Description
Syneos Health is seeking an On-site Monitor to join their Clinical Solutions team. The successful candidate will perform site management activities in compliance with Company and Sponsor Standard Operating Procedures (SOPs) and Work Instructions (WIs).
Job Responsibilities
- Perform site management activities in compliance with SOPs and WIs
- Assure compliance with local regulations and guidance
- Conduct site management activities as per agreed Scope of Work (SoW), Site Management Plan (SMP) and relevant guidelines
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness
- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents
- Demonstrates diligence in protecting the confidentiality of each subject/patient
- Assigned sites data review, assisting with data query resolution and missing data follow-up
- Maintain effective, accurate and timely communication with site staff and project team
- Ensure all assigned sites are trained and compliant with requirements of the study protocol, informed consent process, data collection requirements/data collection tools and safety reporting
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions
Qualifications
- Minimum 1 year relevant onsite monitoring experience required
- BA/BS degree in science/health care field or nursing degree or equivalent combined education and experience
- Must be proficient in Microsoft Office Suite (Word, Excel, and PowerPoint), email/voicemail, and Clinical Trial Management and EDC systems
- Previous site management (in-house, on-site, Study Coordinator) or equivalent experience
- Excellent communication, time management, organizational, documentation and customer service skills
- Knowledge of local requirements for Real World Late Phase study designs as well as Real World Research and relevant regulations including GPP
- Excellent customer focus (internal and external) and able to interact professionally with a client organization and study site
- Willingness to work within a team-oriented environment
- Ability to handle multiple tasks (across multiple studies as necessary) and prioritize accordingly to achieve study timelines
- Excellent command of written and spoken local language, if not English, as well as English required
- Ability to develop good working relationships via oral communication and good phone etiquette
- Ability to travel up to 60% on a regular basis depending on assignments and study phase
Additional Information
Syneos Health is committed to building an inclusive culture – where you can authentically be yourself.