Site Management and Monitoring Specialist
hace 1 mes
Job Overview
We are seeking a highly skilled Site Management and Monitoring Specialist to join our team at Novasyte. This individual will be responsible for ensuring the quality and integrity of study site practices, adhering to applicable regulations and guidelines.
Key Responsibilities:
- Perform site monitoring visits, including selection, initiation, monitoring, and close-out visits, in accordance with contracted scope of work and regulatory requirements.
- Administer protocol and related study training to assigned sites and establish regular lines of communication to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices and escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form completion and submission, and data query generation and resolution.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings, and action plans by submitting regular visit reports, generating follow-up letters, and other required study documentation.
Qualifications:
- High School Diploma or equivalent degree in a scientific discipline or healthcare preferred.
- At least 1 year of on-site monitoring experience.
- Good knowledge of and skill in applying applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills, including proficiency in Microsoft Word, Excel, and PowerPoint, and use of a laptop computer and iPhone and iPad (where applicable).
- Written and verbal communication skills, including a good command of the English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Salary Range: $65,000 - $85,000 per annum, depending on experience.
About Us: Novasyte is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make a significant impact – to help our customers create a healthier world.
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