Description
Role Objectives:- To coordinate and execute clinical research activities for multisite clinical studies
- To ensure investigator and site compliance with the study protocol, FDA regulations, ICH Guidelines and Good Clinical Practice (GCP)
- To ensure timely implementation of clinical research plans for assigned products
Responsibilities:
- Works under general supervision, and participates in the design, planning, implementation and overall direction of clinical research projects; May co-ordinate the activities of relevant colleagues within the Company and investigators to ensure compliance with the overall scientific study objectives. May work with international investigators and key customers as well.
- Travels to field sites to monitor studies.
- Works with Data Management and Biostatistical staff on the design of documents and processes for the collection of study data from participating sites.
- Assists with the coordination of training and certification of study site personnel.
- Manages material logistics for the studies.
- Conducts reference material testing in-house.
- Keeps informed of trends and developments in clinical research.
Requirements:
- B.S. or M.S. in Biology, Chemistry, Molecular Biology or related discipline.
- 3-5 years relevant clinical research experience
- Strong lab skills
- Strong written and verbal communication
- 2+ years of clinical monitoring experience
To find out more about Real please visit www.realstaffing.com