Clinical Research Associate – Site Director

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

📋 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 accordance with ICH-GCP guidelines, standard operating procedures, local laws and regulations, study protocol(s), and applicable study plans and working guidelines.

• Act as the main point of contact for clinical sites throughout all phases, from start-up to the close-out of clinical studies.

• Organize monitoring availability and ensure that data entry timelines are adhered to at assigned sites.

• Carry out necessary monitoring, including source data verification, and confirm that site activities are performed within set timelines.

• Build and nurture strong relationships with sites to ensure continuity in those relationships.

• Communicate with investigators and site personnel regarding issues related to protocol execution, recruitment, protocol deviations, inspection readiness, and overall site performance.

• Identify, evaluate, escalate, and address site performance or quality concerns promptly.

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

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

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

• Assist in site budget and contract negotiations, ensuring the timely finalization of necessary 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.

• Facilitate and support investigator site audits and/or inspection activities as required.

• Conduct remote data reviews and address queries for designated sites.

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

• Mentor and coach colleagues as necessary.

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

• May participate, as necessary, in other areas of study management and staff training.

• Perform additional duties as assigned.

⛳️ Requirements

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

• A Bachelor’s degree in nursing or an RN license is a plus.

• At least 3 years of direct site monitoring experience is required.

• Bilingual proficiency in English and French.

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

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

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

• Proficient in interpreting study level metrics data and proactively identifying and mitigating risks throughout the study lifecycle.

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

• Results-oriented with a proven ability to manage competing high-priority tasks while consistently meeting deliverables within established timelines.

• Excellent interpersonal skills and capability to work effectively in team environments.

• Ability to thrive in a dynamic setting with a high level of adaptability.

• Capacity to foster a culture of process improvement focused on streamlining processes to enhance company operations and meet business needs.

• Outstanding written and verbal communication skills.

• Prior experience and demonstrated expertise in CTMS and eTMF systems are preferred.

🏝️ 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.