Clinical Country & Site Associate – Clinical Trial Manager

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

📋 Description

• Conducts site qualification, initiation, interim monitoring, site management tasks, and close-out visits (either on-site or remotely) ensuring adherence to regulatory requirements, ICH-GCP, Good Pharmacoepidemiological Practices (GPP), and protocol compliance.

• Utilizes judgment and experience to assess the overall performance of the site and its staff, providing recommendations for site-specific actions; promptly communicates/escalates serious issues to the project team and collaborates to develop action plans.

• Maintains a comprehensive understanding of ICH/GCP Guidelines or other relevant guidance, applicable regulations, and company SOPs/processes.

• Confirms that the process of obtaining informed consent has been properly executed and documented for each subject/patient, as necessary.

• Exhibits diligence in safeguarding the confidentiality of each subject/patient.

• Evaluates factors that may influence the safety of subjects/patients and the integrity of clinical data at an investigator/physician site, including protocol deviations/violations and pharmacovigilance concerns.

• For the Clinical Monitoring/Site Management Plan (CMP/SMP): Evaluates site processes.

• Performs Source Document Review of relevant site source documents and medical records.

• Ensures that required clinical data entered in the case report form (CRF) is accurate and complete.

• Implements query resolution techniques both remotely and on-site, providing necessary guidance to site staff, and drives query resolution to completion within agreed timeframes.

• Leverages available hardware and software to facilitate the effective conduct of the clinical project data review and capture.

• Confirms site adherence to electronic data capture requirements.

• May conduct investigational product (IP) inventory, reconciliation, and review of storage and security.

• Verifies that the IP has been dispensed and administered to subjects/patients in accordance with the protocol.

• Assesses issues or risks related to blinded or randomized information concerning IP.

• Applies knowledge of GCP/local regulations and organizational processes to ensure IP is correctly (re)labelled, imported, and released/returned.

• Regularly audits the Investigator Site File (ISF) for accuracy, timeliness, and completeness.

• Reconciles the contents of the ISF with the Trial Master File (TMF).

• Ensures that the investigator/physician site understands the requirements for archiving essential documents in compliance with local guidelines and regulations.

• Records activities through confirmation letters, follow-up letters, trip reports, communication logs, and other necessary project documents in accordance with SOPs and the Clinical Monitoring Plan/Site Management Plan.

• Assists in subject/patient recruitment, retention, and awareness initiatives.

• Inputs data into tracking systems as needed to monitor all observations, ongoing status, and assigned action items until resolution.

• For assigned tasks, comprehends project scope, budgets, and timelines; oversees site-level activities/communication to ensure that project objectives, deliverables, and timelines are successfully achieved.

⛳️ Requirements

• Bachelor’s degree or RN in a related field or an equivalent combination of education, training, and experience.

• Familiarity with Good Clinical Practice/ICH Guidelines and other relevant regulatory requirements.

• Must possess strong computer skills and be open to adapting to new technologies.

• Exceptional communication, presentation, and interpersonal abilities.

• Willingness to manage required travel of up to 75% regularly.

🏝️ Benefits

• We are dedicated to developing our employees through career advancement and growth; providing supportive and engaged line management; offering technical and therapeutic area training; recognizing peers; and implementing a total rewards program.

• We are committed to fostering an inclusive culture where you can genuinely be yourself.