Description
Responsibilities:- Work closely with the Clinical Trial Managers, Medical Monitor, Drug Safety, Clinical Data Management, Regulatory/QA
- Contribute to preparation, review, and management of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
- Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures
- Responsible for review and IP release packages
- Participate in study close-down activities, e.g., reconciliation of un-used study supplies and clinical study report development
Desired Qualities:
- Cardiovascular, hematology and/or oncology (Phase I - 3) study experience
- Previous experience working with an electronic data capture system required
- Availability for potential travel domestically and internationally
Requirements:
- Minimum of 3-4 years relevant work experience of which ~ 1.5 years of site monitoring experience
- Experience in the pharmaceutical industry and working knowledge of GCP/ICH guidelines and the clinical development process
- BS/RN degree or equivalent
To find out more about Real please visit www.realstaffing.com