Lead Clinical Research Associate at PSI CRO

United States

<h3>Company Description</h3><p>PSI is a leading Contract Research Organization with more than 25 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.</p><ul></ul><h3>Job Description</h3><ul><li>Coordinates investigator/ site feasibility and identification process, as well as study startup.</li><li>Monitors project timelines and patient enrollment, implements respective corrective and preventive measures.</li><li>Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region.</li><li>Manages Monitors in the query resolution process, including Central Monitoring observations.</li><li>Coordinates safety information flow and protocol/process deviation reporting.</li><li>Performs clinical supplies management with vendors on a country and regional level.</li><li>Ensures study-specific and corporate tracking systems are updated in a timely manner.</li><li>Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager.</li><li>Coordinates planning of supervised monitoring visits and conducts the visits. </li><li>Manages the project team in site contracting and payments.</li><li>Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager.</li><li>Ensures ongoing evaluation of data integrity and compliance at a country/regional level.</li><li>Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level.</li><li>Oversees project team in CAPA development and implementation.</li><li>Coordinates project team in process deviations review, management and reporting.</li><li>Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs.</li><li>Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead.</li><li>Delivers trainings and presentations at Investigator Meetings.</li><li>Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits.</li><li>Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level.</li><li>Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations.</li><li>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.</li><li>Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level.</li><li>Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level.</li><li>Ensures data integrity and compliance at a site level.</li><li>Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer.</li><li>Conducts project-specific training of site Investigators.</li><li>Supports preparation of draft regulatory and ethics committee submission packages.</li></ul><h3>Qualifications</h3><ul><li>Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience.</li><li>Minimum of 4 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level. </li><li>Experience with all types of monitoring visits in Phase II and/or III.</li><li>Strong experience in Oncology preferred.</li><li>Experience in CAR-T Therapy or other types of Cell Therapy, Gene Therapy, Radiation Therapy or Radiopharmaceuticals, or Nuclear Medicine is preferred. </li><li>Strong experience in GI (Chron's, Ulcerative Colitis, IBS) preferred. </li><li>Full working proficiency in English.</li><li>Proficiency in MS Office applications.</li><li>Ability to plan, multitask and work in a dynamic team environment.</li><li>Excellent Communication, collaboration, and problem-solving skills.</li><li>Ability to travel up to 50% (depending on project needs).</li><li>Valid driver’s license (if applicable).</li></ul><h3>Additional Information</h3><p>If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.</p><p>For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.</p>