Performs and coordinates all aspects of the clinical site monitoring services, assessing for protocol and regulatory compliance. Responsibilities include driving investigative site and patient recruitment, conducting source data verification, assessing drug accountability, data collection, (regulatory) document collection, performing qualification, initiation, monitoring and close out visits at investigational sites in accordance with corporate, sponsor and regulatory (ICH GCP and other) standards and guidelines. Represents the corporation by maintaining collaborative relationships with stakeholders.
Investigational Site Monitoring (55-60%)
- Conducts and documents site initiation, routine monitoring and close out visits, reviewing files, forms, and filings to ensure alignment with SOPs, study guidelines and GCP best practices.
- Work with site staff to verify CRF data are consistent with patient clinical source documents.
- Monitor, resolve and/or facilitate resolution of queries arising out of regular and/or safety reviews, adverse events, and other data management activities throughout the trial.
- Conduct remote visits\contacts as requested or as needed.
- Assess and manage Investigational Product supply including supply, accountability, and destruction\return status.
- Ensures site staff is trained on all aspects of the study including but not limited to the protocol, study plans and systems.
Site Recruitment and Setup (15-20%)
- Identify and recruit site investigators, coordinate the movement and delivery of trial materials, samples, tests, and forms, including investigational medicinal product, protocols, SOPs, CRFs, project documents, forms, and support tools.
- Ensure SOPs in place to optimize patient recruitment providing guidance to site teams of inclusion/exclusion criteria.
Investigational Site Management (10-15%)
- Primary clinical site contact for any questions or issues that arise from investigational sites.
- Oversee overall integrity of the study to promote positive working relationships with the site and staff.
- Facilitate and support site staff with access to study systems and ensure sites are compliant with project specific training requirements.
Project Monitoring Lead (5-10%)
- May be required to act as lead CRA on small, local, or single modality projects, providing peer training, contributing to the design of monitoring plans, tools, documents, CRFs and protocols as requested.
- Participate and/or present at study team, kickoff, and investigator meetings, monitor site budget adherence and act as primary contact to sponsors for all monitoring related issues.
Qualifications
- Undergraduate university degree (Bachelor or Honors Bachelor), & 1-3 years' related experience with initial and On-going training.
OR
- College Diploma/Degree, & 4-6 years related experience +substantial on-going job-related training.
Other:
- Health Sciences, Life Sciences, or Clinical Research Specialty preferred, or RPN Certification/Designation.
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