Clinical Research Associate Lead
Vor 6 Tagen
Job Summary
PSI is seeking a highly skilled and experienced Lead Clinical Research Associate to join our team. As a key member of our clinical operations team, you will be responsible for overseeing the coordination and execution of clinical trials, ensuring compliance with regulatory requirements, and providing guidance to junior team members.
Key Responsibilities
- Coordinate investigator/site feasibility and identification process, as well as study startup.
- Monitor project timelines and patient enrollment, implementing corrective and preventive measures as needed.
- Review monitoring visit reports for all visit types and ensure reporting compliance.
- Manage 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 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.
- Ensure ongoing evaluation of 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.
- 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.
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).
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