Luitpold Pharmaceuticals, Inc., a Daiichi Sankyo Group Company, is dedicated to the development and marketing of innovative, quality drugs and medical devices for healthcare professionals, clinics, and hospitals across the United States and Canada. We specialize in sterile injectables, as well as innovative products for veterinary medicine use.
Essential Duties and Responsibilities
Assist with Administration of clinical research projects: site and investigator recruitment, collecting investigator documentation, site management, site monitoring, preparing and maintaining proper status reports of activities at investigative sites through the duration of a clinical trial and completing other technical tasks to completion.
Qualify, initiate, monitor and close-out clinical investigative sites under supervision from Project Managers, Clinical Regulatory Managers, and Medical Directors.
Assist and manage training of new Clinical Research Associates.
Provide ongoing assistance and education of investigational sites in principles of Good Clinical Practice (GCP) as it relates to Research involving human and or animal subjects.
Ensure subject safety through diligent monitoring of the site’s compliance with study protocols and the collection of adverse event information
Update, track and maintain study specific trial management tools/system.
Monitor Case Report Forms (CRF) for missing implausible data. Assess compliance with investigational product handling procedures. Ensure that all adverse events are collected pursuant to GCP.
Report, write narratives and follow-up on reported serious adverse experiences.
Assist with generation and reconciliation of queries to investigation sites to resolve problem data.
Assist and manage project budget and investigator site budget as needed, attend project team meetings, plan, attend and participate in investigator meetings, and communicate with clients.
Generate and track investigational product shipments and storage.
Provide coverage to clinical contact telephone lines. Provide answers to common protocol related questions under the supervision of the Project Manager and Medical Director.
Qualifications and Requirements
Bachelor’s degree required. Preferred degree in the Biological / Health Sciences.
Pharmaceutical industry experience, clinical monitoring experience highly desired.
Ability to travel up to 80%, including overnight
Strong multi-tasking abilities and able successfully handle multiple priorities simultaneously.
Proficiency in MS Word, Excel and Outlook.
Detail oriented, self-motivated.
We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
##Job Category: Clinical/Medical Affairs/Pharmacovigilance##