Clinical Research Scientist

Yoh covers the diverse talent and workforce management needs in the Aviation, Engineering, Health Care, IT, Life Sciences, Media & Entertainment and Telecom industries. You can be confident that we have the right talent and managed solution for you. You need it. Yoh has it!

• Assist the Clinical Research Physician to interface with project team members including: Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management
• Prepare or assist with preparation of key documents e.g. Investigator Brochures, regulatory submission documents, internal or external presentations, etc.
• Protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate)
• Clinical study report preparation
• Review literature and prepare summary documents for inclusion in IB, protocols regulatory submission documents, etc.
• Oversee and challenges the adequacy of planning for study implementation
• In collaboration with the project physician, directs the planning and implementation of clinical programs to meet corporate and clinical research goals
• Assist Clinical Research Physician to make recommendations, take action and provide clinical research expertise related to projects
• Work with department managers to prioritize project/study timelines to ensure adequate staffing (e.g. data management, drug supply, clinical operations, drug safety)
• Participate and present at investigator meetings

What You Need to Bring to the Table:

• Degree in Life Sciences (e.g., BS in nursing, pharmacy or related medical field)
• Minimum 2 yrs. experience in medical or technical writing
• Must be able to relate effectively to people at all levels of the organization
• Extensive medical/scientific and clinical research knowledge
• Knowledge of clinical trial design, basic statistics, pharmacodynamics and pharmacokinetics
• Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions
• Experience in all aspects of the drug development process
• Knowledge of GCP and ICH Guidelines
• Experience in presenting at Investigator Meetings
• Clinical monitoring experience

The Big Picture - Top Skills You Should Possess:

• Clinical research
• Clinical monitoring
• Data management
• Clinical study