Clinical Research Scientist – III
Job Description
Duties and Responsibilities:
- 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.
Requirements:
- PharmD with 2+ years relevant scientific and/or drug development experience.
- MS with 6+ years’ relevant scientific and/or drug development experience.
- BS or RN with 8+ years’ relevant scientific and/or drug development experience.