Responsible for the clinical operations of a project within a defined
regional/global level. Provides oversight of project deliverables, assigned
Clinical Research Associate (CRAs) and Investigator sites in accordance with the
Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and
local regulations. The COL acts as a primary liaison between the CRAs and the
clinical project team. Additional responsibilities include project specific
training of CRAs, conducting assessment visits with CRAs, implementation of
enrollment and recruitment strategies, preparation of the monitoring plan and
other structural documentation and the oversight of monitoring visit scheduling,
site and monitoring performance metrics, issue escalation and corrective
actions. The COL will develop study tools for site and CRA use, review visit
reports, review and track protocol deviations, and support other objectives for
clinical operations and the clinical project team.
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Project Oversight
- Overall oversight of (a group of) regional CRAs to ensure (site) compliance
with study protocol, study plans, ICH-GCP, local regulations and study
timelines.
- Monitoring support visits (Co-monitoring), per project requirements, to aid
the site/CRA in the satisfactory performance and compliance with standards
mentioned above.
- May support clinical project team by providing oversight of study
deliverables related to other departments (e.g. Data Management, TMF
Operations, etc.)
- Oversee regional startup and feasibility activities.
- Assist in vendor management activities as required per project.
- Perform review of visit reports for quality, compliance and appropriate site
management.
- Assure compliance with high quality and timely project deliverables according
to the project requirements and the monitoring plan.
- Proactive management of site and country performance (recruitment, data
collection, document collection, TMF review etc.) and inform clinical project
team on progress.
- Contribute to financial project management processes as applicable. May
include but may not be limited to input on revenue recognition, site
payments, and site pass-through expense review.
- May be required to manage/oversee investigator sites including CRA
responsibilities, on a temporary or permanent basis.
Project Liaison
- Conduct regular global CRA calls with the monitoring and site management
team, as well as individual/country CRA calls
- Attend meetings with Study Sponsor to provide status updates on country and
site progress
- Provide operational support and guidance to the monitoring team throughout
project.
- Provide project training/mentoring to regional CRAs on study procedures,
clinical plans and guidelines, and timelines for the study. Ensures study
specific training requirements are completed and documented.
- First point of contact for regional CRAs for study-specific questions and
issues. Escalates to PM and other functions as appropriate.
- Support line managers by providing status updates on utilization and
performance of CRAs.
- Liaise with line manager for assigning sites to CRAs following line manager
allocation of a CRA resource to the project.
- Conduct CRA Assessment visits per departmental requirements to assess the
performance of the CRA against their monitoring responsibilities.
Study Documents and Plans
- Develop training materials and study tools for sites and CRAs, including
monitoring plans.
- Develop and implement enrolment and recruitment strategies together with
clinical project team.
- Develop presentation materials for and presents at Sponsor Kickoff meetings,
Investigator meetings and Sponsor Calls (as needed), and prepares
presentations for Site Qualification Visits and Site Initiation Visits.
Qualifications
- College diploma/degree AND 7-9 years related experience +continuous training
and knowledge/skills upgrading
OR
- Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6
years' experience + substantial on-going job-related training
Other
- Health Sciences, Life Sciences or Nursing specialty preferred, or SoCRA
and/or ACRP Certification/Designation.
- Should have a minimum of 3 years CRA experience, have strong experience with
EDC systems, be proficient with MS Office, have strong written and verbal
communication skills and highly effective interpersonal and organizational
skills.
- Demonstrate the following attributes: proactive, detail oriented, task-driven
and highly organized.
- Demonstrate the critical elements of GCPs and local regulations as they
relate to clinical monitoring, IRB/EC and Investigator responsibilities.
- Demonstrated ability in report writing and strong ability to critically
understand clinical research documents.
- Ability to handle multiple tasks to meet deadlines in a dynamic environment.
Working Conditions
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$78,000 - $130,000 a year
Accommodations for persons with disabilities are available on request in respect
of all aspects of the recruitment and selection lifecycle. Requests can be
directed to recruitment@alimentiv.com
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