Description
Job Responsibilities:- Develop study timelines, milestones and budgets in collaboration with trial members
- Develop study protocols with guidance from Medical Monitor
- Develop case report forms, informed consent forms and other study-related documents
- Review and qualification of investigational sites
- Participate in selection of, management and oversight of CROs and other vendors to ensure that clinical studies are executed properly, on time and in compliance with GCPs
- Review and approve vendor and site invoices
- Manage external resources, as required
- Conducts site evaluations/initiation/monitoring and closeout visits, as required
- Contributes to Clinical Study Reports, NDAs, and other clinical/regulatory/safety documents.- ensuring reports are controlled for quality, signed off and published with copies going to Regulatory Authorities and Ethics Committees, as required
- Collect and archive documents for inclusion in the Trial Master File
- Ensure study compliance by understanding and applying all relevant SOPs
Skills / Qualifications:
- Bachelor of Science degree in a relevant scientific discipline (Advanced degree preferred)
- 5+ years' CRO or pharmaceutical company experience, as a Clinical Research Associate with thorough knowledge of planning, implementing, and managing single and multi-center clinical trials, CNS experience preferred. International study experience is a plus
- Strong written and verbal communication, interpersonal, problem solving and negotiation skills
- Good presentation skills: ability to present to diverse groups of clinical staff (at project or investigator meetings)
- Proven organizational skills; ability to manage multiple priorities and work under pressure
- Computer software: Microsoft Word, Excel, PowerPoint, Project, Visio
- Ability to travel
To find out more about Real please visit www.realstaffing.com