Job Overview
The ideal candidate will serve as a Lead Clinical Research Associate (CRA) responsible for ensuring the overall integrity of clinical trials in a designated region. Key responsibilities include coordinating investigator/site feasibility and identification processes, monitoring project timelines and patient enrollment, and managing monitors to ensure compliance with regulatory requirements.
Key Responsibilities:
* Coordinate investigator/site feasibility and identification process, including study startup.
* Monitor project timelines and patient enrollment, implement corrective and preventive measures as necessary.
* Review monitoring visit reports for all visit types and ensure reporting compliance of monitors in the region.
* Manage monitors in the query resolution process, including central monitoring observations.
* C Coordinate safety information flow and protocol/process deviation reporting.
* Perform clinical supplies management with vendors on a country and regional level.
* Ensure study-specific and corporate tracking systems are updated in a timely manner.
* Act as the main communication line between monitor, site management associate, regional project lead, and/or project manager.
* Coordinate planning of supervised monitoring visits and conduct the visits.
* Manage project team in site contracting and payments.
* Lead project team calls on a country level and provide status updates and reports to regional lead/project manager.
* Evaluate data integrity and compliance at a country/regional level.
* Conduct site audit preparation visits, participate in site audits, and coordinate resolution of site audit findings on a country/regional level.
* Oversight of CAPA development and implementation by project team.
* Coordinate process deviations review, management, and reporting.
* Provide initial training and authorization monitoring visits for monitors and act as mentor for newly promoted lead CRAs.
* Prepare and deliver trainings and presentations at investigator meetings.
* Prepare, conduct, and report site selection, initiation, routine monitoring, and closeout visits.
* Ensure subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level.
* Ensure accurate and timely information flow with trial sites on adverse events and protocol/process deviations.
* Supervise source data verification and follow up on data queries at site level in the country/region; review and manage study risks on a site level.
* Proper handling, use, accountability, reconciliation, and return of all investigational products and clinical study supplies on a country/region level.
* Review essential study documents and supervise reconciliation of study investigator site file (ISF)/TMF at site level and country/region level.
* Ensure data integrity and compliance at a site level.
* Supervise site management associates in the flow of documents and laboratory supplies between the site and the central/regional lab/Central Reviewer.
* Conduct project-specific training of site investigators.
* Support preparation of draft regulatory and ethics committee submission packages.
Qualifications:
* Relevant educational background, such as MD, MPharm, RN, or College/University degree in Life Sciences or an equivalent combination of education, training, and experience.
* Minimum of 5 years' site monitoring experience with participation in global clinical projects as a Lead Monitor.
* Experience with all types of monitoring visits in Phase II and/or III.
* Strong experience in Oncology preferred.
* Experience in CAR-T Therapy or other types of Cell Therapy, Gene Therapy, Radiation Therapy, or Radiopharmaceuticals, or Nuclear Medicine is preferred.
* Full working proficiency in English.
* Proficiency in MS Office applications.
* Ability to plan, multitask, and work in a dynamic team environment.
* Excellent Communication, collaboration, and problem-solving skills.
* Ability to travel up to 65% (depending on project needs).
* Valid driver's license (if applicable).
Additional Information: