Senior Clinical Research Associate - Onco/CNS (Spain)

WCT Clinical Research Spain, S.L.; Barcelona; Hybride; EUR 55 000 - 75 000; Plein temps

Résumé du poste

Worldwide Clinical Trials seeks a Senior Clinical Research Associate for a home-based role supporting sites across Spain. You will lead site qualification, monitoring, and close-out activities, ensuring patient safety and data integrity across studies.

Qualifications include a medical or pharmacy degree with CRA experience and ability to travel 8–10 days per month. Fluency in English and local languages is required; MS Office, IxRS, and EDC skills are preferred.

Qualifications

• Experience as a CRA and monitoring across sites.
• Strong knowledge of FDA/EU regulations and ICH guidelines.
• Ability to travel ~8–10 days per month.
• Fluent in English; local language proficiency.

Responsabilités

• Lead site qualification, initiation, interim monitoring, management, and close-out activities.
• Protect patient safety and data integrity through source verification and data review.
• Guide sites in regulatory and ethics documentation and site file maintenance.
• Coordinate CRAs as Lead CRA on global studies and mentor staff.
• Collaborate with project teams to evaluate milestones and site performance.
• Develop monitoring plans, tools, and training materials.
• Review site visit reports and file documentation in the Trial Master File.
• Contribute monitoring expertise to investigator meetings and protocol design.

Connaissances

Communication

Interpersonal skills

Planning

Organization

Time management

Initiative

Problem solving

Leadership

Formation

MD or Pharmacy qualification

4-year college + 5 years CRA experience

2-year college + nursing/life science + 7 years CRA

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.

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.

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.

We’re a team of clinicians, scientists, and researchers who want to make healthcare better. We were founded on an unwavering commitment to authentic, personalized attention. And today, as CROs consolidate and the industry changes rapidly, that personalized attention is more important than ever. We all came to this industry for different reasons, from different walks of life. If you ask any one of us why we’re here, you’ll get a different answer. And that’s what makes us special.