In-house Clinical Research Associate II

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Assist in the collection of feasibility questionnaires and Confidential Disclosure Agreements (CDA) from prospective sites, as needed.

• Organize the shipment and receipt of study materials (such as Case Report Forms (CRFs) and manuals) to and from study sites.

• Provide necessary updates for site-related documentation for inclusion in the Trial Master File (TMF) and review collected documents for quality in compliance with Good Documentation Practice (GDP) and Worldwide Clinical Trials Standard Operating Procedures (SOPs) prior to their submission to the TMF.

• Support field Clinical Research Associates (CRA) in maintaining the Investigator Site File (ISF) by assisting with the reconciliation of the Trial Master File (TMF) and offering assistance with the TMF Quality Control Checklist (QCCL).

• Discuss and aid field CRA and/or site personnel with the management of Investigational Product (IP) inventory, where applicable.

• Maintain ongoing communication with sites as outlined in the Clinical Monitoring Plan and Site Management and Monitoring Plan, as necessary.

⛳️ Requirements

• A minimum of a four-year college degree with a major focus in medical, biological, physical, health, pharmacy, or another related science.

• At least two years of experience in clinical research (e.g., study coordinator, research nurse).

• One year of experience as an In-house Clinical Research Associate.

• A two-year college degree or equivalent education/training, along with a minimum of three years of clinical research experience (e.g., study coordinator, research nurse) OR two years of experience as an In-house Clinical Research Associate.

• Proficient in the local languages of the countries under responsibility and possess strong spoken and written English skills.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible work hours

• Paid time off

• Professional development opportunities