Location: Brazil (remote)
Type: 12-month contract - attractive hourly compensation.
About Clinergy
Clinergy Health is a boutique CRO focused on delivering high-quality, highly tailored clinical development solutions for pharmaceutical and biotech companies.
We intentionally work with a small number of strategic projects, spanning Phase I to Real-World Evidence, to ensure scientific rigor, operational excellence, and true partnership with our clients.
Role Description
We are looking for a Contract Clinical Research Associate. The Clinical Research Associate will oversee and monitor assigned clinical trials, ensuring compliance with protocols and regulatory requirements. Key responsibilities may include site assessment selection, initiation, and management, coordinating clinical operations, assisting with protocol implementation, and ensuring accurate study documentation. The role involves frequent collaboration with cross-functional teams and adherence to quality standards to meet project timelines.
Activities
* Support and conduct preparation activities for Site Initiation Visits;
* Conduct independent monitoring to verify accuracy of study data vs. source records;
* Ensure requirements for patient privacy are met;
* Generate and collect study documentation such as consent forms, Essential Documents, Case Report Forms and Investigator Agreements;
* Conduct and tracks progress of site activities to initiation, enrolment and screening, interim monitoring and close out requirements;
* Ensure no study tasks are conducted prior to IRB/EC approval and formal site activation;
* Review Serious Adverse Event (SAE) narratives with sites and medical monitor; Ensure adverse event reporting is done in accordance with regulatory requirements;
* Organize, conduct and report on Site Qualification, Site Initiation, Interim Monitoring, and Close-out visits;
* Verify the accuracy of study results;
* Identify and resolve site issues;
Requirements
* Bachelor’s degree in life sciences;
* 2+ years experience as a CRA on pharma or CRO companies(Mandatory);
* Advanced/Fluent in English;
* Strong medical and clinical knowledge of indications, therapies, and patient population
* Proven track record of having good sponsor, investigator, site, and vendor relations
* Strong computer skills including EDC system experience
* Demonstrated detailed knowledge of guidelines, systems for clinical trial management and of ICH GCP and international regulations and practices
Skills
* Self driven individual
* Sense of urgency
* Excellent interpersonal, verbal, and written communication skills
* Attention to detail and strong organizational skills
* Good problem solving skills
* Enthusiastic and energetic
To apply for this opportunity please send your updated CV to
Note: Candidates who do not possess the mandatory requirements specified above will not be considered.