Canopy Life Sciences Argentina, Chile, Peru (Remote)
Canopy Life Sciences is a well-respected vendor & partner in the life sciences industry, assisting pharmaceutical and life sciences clients in various functional areas of expertise. We have been named for the past 4 years, to the Inc 5000 quickest growing private companies. Our culture is one of empowerment. Everyone has a voice and plays a role in the success of the business and a role in developing our values & behaviors. We recruit, train, and develop people to ensure the very best for our client partners.
Position Summary:
Department: Clinical Operations
Therapeutic Focus: Pulmonology
We are seeking a highly experienced Senior Clinical Research Associate (CRA) to support early-phase clinical development activities in the Pulmonology therapeutic area across Latin America. This part-time position (20 hours/week) is ideal for a seasoned professional who excels in site feasibility, qualification, and initiation, with evolving responsibilities throughout the study lifecycle, including aspects of patient enrollment, monitoring, and vendor collaboration. This role offers the opportunity to contribute meaningfully to innovative research, working cross-functionally with global teams and clinical sites in Argentina, Chile, or Peru.
Key Responsibilities:
- Lead and manage clinical site identification and feasibility assessments, ensuring alignment with protocol, timelines, and enrollment targets.
- Conduct site qualification and initiation visits, providing site training and supporting study start-up deliverables.
- Serve as the primary liaison with investigational sites, ensuring site preparedness and compliance with GCP, protocol requirements, and regional regulations.
- Support clinical teams in developing and executing patient identification, screening, and enrollment strategies.
- Maintain comprehensive and timely documentation of site activities, visit outcomes, and enrollment performance.
- Provide ongoing site support, including monitoring activities and performance evaluation through remote and on-site visits.
- Develop and maintain strong site relationships to support engagement, retention, and data quality.
- Collaborate with external vendors (e.g., central labs, imaging vendors, CROs) to ensure operational alignment, information flow, and resolution of region-specific site needs.
- Offer regional insights to support vendor feasibility and startup planning, while promoting effective communication and coordination throughout the study.
Qualifications:
- Advanced degree preferred (PharmD, PhD, MD) or Bachelor’s degree in Nursing (RN/BSN) or life sciences with significant CRA experience.
- Minimum of 5–7 years of relevant clinical research experience, with a strong foundation in early-phase feasibility and site start-up.
- Prior experience in Pulmonology clinical trials is strongly preferred.
- Comprehensive understanding of ICH-GCP, local regulatory guidelines, and clinical operations in Argentina, Chile, or Peru.
- Bilingual proficiency in Spanish and English required; Portuguese is a plus.
- Strong organizational and communication skills, with the ability to work independently in a matrixed, fast-paced environment.
- Familiarity with clinical systems (EDC, CTMS, eTMF) and site-facing technology platforms.
- Willingness to travel regionally as required (estimated 10–30%).