Clinical Research Scientist - Santa Monica, United States - Unicon Pharma Inc

Description

Job Description

Description:

• Acquires and utilizes knowledge of clinical trial design to develop specific study concept sheets and protocols.
• Participates in protocol review discussions concerning scientific and procedural aspects of study design.
• 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.
• Supports priorities within functional area.
• Anticipates moderately complex obstacles within a clinical study and with guidance implements solutions.
• May be asked to coordinate teams and provide direction.
• May lead two or more specific components of departmental strategic initiatives.
• Must be able to enter a new therapeutic area and summarize scientific information that is available in published literature to integrate into new study development.
• 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.
• May be sought out for advice by others within the company to help make better decisions and resolve moderately complex problems.