Clinical Research Associate II
New
J
JobgetherClinical Research
Remote position based in BrazilFull-TimeMiddle
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- At least 2 years of relevant clinical operations experience, including a minimum of 1 year of clinical monitoring experience.
- Required Skills
- Microsoft Office
Requirements
- Bachelor’s degree in a relevant scientific discipline or equivalent academic background.
- At least 2 years of relevant clinical operations experience, including a minimum of 1 year of clinical monitoring experience.
- Thorough understanding of clinical trial processes, ICH-GCP principles, and applicable regulatory requirements.
- Experience conducting site monitoring visits and managing investigative sites.
- Strong understanding of protocol compliance, data quality, patient safety, and clinical documentation requirements.
- Fluency in English (written and verbal).
- Strong interpersonal and relationship-building skills.
- Excellent organizational and prioritization skills.
- Ability to work independently and contribute to a global, cross-functional team.
- Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.
- Familiarity with clinical trial management systems (CTMS) and clinical data management systems.
- Ability and willingness to travel extensively, with up to 70% travel required.
Responsibilities
- Perform and coordinate assigned clinical monitoring activities in accordance with ICH-GCP guidelines, regulations, and SOPs.
- Conduct site visits, including pre-study site visits, site initiation visits, interim monitoring visits, and close-out visits.
- Maintain effective communication and collaborative relationships with investigators and key site personnel.
- Assess protocol compliance, regulatory adherence, patient safety, and data quality during monitoring activities.
- Prepare accurate and timely monitoring reports and other required clinical documentation.
- Monitor site performance by tracking enrollment, Case Report Form (CRF) data entry, and protocol deviations.
- Perform Serious Adverse Event (SAE) reconciliation and collaborate with sites to resolve discrepancies.
- Assist clinical sites with audit and inspection preparation and address identified quality issues.
- Mentor and support less experienced CRAs on general and study-specific monitoring topics.
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