Clinical Scientist - Level Dependent Upon Experience - Cardiopulmonary or Neurology focus

Join The CTI Team•Covington, KY

15h

About The Position

The Clinical Scientist will perform medical monitoring activities under the oversight of a medical director. This includes reviewing protocols and investigator's brochures, medical budgets, preparing the medical monitoring plan, training project teams, supporting site identification and feasibility, assisting sites with clinical questions, participating in medical meetings, reviewing and analyzing medical and safety data, and presenting data to stakeholders. The role also involves providing guidance on medical and scientific aspects of projects, analyzing and synthesizing clinical information, participating in clinical problem-solving and decision-making for clinical trials, leading medical data and safety reviews, identifying safety trends, and ensuring patient safety and clinical trial integrity. Additionally, the Clinical Scientist will lead organizational activities to optimize medical services in Medical Affairs.

Requirements

Ability to make clinical decisions under the oversight of an MD.
Ability to work in collaboration with medical professionals.
Ability to apply clinical/patient care experience to the research setting in the context of clinical trials.
Ability to integrate scientific medical data with superior written and oral communication skills.
Ability to communicate effectively (both verbally and in writing).
Ability to assimilate complex medical and/or research information.
Ability to analyze and interpret scientific data.
Working knowledge of scientific and research principles and techniques of data analysis, interpretation, and clinical relevance.
Working knowledge electronic data capture systems and data visualization tools.
Working knowledge of Code of Federal regulations, ICH Guidelines, Good Clinical Practice, and applicable US regulatory guidance.
Ability to work effectively both independently and in a team setting to develop high quality, scientifically rigorous materials, and presentations.
Working knowledge of Microsoft Office Suite including Word, PowerPoint, Excel, OneNote, as well as Access, Adobe, SharePoint, and others.
Ability to become proficient in new software applications.
Working knowledge of basic business-related financial and business development concepts.
Strong organizational, problem-solving, and time management skills.
Flexible and able to pivot to work toward changing priorities and goals.
Able to multi-task.
Self-driven and able to work in a fast-paced environment with competing priorities.
Able to receive constructive criticism and be open to learning new approaches for continued growth.
Direct experience in clinical research and clinical development, with experience reviewing and interpreting data especially in rare disease, solid organ transplant, hematology/oncology, cell and gene therapy, central nervous system disorders, and other complex indications.

Nice To Haves

Experience in direct patient care, clinical decision making, and working in collaboration with medical professionals.

Responsibilities

Perform medical monitoring activities under the oversight of a medical director.
Review the protocol and investigator’s brochure.
Review medical budgets.
Prepare the medical monitoring plan.
Train project teams on the protocol.
Inform site identification and feasibility activities.
Support sites with clinical questions.
Participate in medical meetings.
Participate in medical and safety data review and analysis.
Prepare and present data to internal and external stakeholders.
Provide guidance to clinical teams on the medical and scientific aspects of assigned projects.
Analyze and synthesize clinical information.
Participate in clinical problem-solving and clinical decision-making in the setting of clinical trials and studies.
Lead and participate in medical data and safety reviews, including identifying critical safety trends and following up with sites/investigators to obtain additional information and to assess clinical events.
Ensure patient safety and clinical trial integrity.
Lead project-specific and department-wide organizational activities to optimize the efficiency and quality of medical services in Medical Affairs.