Senior Clinical Research Associate – Oncology/Hematology

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

📋 Description

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

• Ensure patient safety and data integrity by reviewing informed consent, verifying source documents, auditing CRFs, overseeing safety information, and resolving data queries.

• Collaborate with study teams, Project Management, investigators, and site personnel on deliverables, milestones, protocol compliance, and site performance.

• Act as a Lead CRA to coordinate Clinical Research Associates on global studies.

• Offer mentorship, training, accompanied visits, and practical advice to colleagues and site teams.

• Maintain documentation related to regulatory, ethics, sites, and Trial Master Files (TMF).

• Handle study materials, Investigator Site Files, and accountability for investigational products.

• Prepare and review reports from monitoring visits.

• Contribute to the development of Clinical Monitoring Plans, study tools, protocols, CRFs, training materials, investigator meetings, and bid defenses.

• Communicate with sites and study stakeholders, addressing issues throughout the study lifecycle.

• Travel to investigative sites approximately 6–8 days per month.

⛳️ Requirements

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

• In-depth knowledge of clinical research, GCP, FDA and/or EU regulations and directives, ICH Guidelines, local regulatory requirements, SOPs, monitoring, and site management activities.

• Strong therapeutic area expertise and a comprehensive understanding of two to three therapeutic areas.

• Excellent communication, planning, organization, interpersonal, problem-solving, and time-management abilities.

• Capacity to lead and inspire an assigned team where applicable.

• Proficiency in Microsoft Office, IxRS, and electronic data capture systems.

• Valid current passport and driving license.

• Willingness to travel.

• Fluency in the local languages of the relevant countries.

• Proficient in spoken and written English.

• Experience in full-service monitoring is preferred.

🏝️ Benefits

• Collaborative and inclusive work environment.

• Opportunities for growth and career development.

• Learning opportunities available.

• Home-based work arrangement.

• Opportunity to serve as a Lead CRA on global studies.

• Mentorship and guidance opportunities.

• Collaboration with global study teams.