Senior CRA II – Site Care Partner

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

📋 Description

• Conducts site qualification, initiation, interim monitoring, management, and close-out visits (either on-site or remotely) to ensure adherence to regulatory standards, ICH-GCP, and/or Good Pharmacoepidemiology Practices (GPP) as well as protocol compliance.

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

• Maintains a thorough understanding of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.

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

• Exhibits diligence in safeguarding the confidentiality of all subjects/patients.

• Evaluates factors that could impact the safety of subjects/patients and the integrity of clinical data at investigator/physician sites, including protocol deviations/violations and pharmacovigilance concerns.

• Implements query resolution techniques both remotely and on-site, offering guidance to site staff as needed, and drives query resolution to completion within agreed timelines.

• Leverages available hardware and software to facilitate the efficient review and capture of clinical study data.

• Assesses issues or risks associated with blinded or randomized information pertaining to investigational products (IP).

⛳️ Requirements

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

• A minimum of 5-7 years of experience in clinical research monitoring, particularly in Oncology.

• Comprehensive knowledge of Good Clinical Practice/ICH Guidelines and other pertinent regulatory requirements.

• Proficiency in computer skills and a willingness to adopt new technologies.

• Outstanding communication, presentation, and interpersonal abilities.

• Expected to possess a moderate level of critical thinking skills.

• Must be able to manage regular travel requirements of up to 75%.

🏝️ Benefits

• We are dedicated to the development of our employees through career advancement opportunities, supportive and engaged management, technical and therapeutic training, peer recognition, and a comprehensive rewards program.

• We are focused on fostering an inclusive culture where you can genuinely be yourself. Our mission – Driven to Deliver – encapsulates the enthusiasm of our team to come together each day and create solutions that can significantly influence someone's life.

• We are continuously working towards building a company that we all aspire to work at and that our clients wish to partner with.