Clinical Research Associate I (CRA I) - São Paulo/SP

Job Description

Join Our Team as a Clinical Research Associate (CRA)!

Are you passionate about clinical research and committed to advancing healthcare? We are looking for a Clinical Research Associate (CRA) to support and manage clinical trial sites throughout all phases of the study lifecycle, ensuring compliance, data quality, and patient safety.

Key Responsibilities:

- Serve as the primary contact for assigned research sites throughout the clinical study lifecycle.
- Build and maintain strong relationships with investigators and site staff.
- Conduct remote and on-site monitoring activities in compliance with ICH-GCP, local regulations, protocols, and company procedures.
- Perform site visits, including site qualification, initiation, monitoring, and close-out visits.
- Review and maintain study and regulatory documentation throughout study start-up, maintenance, and close-out.
- Support site activation activities and collaborate with cross-functional teams to achieve Site Ready status.
- Ensure data quality, protocol compliance, and protection of participant rights, safety, and well-being.
- Identify and escalate site performance, quality, or compliance issues, driving appropriate corrective actions.
- Maintain accurate documentation and study information in clinical systems such as CTMS and eTMF.
- Support audit, inspection, and co-monitoring activities when required.

Main Requirements:

- Education:  Bachelor's degree in Life Sciences, Pharmacy, Nursing, Biology, Biomedicine, or related healthcare/scientific discipline. Other degrees may be considered with relevant healthcare experience.
- Experience:  Previous experience in clinical research, healthcare, site coordination, clinical operations, or related areas. Experience as a Clinical Trial Assistant (CTA), Research Coordinator, Research Nurse, or similar is highly valued.
- Languages:  Fluent Portuguese and advanced English (written and spoken).
- Knowledge of clinical research processes, GCP/ICH guidelines, and local regulatory requirements.
- Understanding of clinical trial monitoring, site management, and regulatory documentation.
- Experience or familiarity with clinical systems such as CTMS, eTMF, EDC, and MS Office applications.
- Strong organizational, communication, and stakeholder management skills.
- Ability to prioritize multiple tasks, work independently, and manage competing deadlines.
- Problem-solving mindset with the ability to identify root causes and support CAPA implementation.
- Ability to work effectively in a multicultural and matrix environment.
- Willingness to travel for on-site monitoring visits as required.

#ClinicalTrialsBR

Temos orgulho de ser uma empresa que acredita no valor de trazer pessoas de diferentes perfis, talentosas e comprometidas. A maneira mais rápida de revolucionar a inovação é quando ideias diversas se reúnem em um ambiente inclusivo. Incentivamos nossos colaboradores a abordar os problemas coletivamente e desafiar de forma respeitosa o raciocínio uns dos outros. Somos um empregador focado em promover iguais oportunidades aos nossos colaboradores, comprometido a incentivar um local de trabalho inclusivo e diversificad o.

Additional location(s) Compensation Information:

Required Skills:
Accountability, Accountability, Adverse Event Report, Clinical Evaluation Reports, Clinical Reporting, Clinical Research, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials Monitoring, Data Analysis, Data Monitoring, Document Management, Electronic Trial Master File, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Investigations Training, Key Stakeholder Relationships, On Site Monitoring, Protocol Adherence, Protocol Development, Regulatory Affairs Management, Regulatory Audits, Regulatory Compliance {+ 8 more}

Preferred Skills:

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Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:
Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:
10/29/2026
*A job posting is effective until 11:59:59PM on the day BEFORE  the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.