Remote Lead Clinical Research Associate

Summary

Join PSI as a Lead CRA to coordinate investigator/site feasibility and identification process, monitor project timelines, and ensure data integrity and compliance.

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
• 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)

Responsibilities

• Coordinates investigator/ site feasibility and identification process
• Monitors project timelines and patient enrollment
• Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region
• Manages Monitors in the query resolution process, including Central Monitoring observations
• Coordinates safety information flow and protocol/process deviation reporting
• Performs clinical supplies management with vendors on a country and regional level
• Ensures study-specific and corporate tracking systems are updated in a timely manner
• Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager
• Coordinates planning of supervised monitoring visits and conducts the visits
• Manages the project team in site contracting and payments
• Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager
• Ensures ongoing evaluation of data integrity and compliance at a country/regional level
• Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level
• Oversees project team in CAPA development and implementation
• Coordinates project team in process deviations review, management and reporting
• Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs
• Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead
• Delivers trainings and presentations at Investigator Meetings
• Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits
• Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level
• Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations
• Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level
• Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level
• Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level
• Ensures data integrity and compliance at a site level
• Supervises 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 of site Investigators
• Supports preparation of draft regulatory and ethics committee submission packages