Lead Clinical Research Associate

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

📋 Description

• Facilitates the investigator/site feasibility and identification process, along with study initiation.

• Tracks project timelines and patient enrollment, implementing necessary corrective and preventive actions.

• Evaluates monitoring visit reports for all types of visits and ensures compliance in reporting by Monitors within the region.

• Oversees Monitors in the process of query resolution, including observations from Central Monitoring.

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

• Conducts management of clinical supplies with vendors on both country and regional levels.

• Ensures that study-specific and corporate tracking systems are updated promptly.

• Acts as the primary communication channel among Monitor, Site Management Associate, Regional Project Lead, and Project Manager.

• Plans and coordinates supervised monitoring visits and carries out these visits.

• Directs the project team in site contracting and payment activities.

• Leads project team meetings at the country level and provides updates and reports to the Regional Lead/Project Manager.

• Ensures continuous evaluation of data integrity and compliance at the country/regional level.

• Prepares for site audits, may participate in the audits, and coordinates the resolution of audit findings at the country/regional level.

• Guides the project team in the development and implementation of CAPA.

• Coordinates the project team in reviewing, managing, and reporting process deviations.

• Conducts initial training and authorization monitoring visits for Monitors and serves as a mentor for newly promoted Lead CRAs.

• Provides project-specific training and develops training materials for the project team under the guidance of a Project Manager and Regional Project Lead.

• Delivers training sessions and presentations at Investigator Meetings.

• Prepares, conducts, and reports on site selection, initiation, routine monitoring, and closeout visits.

• Ensures that subject recruitment goals and project timelines are well-defined, communicated, recorded, and achieved at the site level.

• Guarantees accurate and timely information flow with trial sites regarding Adverse Events and protocol/process deviations.

• Supervises source data verification and follows up on data queries at the site level within the country/region; reviews and manages study risks at the site level.

• Ensures the proper handling, use, accountability, reconciliation, and return of all Investigational Products and clinical study supplies at the country/region level.

• Reviews essential study documents and supervises the reconciliation of the Investigator Site File (ISF)/TMF at the site and country/region levels.

• Maintains data integrity and compliance at the site level.

• Oversees Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/Regional Lab/Central Reviewer.

• Conducts project-specific training for site Investigators.

• Assists in preparing draft regulatory and ethics committee submission packages.

⛳️ Requirements

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

• A minimum of 4 years’ site monitoring experience with involvement in global clinical projects as a Lead Monitor or equivalent qualification level.

• Prior experience in monitoring or managing sites and CRAs in the United States, with a solid understanding of US regulatory guidelines and practices.

• Experience with all types of monitoring visits in Phases I-III.

• Strong experience in Oncology is preferred.

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

• Strong experience in GI conditions (Chron’s, Ulcerative Colitis, IBS) is preferred.

• Full working proficiency in English.

• Proficiency in MS Office applications.

• Ability to plan, multitask, and thrive in a dynamic team environment.

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

• Willingness to travel up to 65% based on project needs.

🏝️ Benefits

• Advance your career in clinical research.

• Engaging work environment.

• Opportunities for professional growth.