Investigator Initiated Trial Study Scientist
GENERAL SUMMARY (FUNDAMENTAL PURPOSE OF THE POSITION)
• Serves as a Medical Affairs Trial Lead. Responsible for tracking, coordinating, and execution of assigned medical affairs trial activities; May serve as primary contact for assigned site-facing study activities and questions.
ESSENTIAL JOB FUNCTIONS* (PRIMARY RESPONSIBILITIES)
• Ensures that study objectives and timelines are met. Collaborates with internal stakeholders for drug supply, study documents and meetings. Serve as the liaison between Immunomedics and Investigational sites to complete / resolve requests to continue patient enrollment.
CORE COMPETENCIES (KNOWLEDGE, SKILLS, AND ABILITIES)
• Assist in the execution of trial level startup / ongoing / close-out activities for multiple investigator initiated trials.
• Track drug supply lots and shipments to sites.
• Consult with internal Medical Affairs partners as needed including: Medical Information, Medical Communications, Biostatistics, Legal, Commercial, Medical Team, Quality Assurance, Supply Chain, Pharmacovigilance, Medical Science Liaisons, Regulatory Affairs, Pre-Clinical, laboratories and other external vendors/collaborators
• Be the internal liaison and track the review of documents such as: clinical protocols, consents, amendments, IND annual reports, Investigator Brochures and other clinical documents as needed.
• Communicate with study sites to provide safety data for pharmacovigilance as needed.
• Ensure the timely tracking and return of feedback within abstract/publication timelines.
• Supports company compliance with SOPs and assists in updates as needed.
EDUCATION/ EXPERIENCE (MUST INCLUDE MINIMUM REQUIREMENTS NECESSARY TO PERFORM ESSENTIAL JOB FUNCTIONS; ADDITIONAL PREFERENCES OPTIONAL)
• BS/MS within Scientific, Project Management or Business discipline required
• Clinical experience / oncology work experience preferred
• Excellent verbal and written communication skills, ability to negotiate, resolve conflicts, prioritize, organize, and work in a matrixed team environment
• Proficient knowledge of GCP/ICH and drug development process
• Flexible to support multiple demands with professionalism
• Proficient planning and time management skills to support multiple demands
• Knowledge and utilization of PowerPoint, Microsoft Teams, SharePoint and Excel
PHYSICAL REQUIREMENTS AND WORKING CONDITIONS
• Environment: Standard office setting; exposure to computer screens.
• Physical: Primary functions require sufficient physical ability to work in an office setting and operate standard office equipment including use of a computer keyboard. Sedentary work, which includes exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently to move objects. Involves sitting most of the time, but may include walking or standing for brief periods of time.
• Vision: See in the normal visual range with or without correction; vision sufficient to read computer screens and printed documents.
• Hearing: Hear in the normal audio range with or without correction.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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