Lead Clinical Research Associate

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

📋 Description

• Facilitates the feasibility assessment and site identification process for investigators, as well as initiating studies.

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

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

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

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

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

• Guarantees timely updates to study-specific and corporate tracking systems.

• Serves as the principal communication liaison among the Monitor, Site Management Associate, Regional Project Lead, and/or Project Manager.

• Plans and coordinates supervised monitoring visits, and conducts the visits as needed.

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

• Leads project team discussions 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 them, and coordinates the resolution of audit findings at the country/regional level.

• Guides the project team in developing and implementing CAPAs.

• Coordinates the project team's review, management, and reporting of process deviations.

• Conducts initial training and authorization monitoring visits for Monitors and mentors newly promoted Lead CRAs.

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

• Provides training and presentations during Investigator Meetings.

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

• Ensures that subject recruitment goals and project timelines are clearly defined, communicated, documented, and achieved at the site level.

• Guarantees accurate and prompt communication with trial sites regarding Adverse Events and protocol/process deviations.

• Supervises source data verification and addresses data queries at the site level within the country/region; evaluates and manages study risks on a site level.

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

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

• Ensures data integrity and compliance at the site level.

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

• Conducts project-specific training for site Investigators.

• Aids in preparing draft 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 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 level.

• Must possess 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.

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

• Significant experience in GI conditions (Crohn's, Ulcerative Colitis, IBS) is preferred.

• Full working proficiency in English.

• Competence in MS Office applications.

• Capability to plan, multitask, and work effectively in a dynamic team environment.

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

• Willingness to travel up to 65% (depending on project requirements).

• A valid driver’s license (if applicable).

🏝️ Benefits

• Propel your career in clinical research by coordinating diverse tasks and acquiring new skills while advancing with a rapidly growing company that prioritizes its people.