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.
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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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$61,000 - $102,000 a year
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