Job Details
- Title: Clinical Project Associate
- Code: RCI-08090
- Location: Foster City California (CA) 94404
- Posted Date: 03/27/2020
- Duration: 18 Months
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- Name:Mangesh Kanade
- Email: mangesh.kanade@rangam.com
- Phone: 908-704-8843 ✖ 260
- 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
- Contributes to the design and development of CRFs, Data Management Manuals and Data Analysis Plans
- Addresses questions regarding scientific and related procedural issues from Investigators
- 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