Lead Clinical Research Associate

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

📋 Description

• Lead and support the clinical team while overseeing trial activities at the country or regional level.

• Track project timelines, patient enrollment, data management, compliance, and implement corrective and preventive actions.

• Evaluate monitoring visit reports and ensure compliance with reporting standards across the region.

• Facilitate communication among Monitors, Site Management Associates, Regional Project Leads, and Project Managers.

• Conduct country-level project team calls and provide updates and reports on progress.

• Deliver project-specific training and develop training materials.

• Oversee source data verification, follow up on data queries, and manage site-level study risks.

• Ensure appropriate handling, accountability, reconciliation, and return of investigational products and clinical study supplies.

• Review essential study documents and manage ISF/TMF reconciliation.

• Guarantee site-level data integrity and compliance.

• Collaborate on investigator/site feasibility assessments, identification, and study initiation.

• Manage query resolution, including observations from Central Monitoring.

• Oversee the flow of safety information and reporting of protocol/process deviations.

• Coordinate clinical supplies management with vendors at both country and regional levels.

• Maintain tracking systems specific to the study and corporate requirements.

• Organize and conduct supervised monitoring visits.

• Handle site contracting and payment processes.

• Prepare for audits by conducting site visits, participating in audits, and addressing findings.

• Supervise the development and implementation of CAPA.

• Manage process deviation reviews, oversight, and reporting.

• Conduct initial training and monitoring visits for Monitors.

• Mentor newly promoted Lead CRAs.

• Provide training and presentations at Investigator Meetings.

• Ensure that subject recruitment targets and project timelines are defined, communicated, and met.

• Ensure timely communication with trial sites regarding Adverse Events and protocol/process deviations.

• Supervise Site Management Associates in the handling of documents and laboratory supplies.

• Assist in the preparation of submission packages for regulatory and ethics committees.

⛳️ Requirements

• Relevant educational qualifications such as MD, MPharm, RN, or a degree in Life Sciences, or a comparable combination of education, training, and experience.

• At least 4 years of experience in site monitoring.

• Involvement in global clinical projects as a Lead Monitor or an equivalent level of qualification.

• Experience in monitoring sites within the US.

• Familiarity with all types of monitoring visits in Phase II and/or III.

• Strong experience in Oncology is preferred.

• Background in Radiation Therapy, Radiopharmaceuticals, CAR-T Therapy, other Cell Therapies, Gene Therapy, or Nuclear Medicine is preferred.

• Significant experience in Gastroenterology, particularly with conditions like Crohn's, Ulcerative Colitis, or IBS, preferred.

• Full proficiency in English.

• Competence in MS Office applications.

• Ability to plan and multitask effectively in a dynamic team setting.

• Exceptional communication, collaboration, and problem-solving abilities.

• Willingness to travel.

🏝️ Benefits

• Remote work options.

• Opportunities for career advancement.

• Continuous learning and growth alongside the company.