Initiation Clinical Research Associate - iCRA
Primary Location: Brazil, Remote Additional Locations: Colombia, Remote; Mexico, Remote 求人ID R0000045120 Category Clinical Trials
About this Role
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.
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