Clinical Research Scientist

. Responsibilities: -Participates in protocol review discussions concerning scientific and procedural aspects of study design.
-Oversees the scientific aspects of clinical studies throughout duration of study.
-Adheres to strict regulatory requirements of study conduct and industry standards of Good Clinical Practice.
-Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed with appropriate guidance and supervision.
-With supervision, contributes to the design and development of CRFs, Data Management Manuals and Data Analysis Plans.
-With supervision, addresses questions regarding scientific and related procedural issues from Investigators.
-With supervision, contributes to the preparation and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations.
-Assists in the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and NDAs.

Requirements:

-Typically a higher degree such Pharm.D or PhD in clinical research or clinical pharmacology in a pharmaceutical company or contract research organization along with good working knowledge of clinical trial design and protocol report writing is desirable.
-Experience in antivirals / anti-infectives desirable.
-Excellent verbal and written communication skills and interpersonal skills are required to maintain working relationship with team members to ensure scientific integrity of clinical studies.
-Good working knowledge of infectious diseases and other related specialties.
-Must be able to lead two or more specific components of departmental strategic initiatives.

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