Lead Clinical Research Associate

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

📋 Description

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

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

• Assess monitoring visit reports and ensure adherence to regional reporting requirements.

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

• Conduct country-level project team meetings and provide updates and reports on status.

• Deliver project-specific training and create training materials as needed.

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

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

• Review key study documents and supervise the reconciliation of Investigator Site Files and Trial Master Files (TMF).

• Guarantee data integrity and compliance at the site level.

• Assist with investigator/site feasibility assessments, identification, and study initiation.

• Supervise Monitors in resolving queries, including addressing Central Monitoring observations.

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

• Oversee clinical supplies in collaboration with vendors at both country and regional levels.

• Maintain study-specific and corporate tracking systems.

• Coordinate supervised monitoring visits and conduct assessments.

• Handle site contracting and payment processes.

• Evaluate data integrity and compliance at the country/regional level.

• Prepare for and engage in site audits, coordinating the resolution of findings.

• Supervise the development and implementation of Corrective and Preventive Actions (CAPA).

• Manage the review, oversight, and reporting of process deviations.

• Conduct initial training and authorization monitoring visits for Monitors.

• Mentor newly promoted Lead Clinical Research Associates (CRAs).

• Present training sessions and presentations at Investigator Meetings.

• Ensure that subject recruitment targets and project timelines are clearly defined, communicated, documented, and achieved.

• Guarantee timely information flow to trial sites regarding Adverse Events and protocol/process deviations.

• Oversee Site Management Associates in managing documents and laboratory supplies.

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

⛳️ Requirements

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

• A minimum of 4 years of experience in site monitoring.

• Involvement in global clinical projects as a Lead Monitor or equivalent role.

• Experience in monitoring sites based in the US.

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

• Strong background in Oncology is preferred.

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

• Robust experience in Gastrointestinal conditions, including Crohn's disease, Ulcerative Colitis, or IBS, is preferred.

• Full working proficiency in English.

• Proficiency in MS Office applications.

• Capability to plan and multitask within a dynamic team environment.

• Excellent skills in communication, collaboration, and problem-solving.

• Willingness to travel as required.

🏝️ Benefits

• Opportunity to work remotely.

• Career advancement opportunities.

• Chance to coordinate diverse tasks and acquire new skills.

• People-first company culture.