Description
Position and Primary Responsibilities:- Partner with clinical staff and CROs for planning/coordination of Investigator Meetings, CRF development, generation of study tools, regulatory document collection, patient recruitment programs, review of monitoring and data management plans
- Partner with members of Clinical, Regulatory and Manufacturing Departments to meet clinical milestones/timelines
- Revise/amend study protocols and consent forms
- Day-to-day management of vendors
- Conduct site qualification, initiation, monitoring and close out visits as well as co-monitoring visits with regional CRAs as needed
- Conduct initiation, routine monitoring and closeout visits for PTI studies managed internally
- Communicate with sites and regional CRAs to ensure proper study conduct
- Review regional CRA monitoring reports
- Proactively identify issues and propose appropriate solutions
- Communicate status of clinical studies to Clinical Operations Senior Mgmt
- Track costs for individual studies and review monthly invoices
- Manage drug supply activities
- Oversee safety reporting with medical monitor
- Assist in the development/implementation of departmental procedures and SOPs
Background, Education and Experience Required:
- 5+ years of clinical research experience
- 1+ years of clinical project management experience
- Bachelor's degree in health sciences
- In depth knowledge of ICH/GCP and drug development process
Personal Characteristics:
- Excellent communication skills (oral, written, listening)
- Honesty, integrity, hard-working and committed to achieving difficult goals
- Effective interactions with management
- Proactive and independent
- Capable of working with multiple contractors, academic and investigative sites to manage and focus priorities
- Positive, outgoing and enthusiastic personality
To find out more about Real please visit www.realstaffing.com