Description
Responsibilities:Responsible for implementing set-up, execution, oversight and reporting of clinical studies while ensuring that the conduct of the trial is in compliance with the protocol, ICH/GCP, and applicable regulatory requirements.
- Lead multifunctional team through clinical studies activities that meet ICH/GCP and SOP requirements
- Develop clinical trial protocol synopsis, protocols, amendments and informed consent documents
- Develop study budget and timelines
- Procure and manage contracts with CROs, study vendors and investigative sites
- Co-monitor at investigative sites to evaluate study site and field monitor performance
- Collaborate with medical experts, clinical study sites, and clinical study vendors
- Performs in-house review of clinical database listings for completeness and accuracy
Requirements:
- BS/BA degree in a life science, RN, or related field
- 6+ years of relevant clinical experience in a CRO, pharmaceutical, or biotechnology company (including on-site monitoring experience)
- Able to collaborate effectively with the study team, cross-functional team members, and external partners
- Knowledge of ICH/GCP and FDA regulations
Preferred:
- Experience in oncology
- Experience in global trials
- Experience with Electronic Data Capture systems
To find out more about Real please visit www.realstaffing.com