Clinical Research Associate II

SOLTI #cancerresearch; Barcelona; Hybrid; EUR 36,000 - 48,000; Full time

Job summary

SOLTI is seeking a CRA II to join our Clinical Operations Team in Barcelona. You will plan and conduct site visits, oversee trial medication logs, and collaborate with the project team to ensure compliance with GCP and protocol.

We require a Life Science degree, MSc in Clinical Trials Monitoring, at least 2 years of CRA experience, advanced English, and proficiency in MS Office. The role is full-time (38h/week) based in Barcelona with up to 3 days remote.

Qualifications

• BSc in Life Science or related field.
• MSc in Clinical Trials Monitoring required or preferred.
• Minimum 2 years of professional CRA experience in CRO/pharma or similar groups.
• Advanced English level.
• Advanced knowledge of GCPs and clinical trials legislation.
• Proficiency in MS Office.

Responsibilities

• Plan and conduct site visits and prepare site visit reports within timelines.
• Perform site management and ensure follow-up/action-item resolution.
• Oversee trial medication at the site by reviewing accountability logs.
• Ensure proper collection and dispatch of biosamples per protocol.
• Collaborate with trial team in managing documentation.
• Assist for audit/inspection activities as necessary.
• Ensure compliance with protocol, GCPs and regulations.
• Maintain communication with PM/CTM and report issues concerning sites.

Skills

CRA experience

Advanced English

MS Office

GCP knowledge

Education

BSc Life Science

MSc Clinical Trials Monitoring

Tools

MS Office

Job description

SOLTI is an academic research group that performs clinical trials of excellence in oncology. Currently, SOLTI is comprised of over 550 renowned research professionals distributed over a broad network of more than 100 leading hospitals in Spain, Portugal, France and Ireland.

SOLTI focuses its efforts on developing cutting-edge clinical trials with novel targeted therapeutics including innovative translational research, fostering the participation in international networks and promoting excellence in the management of cancer among their members.

We are currently seeking a CRA II to join our Clinical Operations Team.

Main responsibilities:

• Plan and conduct site visits and prepare site visit reports within the specified timelines in accordance with the Clinical Monitoring Plan.
• Perform site management and ensure thorough follow-up and resolution of action items.
• Oversee trial medication at the site by meticulously reviewing study accountability logs.
• Guarantee the proper collection and dispatch of biosamples as per protocol.
• Collaborate with the clinical project team in managing trial documentation.
• Provide assistance for audit/inspection activities as necessary.
• Ensure compliance with the protocol, Good Clinical Practices (GCPs), and clinical trial regulations.
• Maintain consistent communication with the PM/CTM and report any pertinent issues concerning the assigned trial sites.

Requirements and skills:

• BSc in Life Science field (Pharmacy, Biology, Nursing, etc.).
• MSc in Clinical Trials Monitoring.
• Minimum 2 years of professional experience as CRA in a CRO, Pharmaceutical Industry or collaborative groups. Breast cancer clinical trials experience will be an asset.
• Advanced English level.
• Advanced knowledge of GCPs and clinical trials legislation.
• Proficiency in MS Office.

This is a full-time position (38h/week) based in Barcelona (Spain).

What we offer:

Explore the opportunity of joining an organization engaged in cutting-edge projects with significant social impact.

We offer a full-time position based in Barcelona with the possibility of working from home up to 3 days a week with a flexible work schedule and additional benefits.

SOLTI is an employer committed to Equal Opportunities regardless of sex, gender, sexual orientation, race, age, origin or disability.