Clinical Research Associate II - Spain

OpenKrill; United States; On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Home-based flexibility

International trials

Collaborative team

Competitive package

Job summary

Openkrill is seeking an experienced Clinical Research Associate II to oversee investigative sites across Spain, ensuring trials adhere to study protocols, ICH-GCP, and regulatory requirements. The role emphasizes patient safety, data integrity and timely study milestones.

You will conduct site qualification, initiation, monitoring and close-out visits, manage investigator relationships, support TMF documentation and collaborate with cross-functional teams on international trials.

Qualifications

• Minimum 4 years' clinical research experience.
• Minimum 2 years' monitoring experience as a CRA.
• Strong knowledge of ICH-GCP and site management.
• Fluent in Spanish and English; Portuguese desirable.
• Valid driver's license and willingness to travel up to 75%.

Responsibilities

• Conduct site qualification, initiation, monitoring, and close-out visits.
• Ensure patient safety, data integrity, and protocol compliance.
• Perform source data verification and review study documentation.
• Manage site relationships and provide ongoing investigator support.
• Assist with ethics and regulatory submissions as required.
• Monitor investigational product accountability and site performance.
• Maintain Trial Master File (TMF) documentation and support queries.
• Collaborate with cross-functional teams to deliver trials.

Skills

Site monitoring

Data integrity

Communication

Independent work

Travel readiness

Education

Life Sciences degree

CRA training

Job description

Are you an experienced Clinical Research Associate looking to join a dynamic and growing clinical research organisation? We are seeking a CRA II to manage investigative sites across Spain, ensuring clinical trials are conducted in accordance with study protocols, ICH-GCP, and applicable regulatory requirements.

Key Responsibilities

• Conduct site qualification, initiation, monitoring, and close-out visits.
• Ensure patient safety, data integrity, and protocol compliance.
• Perform source data verification and review study documentation.
• Manage site relationships and provide ongoing support to investigators and study staff.
• Assist with ethics committee and regulatory submissions where required.
• Monitor investigational product accountability and site performance.
• Maintain Trial Master File (TMF) documentation and support query resolution.
• Collaborate with cross-functional study teams to ensure successful trial delivery.

About You

• Life Sciences degree or equivalent experience, plus recognized CRA training.
• Minimum 4 years' clinical research experience.
• Minimum 2 years' monitoring experience as a CRA.
• Strong knowledge of ICH-GCP, clinical trial regulations, and site management.
• Fluent in Spanish and English languages, Portuguese is desirable
• Excellent communication, organisation, and problem-solving skills.
• Ability to work independently and manage multiple priorities.
• Valid driver's license and willingness to travel up to 75%.

What We Offer

• Home-based flexibility.
• Opportunity to work on international clinical trials.
• Collaborative and supportive team environment.
• Competitive salary and benefits package.