Clinical Research Associate – Site Director

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

📋 Description

• Accountable for the effective initiation, oversight, and execution of Phase I-IV studies at designated clinical sites.

• Conduct clinical site management and monitoring tasks in adherence to ICH-GCP guidelines, SOPs, local laws, regulations, study protocols, applicable study plans, and operational guidelines.

• Act as the primary liaison for clinical sites throughout all phases from initiation to closure of clinical studies.

• Coordinate monitoring availability and ensure adherence to data entry timelines at the assigned sites.

• Execute necessary monitoring activities, including source data verification, and confirm that site operations are completed within the established timelines.

• Build and maintain robust relationships with site personnel to ensure continuity of those relationships.

• Communicate effectively with investigators and site staff regarding protocol execution, recruitment, protocol deviations, inspection readiness, and overall site performance.

• Identify, evaluate, escalate, and resolve issues related to site performance or quality in a timely manner.

• Complete feasibility assessments and site identification tasks for new clinical studies.

• Manage start-up and maintenance activities for assigned sites, including the preparation and gathering of essential documents required for regulatory and IRB/EC submissions (initial and amendments).

• Facilitate communication with relevant site personnel involved in start-up and IRB/EC submissions.

• Assist in site budget and contract negotiations, ensuring timely finalization of clinical trial agreements for designated sites in collaboration with clinical program management and finance.

• Responsible for developing site-specific recruitment, retention, and follow-up strategies.

• Support and facilitate investigator site audits and/or inspection activities as necessary.

• Conduct remote data review and resolve queries for designated sites.

• Enhance the overall knowledge of the clinical operations team by sharing best practices and engaging in improvement initiatives.

• Provide coaching and mentoring to colleagues as required.

• Participate in the evaluation of Codera’s systems and procedures as needed.

• May assist with other aspects of study management and staff training as required.

• Perform other assigned duties.

⛳️ Requirements

• Bachelor’s Degree in a Life Science discipline is mandatory.

• A Bachelor’s degree in nursing or an RN qualification is preferred.

• A minimum of 3 years of direct site monitoring experience is required.

• Bilingual proficiency in English and French is essential.

• Comprehensive understanding of all facets of clinical site monitoring and overall drug development is required.

• In-depth knowledge of FDA, ICH, GCP guidelines, and applicable local regulations is necessary.

• Exceptional critical thinking abilities and capacity to comprehend complex patient histories, medical terminology, and treatment landscapes.

• Aptitude for interpreting study-level metrics data and proactively identifying and mitigating risks throughout the study lifecycle.

• Detail-oriented, organized, and committed to maintaining quality and consistency.

• Results-oriented with the capability to manage multiple high-priority assignments, demonstrating a proven record of delivering results within specified timelines.

• Excellent interpersonal skills and ability to function effectively in team environments.

• Ability to thrive in a dynamic environment with considerable flexibility.

• Commitment to fostering a culture of process improvement with an emphasis on streamlining processes that add value to the business and its needs.

• Outstanding written and verbal communication skills.

• Experience and proven expertise in CTMS and eTMF systems is preferred.

• Must be willing and able to travel up to 50-65% of the time.

🏝️ Benefits

• Employer-sponsored insurance plans, including medical, dental, and vision coverage.

• Generous paid time off.

• Retirement plan options available.

• Additional wellness and professional development programs offered.