Start up Research Associate (ICRA)

Parexel; United States; Remote; USD 70,000 - 110,000; Full time

Job summary

Parexel is expanding its Clinical Research Hub and seeks an Initiation Clinical Research Associate (iCRA) to join our team in Latin America—Brazil, Argentina, and Mexico. These are home-based roles offering flexible work from home with strong line-manager support and a connected team.

You will lead start-up activities, manage regulatory submissions, site activation, and protocol amendments from site identification through activation and maintenance.

Qualifications

• Strong clinical research and study start-up experience.
• Knowledge of CTMS and eTMF processes.
• Excellent oral and written English skills.

Responsibilities

• Manage site start-up activities from feasibility through site activation.
• Lead regulatory submissions and ensure readiness of regulatory documents.
• Coordinate with IRBs/IEC, ministries of health, and regulators.
• Develop activation strategies and regulatory plans to meet milestones.
• Maintain First Time Quality in documentation and systems.
• Identify and resolve activation, recruitment, and data quality risks.
• Provide site training and system access support.
• Ensure sites remain audit-ready and inspection-ready.
• Collaborate across functions to meet project milestones.
• Communicate progress, risks, and issues to stakeholders.

Skills

Clinical research

Study start-up

Regulatory submissions

MS Office

English proficiency

Education

Bachelor's degree in Life Sciences

Tools

CTMS

eTMF systems

Job description

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

At Parexel, we all share the same goal - to improve the world’s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we’re committed to making a difference.

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose - moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart®.

About the Role

We are expanding our Clinical Research Hub and adding Initiation Clinical Research Associate (iCRA) to join our team in Latin America – Brazil, Argentina and Mexico. These are home based roles where you have the flexibility that working from home offers but will be supported by dedication line managers and a strongly connected team. As an iCRA, you will lead and execute study start-up, pre-site initiation visit, site activation, and protocol amendment activities from site identification through activation and maintenance. Acting as the primary contact for assigned sites, you will manage regulatory submissions, site readiness, document quality, and activation timelines while ensuring compliance with sponsor, regulatory, and Parexel requirements.

You will join a fast-paced, growth-oriented environment where strong start-up delivery helps clinical studies begin efficiently and compliantly. Through close partnership with investigators, site staff, sponsors, and cross-functional colleagues, you will strengthen site readiness, protect document quality, and contribute directly to study milestones. The role offers opportunities to deepen your expertise across global study start-up and regulatory operations while influencing successful study activation.

Key Responsibilities

• Manage site start-up activities from feasibility and qualification through site activation.
• Build strong working relationships with investigators and site staff as the primary contact for assigned sites.
• Prepare, review, negotiate, and execute regulatory and site documents, including confidentiality disclosure agreements, informed consent forms, translations, and amendments.
• Coordinate submissions and approvals with Institutional Review Boards, Independent Ethics Committees, Ministries of Health, and Regulatory Authorities.
• Develop and track site activation strategies, timelines, and regulatory plans to support project milestones.
• Maintain accurate, high-quality documentation in clinical trial management, electronic trial master file, and trial master file systems, ensuring First Time Quality.
• Identify, resolve, or escalation site issues and risks related to activation, recruitment, compliance, training, and data quality.
• Support sites with study system access, training requirements, and readiness activities.
• Ensure assigned sites remain audit-ready and inspection-ready throughout the study lifecycle.
• Maintain compliance with International Council for Harmonization Good Clinical Practice guidelines, local regulations, sponsor requirements, and Parexel standard operating procedures.
• Collaborate across functions to achieve project milestones and deliverables, proactively communicating progress, risks, and issues.

Candidate Profile

You’ll thrive in this role if you bring:

• Strong clinical research and study start-up experience.
• Excellent problem-solving, communication, presentation, and stakeholder management skills.
• The ability to work independently, prioritize multiple tasks, and make sound decisions in ambiguous situations.
• Experience working in global, matrix, and multicultural environments.
• High attention to detail, a strong quality focus, and commitment to achieving project timelines.
• Confidence building productive relationships with investigators, site staff, and cross-functional partners.

Required Qualifications

• Strong clinical research and study start-up experience.
• Strong knowledge of clinical trial management systems, electronic trial master file systems, trial master file processes, and Microsoft Office tools.
• Knowledge of International Council for Harmonization Good Clinical Practice guidelines, local regulatory requirements, sponsor requirements, and clinical trial start-up processes.
• Excellent oral and written English skills.
• Strong communication, organization, presentation, stakeholder management, and problem-solving skills.

Preferred Qualifications

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

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.