Lead Clinical Research Associate

Summary

Join PSI, a leading Contract Research Organization, and contribute to the success of global clinical projects. Coordinate investigator/site feasibility, study startup, and monitoring processes. Manage project timelines, patient enrollment, and safety information flow. Oversee clinical supplies management, data integrity, and compliance. Lead project team calls, provide status updates, and conduct monitoring visits. Ensure accurate information flow with trial sites and supervise source data verification. This role requires strong communication, collaboration, and problem-solving skills, along with extensive experience in clinical monitoring.

Requirements

• 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
• 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)

Responsibilities

• Coordinate investigator/ site feasibility and identification process, as well as study startup
• Monitor project timelines and patient enrollment, implement respective corrective and preventive measures
• Review monitoring visit reports for all visit types and ensure reporting compliance of the Monitors in the region
• Manage Monitors in the query resolution process, including Central Monitoring observations
• 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/ Project Manager
• Coordinate planning of supervised monitoring visits and conduct the visits
• Manage the project team in site contracting and payments
• Lead project team calls on a country level as well as provide status updates and reports to Regional Lead/ Project Manager
• Ensure ongoing evaluation of data integrity and compliance at a country/regional level
• Conduct site audit preparation visits, may participate in site audits, and coordinate resolution of site audit findings on a country/regional level
• Oversee project team in CAPA development and implementation
• Coordinate project team in process deviations review, management and reporting
• Conduct initial training and authorization monitoring visits for Monitors and act as a mentor for newly promoted Lead CRAs
• Provide project-specific training and prepare training materials for the project team under supervision of a Project Manager and Regional Project Lead
• Deliver trainings and presentations at Investigator Meetings
• Prepare, conduct and report site selection, initiation, routine monitoring and closeout visits
• Ensure that 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
• Ensure proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) 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

Preferred Qualifications

• 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