Clinical Research Associate

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

📋 Description

• Act as the primary CTI liaison for designated study sites.

• Conduct site visits including pre-study (PSV), site initiation (SIV), interim monitoring (IMV), and close-out (COV), ensuring that site visit deliverables meet quality standards and are completed within established timelines in accordance with the Monitoring Plan, while complying with all relevant regulatory requirements, SOPs, and ICH GCP.

• Assist with study initiation activities, encompassing feasibility assessments, pre-study tasks, and site selection.

• Gather, review, and monitor essential and regulatory documents.

• Engage in and fulfill all general and study-specific training as required.

• Participate in meetings with investigators, clients, and project teams.

• Develop and implement strategies for subject enrollment at assigned study sites.

• Ensure the appropriate storage, dispensation, and accountability of all Investigational Product (IP) and trial-related materials.

• Execute site management tasks and provide continuous updates on site status to the Clinical Project Manager.

• Conduct remote monitoring and carry out related activities in line with the study-specific Monitoring Plan.

• Utilize systems and reports to track subject status, subject case report form (CRF) retrieval/source document review (SDV), regulatory documents, and IP.

• Contribute to project-specific activities as a member of the Project Team.

• May assist in the development of CRFs and other study-related documents (such as subject worksheets and the Monitoring Plan).

• May aid in the translation, customization, and review of Patient Information sheets and Informed Consent, protocol synopses, and other relevant study documents following required protocols.

• Where applicable, provide support to the Regulatory Affairs Study Start-up Team in preparing or revising documentation for submission to Ethics Committees, Institutional Ethics Committees, Regulatory Authorities, Competent Authorities, or Institutional Administration Boards, and follow up on the evaluation process until approval is secured.

• Provide regular updates to the Sponsor/Client.

• Where applicable, assist in contract negotiations with study sites, manage Investigator payments, and track site payments.

• Manage the Investigator Site File (ISF) and Trial Master File (TMF) for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans.

• Identify site-related issues and implement corrective actions or escalate as needed.

• Collaborate with Clinical Data Management for data cleaning activities.

• Assist in preparing and coordinating Investigator and client meetings and attend these meetings as needed.

⛳️ Requirements

• Minimum of 2 years of clinical trial monitoring experience or equivalent experience as assessed by CTI Management and Human Resources.

• Proficient in English.

• Bachelor's Degree or higher in an allied health field, such as nursing, pharmacy, or health/natural sciences; or RN with an Associate's Degree; or a 3-year Nursing Diploma with at least 2 years of clinical nursing experience; or equivalent experience as determined by CTI Management and Human Resources.

• Prior experience in conducting clinical research studies within a hospital setting, pharmaceutical company, or CRO.

• Must be fully eligible to work in Argentina; CTI does not offer VISA sponsorship.

🏝️ Benefits

• Advance Your Career – We are committed to your professional development. Our structured mentoring program, leadership development courses, and dedicated training department provide the necessary support for you to thrive. We also promote ongoing education to help you reach your professional aspirations.

• Join an Award-Winning Team – Become part of a global team across 60 countries, celebrated for its award-winning culture that values people. We support your work-life balance through hybrid work opportunities. Through our CTI Cares program, you’ll find avenues to contribute to your community and the world.

• Make a Lasting Impact – At CTI, your contributions directly aid in the advancement of medicine. You will play a crucial role in the development of transformative treatments for patients with chronic and critical conditions. Together, we advance medicine, creating a meaningful difference for those in need.