Job Title:
Clinical Research Associate II (CRA II) – Sponsor Dedicated
Location:
Brazil – Home-Based (Remote)
Job ID:
25102362
Updated: Yesterday
About Syneos Health®
Syneos Health is a leading fully integrated biopharmaceutical solutions organization, dedicated to accelerating customer success. With a presence in over 110 countries and a workforce of 29,000 employees, we combine clinical, medical affairs, and commercial expertise to transform insights into outcomes and deliver innovative healthcare solutions.
Work Here Matters Everywhere.
Why Join Us
Career Growth & Development: Continuous learning, progression, and mentorship.
Supportive Culture: Engaged line management and peer recognition programs.
Inclusive Environment: “Total Self” culture encourages authenticity and belonging.
Diversity & Collaboration: Multicultural teams where every voice matters.
Key Responsibilities
Conduct site qualification, initiation, monitoring, and close-out visits (on-site or remote).
Ensure compliance with ICH-GCP, GPP, local regulations, and study protocols.
Evaluate site performance, provide feedback, and escalate serious issues promptly.
Verify and document informed consent and maintain subject confidentiality.
Assess and mitigate protocol deviations, violations, or PV issues.
Conduct Source Document Reviews (SDR) and ensure accuracy of CRF data.
Drive query resolution with site staff within agreed timelines.
Review investigational product (IP) storage, dispensing, and reconciliation per protocol.
Reconcile Investigator Site File (ISF) with Trial Master File (TMF) for completeness.
Support subject recruitment and retention strategies.
Maintain documentation through confirmation letters, trip reports, and logs.
Track site performance metrics and manage site-level budgets, timelines, and deliverables.
Liaise with study site personnel and ensure training compliance for site teams.
Participate in investigator meetings, sponsor meetings, and clinical training sessions.
Prepare for and support audit readiness and inspection follow-up.
Additional Responsibilities (Real World Late Phase Studies)
Support sites from identification to close-out.
Perform chart abstraction and data collection.
Collaborate with sponsor affiliates, medical science liaisons, and local staff.
Suggest potential sites using knowledge of treatment patterns and HCP associations.
Train junior staff as needed and flag out-of-scope activities to Leads/PMs.
Qualifications
Education:
Bachelor’s degree in a related field or RN qualification (or equivalent experience).
Knowledge:
Strong understanding of ICH-GCP and local regulatory guidelines.
Familiarity with clinical trial monitoring processes.
Skills:
Excellent communication, presentation, and interpersonal skills.
Proficiency in computer systems and EDC platforms.
Ability to adapt to new technologies.
Other Requirements:
Willingness to travel up to 75% as needed.
For U.S. sites, compliance with facility medical and access requirements is mandatory.
About the Role
This role focuses on ensuring the integrity and quality of clinical research data through on-site and remote monitoring. The CRA II applies risk-based monitoring techniques and data analytics to identify trends, verify compliance, and enhance trial quality.
Impact & Contribution
Acts as an individual contributor or manages a small team.
Responsible for defined project components, using expertise to design, implement, or optimize monitoring processes.
Ensures adherence to timelines, SOPs, and regulatory expectations.
About Syneos Health (Quick Facts)
Worked on 94% of FDA-approved drugs and 95% of EMA-authorized products in the last 5 years.
Partnered on 200+ studies, covering 73,000 sites and 675,000+ trial patients globally.
Visit: www.syneoshealth.com
Equal Opportunity & Accessibility
Syneos Health is committed to diversity and inclusion. Applicants with diverse backgrounds and transferable skills are encouraged to apply.
Reasonable accommodations will be provided under the Americans with Disabilities Act (ADA) when necessary.
Summary
|
Category |
Details |
|---|---|
|
Role Type |
Clinical Monitoring / CRA |
|
Level |
CRA II (Individual Contributor) |
|
Work Mode |
Home-Based (Brazil) |
|
Key Focus |
Site monitoring, compliance, data accuracy |
|
Travel |
Up to 75% |
|
Employer |
Syneos Health |
|
Website |
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Netherlands |Remote Australia :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Australia | North York | Mississauga | Richmond Hill | Uxbridge | Renfrew |Canada :
Canada |Quebec :
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Brussels |Antwerp :
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Zaventem |South America :
Peru | Argentina |Brazil :
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Auckland |New Zealand :
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Manila |Croatia :
Croatia |Zagreb :
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