities for growth and learning.

• Home-based work arrangement.

• Chance to serve as Lead CRA on global studies.

• Mentoring and training opportunities.

• Collaboration with global study teams.