Clinical Project Scientist

Company: Kelly Services
Location: Philadelphia
Posted on: September 24, 2022

Job Description:

Clinical Project Scientist (Remote)Summary:The Clinical Project Scientist is responsible for the design, planning, implementation, monitoring, and reporting of clinical research trials

• Partners with Study Responsible Physician (SRP) to provide clinical oversight to the study;
• Develops clinical research protocols, study case report forms, informed consent;
• Develops the medical review plan to support the statistical analysis plan;
• Plays a key role in the medical review of the study data and assists in coding, analysis and documentation
• Validates and interprets results of phase I - IV investigations in preparing new drug applications to the appropriate health authorities, scientific congresses, and peer-reviewed journals
• Ensures team member adherence to clinical research guidelines and safety procedures;
• Communicates detailed outcomes and results of research findings to relevant partners;
• Provides input in managing project budgets and projections;
• Serves as liaison to global clinical sites for medical questions related to the clinical research trial ;
• Presents study status at internal/external meetings, including investigator meetings and governance committees
• Trains and mentors local/central study teams and investigative sites on the study protocol, ensuring they have the necessary guidance and tools for performance of various project activities
• Participates in/leads interactions with health authorities;
• Maintains expertise on clinical trial documentation, requirements, regulations, operational procedures, study file requirements, regulatory requirements, policies;
• Reviews and maintains correct standard operations, procedures and protocol Education and Experience Requirements:
  • A minimum of a bachelor's degree is required; and advanced degree is preferred.
  • A minimum of 3 years of clinical research and development, or related experience within the industry (pharmaceutical, biotech, CRO, etc) is required.
  • Experience in oncology therapeutic area is preferred.
  • Significant experience with clinical trials including development of protocols, case report forms, informed consent and study initiation and monitoring preferred.
  • Excellent written communication, oral communication, and presentation skills are required.
  • The individual must have demonstrated ability to work in a team environment.
  • Ability to travel up to 10% required.

Keywords: Kelly Services, Philadelphia , Clinical Project Scientist, Healthcare , Philadelphia, Pennsylvania