Global Start-Up CRA: Activation & Compliance

Parexel; Medellín; On-site; COP 36,000,000 - 60,000,000; Full time

Job summary

Parexel is seeking an Initiation Clinical Research Associate (iCRA) to lead study start-up activities from site identification to activation and ongoing maintenance in a global, matrix environment. You will manage regulatory submissions, site readiness, and activation timelines while ensuring compliance with sponsor requirements.

The role emphasizes strong stakeholder engagement, high attention to detail, and experience with CTMS/eTMF/TMF systems.

Qualifications

• Experience in clinical research and study start-up.
• Ability to manage regulatory submissions and site documents with accuracy.
• Strong communication and stakeholder management skills.
• Comfort with working in global, matrix, multicultural environments.
• Excellent written and spoken English.

Responsibilities

• Lead and execute start-up, pre-SIV, activation, and amendment activities from site identification through activation and maintenance.
• Serve as primary contact for assigned sites and ensure site readiness and compliance.
• Prepare, review, and execute regulatory and site documents including CDAs and ICFs.
• Coordinate regulatory submissions with IRBs/IECs and regulatory authorities.
• Develop activation plans, timelines, and regulatory strategies.
• Maintain high-quality documentation in CTMS, eTMF, and TMF systems.
• Identify and address site issues related to activation, recruitment, and data quality.
• Support sites with system access, training, and readiness activities.
• Ensure audit- and inspection-readiness throughout the study lifecycle.
• Maintain compliance with ICH-GCP and Parexel SOPs.
• Collaborate across functions to meet milestones and communicate progress.

Skills

Regulatory submissions

Site activation

Stakeholder management

Documentation quality

English proficiency

Education

Bachelor's degree in Life Sciences, Pharmacy, Nursing, or another health-related field

Tools

CTMS

eTMF

TMF

Microsoft Office

Job description

Parexel is seeking an Initiation Clinical Research Associate (iCRA) to lead study start-up activities from site identification to activation and ongoing maintenance in a global, matrix environment. You will manage regulatory submissions, site readiness, and activation timelines while ensuring compliance with sponsor requirements.

The role emphasizes strong stakeholder engagement, high attention to detail, and experience with CTMS/eTMF/TMF systems.