The partner company of Jobgether is looking to solve the problem of ensuring global clinical studies are conducted in compliance with regulatory standards while advancing innovative therapies that can transform patient care in the United States.
Requirements
- 5+ years of clinical research monitoring experience, preferably in medical devices.
- Knowledge of federal and local regulations, ICH, GCP, and the Declaration of Helsinki.
- Strong verbal and written communication, organizational, and interpersonal skills.
- Ability to work independently with minimal oversight while managing multiple projects in a fast-paced environment.
- Knowledge of clinical documents including protocols, informed consent forms, case report forms, and study plans.
- Understanding of GCP, SOPs, and regulatory requirements.
- Experience with investigational product requirements and device accountability at study sites.
Responsibilities
- Conduct site qualification, initiation, monitoring, and close-out visits in alignment with GCP, SOPs, and regulatory requirements.
- Serve as the primary contact for site questions, supporting enrollment, study conduct, and protocol compliance.
- Collaborate with study teams to develop and execute clinical documents including protocols, informed consent forms, case report forms, and study plans.
- Communicate site performance, trends, deficiencies, and concerns to project teams and investigators.
- Ensure quality and completeness of central and site master files.
- Oversee investigational product requirements and device accountability at study sites.
- Support site audits, investigator meetings, and other study-related activities as assigned.
Other
- Bachelor’s degree in a relevant field of study.
- Willingness and ability to travel up to 30% by automobile or air for site visits, day trips, and overnight stays.
- Self-starter with strong problem-solving and prioritization skills.
- Ability to work independently with minimal oversight while managing multiple projects in a fast-paced environment.
- Strong interpersonal skills.
