Lead Clinical Research Associate

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

📋 Description

• Supervise and direct the clinical team while leading trial activities at a country or regional level.

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

• Evaluate monitoring visit reports and ensure adherence to regional reporting standards.

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

• Lead project team calls at the country level, providing status updates and reports.

• Deliver project-specific training and create training materials.

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

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

• Review essential study documents and oversee the reconciliation of ISF/TMF.

• Guarantee data integrity and compliance at the site level.

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

• Manage query resolution, including observations from Central Monitoring.

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

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

• Maintain updated study-specific and corporate tracking systems.

• Organize monitored visits and conduct site visits.

• Handle site contracting and payments.

• Prepare for audits, participate in site audits, and coordinate the resolution of findings.

• Oversee the development and implementation of CAPA.

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

• Conduct initial training and monitoring visits for Monitors.

• Mentor newly promoted Lead CRAs.

• Present training and information at Investigator Meetings.

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

• Ensure an efficient flow of information with trial sites concerning Adverse Events and protocol/process deviations.

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

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

⛳️ Requirements

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

• At least 4 years of site monitoring experience with involvement in global clinical projects as a Lead Monitor or an equivalent qualification.

• Experience in monitoring sites within the US.

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

• Strong preference for experience in Oncology.

• Preferred experience in Radiation Therapy, Radiopharmaceuticals, CAR-T Therapy, other Cell Therapies, Gene Therapy, or Nuclear Medicine.

• Preferred strong experience in GI (Crohn's, Ulcerative Colitis, IBS).

• Full working proficiency in English.

• Proficient in MS Office applications.

• Ability to plan, multitask, and thrive in a fast-paced team environment.

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

• Willingness to travel as needed.

• Must not require a work visa for employment or ongoing employment now or in the future.

🏝️ Benefits

• Option for remote work.

• Low-travel model.

• Confidential handling of applicant information in accordance with EEO guidelines.