Description
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Responsibilities:
- Conduct site monitoring visits in accordance with contracted scope of work and Good Clinical Practice
- Collaborate with sites to adapt, drive, and track subject recruitment plans
- Provide protocol and related study training to assigned sites and establish regular lines of communication
- Evaluate the quality and integrity of study site practices and escalate quality issues as needed
- Manage study progress by tracking regulatory submissions, recruitment, CRF completion, and data query resolution
- Ensure site documents are available for filing in the Trial Master File (TMF) and verify Investigator's Site File (ISF) maintenance
- Create and maintain documentation regarding site management, monitoring visit findings, and action plans
- Collaborate with study team members for project execution support
Qualifications:
- High School Diploma or equivalent Degree in scientific discipline or health care preferred
- At least 2 years of on-site monitoring experience
- Good knowledge of applicable clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Proficiency in Microsoft Word, Excel, and PowerPoint, and use of a laptop computer and iPhone and iPad (where applicable)
- Strong written and verbal communication skills, including good command of English language
- Organizational and problem-solving skills, and effective time and financial management skills