Senior Clinical Research Associate - Spain - Oncology + Hematology - Remote

Worldwide Clinical Trials; Barcelona; À distance; EUR 60 000 - 80 000; Plein temps

Résumé du poste

Worldwide Clinical Trials in Spain is seeking a Senior Clinical Research Associate to protect patient safety, ensure data quality, and adhere to GCP, regulations, protocols, and SOPs. You will own full monitoring lifecycle from qualification to close-out, mentor CRAs, and collaborate with study teams while traveling to investigative sites about 8-10 days per month.

This home-based role requires English and local language fluency, and a strong background in clinical research and two to three

Qualifications

• MD/Pharmacy with CRA experience of 3+ years, or equivalent science degree with 5+ years CRA experience.
• Strong knowledge of FDA/EU regulations, ICH guidelines, and SOPs.
• Excellent communication and leadership abilities, with willingness to travel.

Responsabilités

• Lead site qualification, initiation, interim monitoring, management, and close-out activities.
• Protect patient safety and data integrity by reviewing informed consent and safety information, conducting source document verification, reviewing CRFs, and supporting timely query resolution.
• Guide sites in protocol adherence, Investigator Site File maintenance, regulatory and ethics documentation, investigational product accountability, and ongoing study requirements.
• Coordinate CRAs as a Lead CRA on global studies and provide mentoring, training, accompanied visits, and practical guidance to less experienced colleagues and site staff.
• Partner with Project Management and study teams to evaluate deliverables, study milestones, site performance, and monitoring activities.
• Develop monitoring plans, study-specific tools, templates, and training materials as requested to support consistent study delivery.
• Review site visit reports and provide feedback while maintaining site documentation for the Trial Master File.
• Contribute your clinical monitoring expertise to study team and investigator meetings, bid defenses, and the design of protocols and CRFs.

Connaissances

CRA experience

Regulatory knowledge

Communication

Leadership

EDC/IxRS

Travel readiness

Formation

MD or Pharmacy qualification

Nursing or related science degree

Outils

Microsoft Office

IxRS

EDC systems

Description du poste

Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials, we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world.

With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research.

Make an Impact as a Senior Clinical Research Associate at Worldwide

As a Senior Clinical Research Associate, you’ll play a key role in protecting patient safety, maintaining high-quality clinical data, and ensuring investigative sites deliver studies in line with Good Clinical Practice (GCP), regulatory requirements, protocols, and SOPs.

You’ll take ownership of the full site monitoring lifecycle, from qualification and initiation through interim monitoring, site management, and close-out. You’ll work closely with sites and study teams to strengthen protocol adherence, resolve data queries, maintain essential documentation, and ensure safety information is appropriately reviewed and reported.

You’ll also have the opportunity to bring your experience beyond individual sites, acting as a Lead CRA on global studies, coordinating and mentoring CRAs, contributing to monitoring plans, reviewing visit reports, delivering training, and supporting study milestones.

Where You'll Work

This is a home-based Clinical Research Associate role supporting sites across Spain. Candidates must reside within the territory to effectively support site visits and study activities. You will collaborate with sites, sponsors, and global study teams while traveling to investigative sites approximately 8-10 days per month.

What You'll Do

• Lead site qualification, initiation, interim monitoring, management, and close-out activities, ensuring compliance with protocols, GCP, applicable regulations, and SOPs.
• Protect patient safety and data integrity by reviewing informed consent and safety information, conducting source document verification, reviewing CRFs, and supporting timely query resolution.
• Guide sites in protocol adherence, Investigator Site File maintenance, regulatory and ethics documentation, investigational product accountability, and ongoing study requirements.
• Coordinate CRAs as a Lead CRA on global studies and provide mentoring, training, accompanied visits, and practical guidance to less experienced colleagues and site staff.
• Partner with Project Management and study teams to evaluate deliverables, study milestones, site performance, and monitoring activities.
• Develop monitoring plans, study-specific tools, templates, and training materials as requested to support consistent study delivery.
• Review site visit reports and provide clear feedback and edits while ensuring relevant site documentation is maintained for filing in the Trial Master File.
• Contribute your clinical monitoring expertise to study team and investigator meetings, bid defenses, and the design of protocols and CRFs.

What You'll Bring

• Education and CRA experience: an MD or Pharmacy qualification (MSPH, PharmD, PhD, equivalent Pharmacy degree, or similar) with at least 3 years’ CRA experience; or a minimum four-year college curriculum in medical, biological, physical, health, pharmacy, or another related science with at least 5 years’ CRA experience; or a two-year college curriculum or equivalent education/training, preferably a nursing or equivalent life science degree, with at least 7 years’ CRA experience.
• Extensive knowledge of clinical research principles and processes, with a thorough understanding of FDA and/or EU regulations and directives, ICH Guidelines, local regulatory requirements, and SOPs.
• Strong therapeutic-area expertise, with a thorough understanding of two to three therapeutic areas sufficient to operate as a Lead CRA where appropriate.
• Excellent communication, interpersonal, planning, organizational, time-management, initiative, and problem-solving skills, alongside the ability to lead and motivate an assigned team when applicable.
• Technical proficiency with Microsoft Office, IxRS, and electronic data capture (EDC) systems.
• Experience in full-service monitoring PREFERRED.
• Valid current passport and driving licence, with willingness to travel as required.
• Proficiency in spoken and written English, together with fluency in the local languages of the countries under responsibility.

Discover the Difference

We love knowing that someone is going to have a better life because of the work we do. Discover the Difference at Worldwide Clinical Trials.

Explore additional opportunities on our careers page, visit http://www.worldwide.com/careers, or connect with us on LinkedIn.