Investigator Initiated Trial Study Scientist

Investigator Initiated Trial Study Scientist
  • $43 - $53 per Hour
    HOUR
  • Temporary
  • Morris Plains NJ, US Morris Plains Morris County US 07950
Job Ref: JO000106376
Sector: Science
Date Added: 02 October 2020


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.
SUPERVISORY RESPONSIBILITIES
none
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.

SRGTalent
02/11/2020 12:00:00
USD 43.00 43.00
Contact Consultant:
Jennifer Law

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