Description
Duties- Plans, implements and executes FDA registration trials to support clinical claims.
- Supports the preparation of reports and summary documents (for internal and external customers) for product registration.
- Assists team in budget and contract negotiations with study sites, central laboratories and CROs.
- Study start-up, monitoring and study close-out activities being performed within the team. Ensures adherence to regulations, guidelines and departmental standard operating procedures on the part of direct reports and monitors the trial budgets and timelines.
- Plans and prepares execution of studies through all phases of the study process
- Provides technical input to study designs and clinical development plans
- Reviews study protocols, reports and manuscripts
- Works with Data Management and Biometrics staff on the design of documents and processes for the collection of study data from participating sites
- Ensures compliance with Good Clinical Practices, regulations, SOPs and protocols
- Collects and maintains legal and regulatory documentation, as applicable
- Ensures accurate and complete study management/data collection and transfer into the data management system
- Ensures site compliance with regulations and study protocol
- Acquires and maintains technical knowledge of product line
Requirements:
- 3-5 years of CRA experience
- IVD experience preferred
- Experience bringing a trial from site selection to close out
- Vendor management
- Oncology clinical trial experience
- Bachelors or Masters in Biology, Chemistry, Molecular Biology or related discipline.
- Global study experience
- Budget and contract development
- MSWord, Excel and PowerPoint skills are required.
- Excellent written and verbal communication skills
To find out more about Real please visit www.realstaffing.com