PSI is a leading Contract Research Organization with over 30 years of experience in the industry, providing stability and innovation to clients and employees. The focus is on delivering quality and on-time services across various therapeutic indications.
Key Responsibilities:
Coordinates investigator/site feasibility and identification process, as well as study startup.
Monitors project timelines and patient enrollment, implements corrective and preventive measures.
Reviews monitoring visit reports and ensures reporting compliance.
Manages Monitors in query resolution process and safety information flow.
Coordinates clinical supplies management and ensures tracking systems are updated.
Acts as the main communication line between project team members.
Leads project team calls, evaluates data integrity, and conducts site audits.
Oversees CAPA development, process deviations review, and site audit findings resolution.
Conducts training, prepares materials, and delivers presentations.
Supervises data verification, ensures subject recruitment targets are met, and handles Investigational Products.
Reviews study documents, supervises reconciliation of Investigator Site File, and ensures data integrity.
Supervises flow of documents and laboratory supplies between sites and labs.
Conducts training of site Investigators and supports regulatory submission preparation.
Qualifications:
Relevant educational background in Life Sciences or equivalent.
Minimum of 4 years' site monitoring experience with global clinical projects.
Experience in US regulatory guidelines and practices.
Strong experience in Oncology, GI, and other therapies preferred.
Full working proficiency in English and MS Office applications.
Ability to plan, multitask, and work in a team environment.
Excellent communication, collaboration, and problem-solving skills.
Ability to travel up to 65% and valid driver's license if applicable.
Additional Information:
All information will be kept confidential according to EEO guidelines. PSI is not hiring individuals requiring work visas for employment.
