Senior Clinical Research Associate – Oncology, Hematology

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

📋 Description

• Oversee site qualification, initiation, interim monitoring, management, and closure activities.

• Safeguard patient safety and data integrity by assessing informed consent and safety documentation.

• Execute source document verification and review case report forms (CRFs).

• Facilitate prompt resolution of queries.

• Assist sites with protocol compliance, maintenance of the Investigator Site File, regulatory and ethics documentation, investigational product accountability, and ongoing study obligations.

• Coordinate Clinical Research Associates (CRAs) as a Lead CRA on international studies.

• Provide mentorship, training, site visits, and practical advice to less experienced colleagues and site personnel.

• Collaborate with Project Management and study teams to assess deliverables, study milestones, site performance, and monitoring tasks.

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

• Review site visit reports, offering constructive feedback and edits.

• Ensure that pertinent site documentation is preserved for inclusion in the Trial Master File.

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

• Travel to investigative sites approximately 8–10 days per month.

⛳️ Requirements

• Medical Doctor (MD) or Pharmacy qualification (MSPH, PharmD, PhD, equivalent Pharmacy degree, or similar) with a minimum of 3 years of CRA experience; alternatively, a four-year college degree in a relevant science with at least 5 years of 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 of CRA experience.

• Comprehensive understanding of clinical research principles and processes.

• In-depth knowledge of FDA and/or EU regulations and directives, ICH Guidelines, local regulatory requirements, and Standard Operating Procedures (SOPs).

• Strong therapeutic-area expertise in two to three specific therapeutic areas.

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

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

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

• Valid current passport and driving license.

• Openness to travel as needed.

• Proficiency in both spoken and written English.

• Fluency in the local languages of the countries for which responsibility is held.

🏝️ Benefits

• Collaborative and inclusive work environment.

• Opportunities for growth and development.

• Home-based work arrangement.

• Chance to serve as Lead CRA on global studies.

• Mentoring and training opportunities available.

• Collaboration with global study teams.