What are the responsibilities and job description for the Lead Clinical Research Associate position at PSI CRO?
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 studyspecific 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 projectspecific 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 projectspecific training of site Investigators.
Supports 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 CART 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 problemsolving skills.
Ability to travel up to 65% (depending on project needs).
Valid drivers license (if applicable).
Additional Information :
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.
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