Initiation Clinical Research Associate - iCRA
Primary Location: Brazil, Remote Additional Locations: Colombia, Remote; Mexico, Remote Job ID R0000045120 Category Clinical Trials Date Posted 08/25/2026Overview
As a Clinical Research Associate (CRA) at Parexel, you act as an integral part to get treatments to patients sooner. Our CRAs' priority is the safety and well-being of the patients. As you travel to investigator sites and perform your monitoring duties, we encourage you to be inquisitive, take accountability, build relationships, and act with integrity.
Join a team with a wide variety of experiences and knowledge, and work on global projects within a broad scope of therapeutic areas. We’re looking for people who want to grow personally and professionally and support their colleagues globally and cross-functionally.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Flexible
- Organized
- Problem-solver
- Self-starter
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.
#LI-REMOTE
Potential Career Path
Parexel offers various career paths and internal development programs for CRAs to advance to the next level. This could include enhancing your technical position, moving into management, or shifting to other areas of the business.
- APEX CRA
- CRA I
- CRA II
- Senior CRA
- Project ManagementSubject Matter ExpertPeople Management
Employee Insights
TEAM IMPRESSIONS
Why Clinical Research Associates work at Parexel
