Lead Clinical Research Associate

PSI CRO

4d • Onsite

About The Position

PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

This role involves coordinating investigator/site feasibility and identification, study startup, and monitoring project timelines and patient enrollment. The Lead CRA will implement corrective and preventive measures, review monitoring visit reports, manage query resolution, and coordinate safety information flow. They will also perform clinical supplies management, ensure tracking systems are updated, and act as a communication line between various project team members. The position includes coordinating supervised monitoring visits, managing site contracting and payments, leading project team calls, and ensuring data integrity and compliance. Additionally, the role involves overseeing audit preparation, CAPA development, process deviation management, and providing training to Monitors and newly promoted Lead CRAs. The Lead CRA will also deliver trainings at Investigator Meetings, prepare and conduct various site visits, ensure recruitment targets and timelines are met, and supervise source data verification. They will oversee the handling of Investigational Product and clinical study supplies, review essential study documents, and supervise the reconciliation of study files. The role also supports regulatory and ethics committee submissions.

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 4 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level.
• Must have prior experience monitoring or managing sites and CRAs with knowledge of US and Canadian regulatory guidelines and practices.
• Experience with all types of monitoring visits in Phases I-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).

Nice To Haves

• 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.
• Strong experience in GI (Chron's, Ulcerative Colitis, IBS) preferred.

Responsibilities

• Coordinates investigator/site feasibility and identification process, as well as study startup.
• Monitors project timelines and patient enrollment, implements respective corrective and preventive measures.
• 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.

Benefits

• Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with a rapid growing company that puts its people first.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree