Clinical Project Scientist
Company: Kelly Services
Posted on: September 24, 2022
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,
- Develops the medical review plan to support the statistical
- 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
- 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
- Participates in/leads interactions with health
- 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
- Ability to travel up to 10% required.
Keywords: Kelly Services, Philadelphia , Clinical Project Scientist, Healthcare , Philadelphia, Pennsylvania
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