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