Initiation Clinical Research Associate - Icra

Parexel; Medellín; Vor Ort; COP 36.000.000 - 60.000.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Regulatory submissions

Site activation

Stakeholder management

Documentation quality

English proficiency

Ausbildung

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

Tools

CTMS

eTMF

TMF

Microsoft Office

Jobbeschreibung

When our values align, there's no limit to what we can achieve.

The Initiation Clinical Research Associate (iCRA) is responsible for leading and executing all study start-up, pre-SIV, activation, and protocol amendment activities from site identification through site activation and maintenance. Acting as the primary contact for assigned sites, the iCRA manages regulatory submissions, site readiness, document quality, and activation timelines while ensuring compliance with sponsor, regulatory, and company requirements.

Key responsibilities include:

• Managing site start-up activities from feasibility and qualification through activation.
• Building strong relationships with investigators and site staff.
• Preparing, reviewing, negotiating, and executing regulatory and site documents, including CDAs, ICFs, translations, and amendments.
• Coordinating submissions and approvals with IRBs/IECs, Ministries of Health, and Regulatory Authorities.
• Developing and tracking activation strategies, timelines, and regulatory plans.
• Maintaining high-quality documentation in CTMS, eTMF, and TMF systems, ensuring First Time Quality (FTQ).
• Identifying, resolving, or escalating site issues and risks related to activation, recruitment, compliance, training, and data quality.
• Supporting sites with study system access, training requirements, and readiness activities.
• Ensuring sites remain audit- and inspection-ready throughout the study lifecycle.
• Maintaining compliance with ICH-GCP guidelines, local regulations, sponsor requirements, and Parexel SOPs.
• Collaborating cross-functionally to achieve project milestones and deliverables while proactively communicating progress, risks, and issues.

Required Skills and Experience:

• Strong clinical research and study start-up experience.
• Excellent problem-solving, communication, presentation, and stakeholder management skills.
• Ability to work independently, prioritize multiple tasks, and make decisions in ambiguous situations.
• Strong knowledge of CTMS, eTMF, TMF, and Microsoft Office tools.
• Experience working in global, matrix, and multicultural environments.
• High attention to detail, quality focus, and commitment to achieving project timelines.
• Excellent English skills (oral and written).

Education: Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or another health-related field (or equivalent experience) is preferred.