Initiation Clinical Research Associate - iCRA

Parexel; Brasil; Presencial; BRL 120 000 - 200 000; Tempo integral

Resumo da oferta

Parexel seeks an experienced Initiation Clinical Research Associate (iCRA) in Brazil to lead start-up activities from site identification to activation and maintenance. You will manage regulatory submissions, site readiness, and activation timelines while ensuring compliance with sponsor and Parexel requirements.

You will build strong relationships with investigators, coordinate IRB/IEC submissions, and maintain documentation in CTMS/eTMF/TMF systems to support timely, compliant trial delivery.

Qualificações

• 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 in global, matrix, and multicultural environments.
• High attention to detail and commitment to timelines.
• Excellent English skills (oral and written).
• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field preferred.

Responsabilidades

• Lead and manage site start-up activities from feasibility through activation.
• Build strong relationships with investigators and site staff.
• Prepare, review, and execute regulatory and site documents.
• Coordinate submissions with IRBs/IECs and regulatory authorities.
• Develop activation timelines and regulatory plans.
• Maintain high-quality documentation in CTMS/eTMF/TMF.
• Identify and resolve site issues affecting activation and data quality.
• Support site training and system access needs.
• Ensure audit-ready readiness throughout study lifecycle.
• Ensure compliance with ICH-GCP and Parexel SOPs.
• Collaborate cross-functionally to meet milestones.

Conhecimentos

Clinical research

Study start-up

CTMS/eTMF/TMF

Stakeholder management

Communication

MS Office

Multicultural teams

English proficiency

Formação académica

Bachelor's degree in Life Sciences/Pharmacy/Nursing

Ferramentas

CTMS

eTMF

TMF

Microsoft Office

Descrição da oferta de emprego

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.