Job Description - Sr Clin Ops Specialist (20007610)
Sr Clin Ops Specialist-(20007610)
The position is responsible for providing clerical,
technical and administrative support to one or more business units or clients
within Clinical Operations. Provides overall study support to functional leads
to ensure the successful completion of project deliverables. Mentors and/or
trains less experienced staff.
·Responsible for performing activities in compliance
with applicable Corporate and Clinical Operations Policies, Standard Operating
Procedures and Work Instructions
·Assists Clinical Monitoring staff with site
management activities, including serving as a Sponsor representative for sites
on assigned studies, and communicating with sites to ensure compliance with
protocol requirements, study procedures and relevant guidelines
·Creates and assists with maintenance of project
files, handles project correspondence
·Participates in file audits
·Prepares and maintains site manuals, reference
tools and other documents
·Maintains, updates, and inputs clinical tracking
information into databases
·Tracks incoming and outgoing clinical and
regulatory documents and updates for investigator sites, studies, project team,
·Manages shared mailbox, processes site requests and
routes correspondence appropriately
·Coordinates the ordering, packaging, shipping and
tracking of site supplies and materials
·Assists with coordination of team meetings, attends
meetings and prepares accurate meeting minutes and action items
·Routinely anticipates, identifies and resolves
potential issues and implements corrective actions, seeking guidance as needed
to resolve more complex issues
·Maintains overall awareness in the field of
clinical research, as well as assigned areas, by completing all necessary and
·May provide training or mentorship to more junior
level Clinical Operations Specialists (COS).
QUALIFICATION REQUIREMENTS (please
indicate if ‘preferred’)
Associates degree preferred or
Experience in clinical
research/pharma/biotech or related field considered in lieu of degree
Good knowledge of medical terminology,
clinical data, and ICH/GCP preferred
Ability to successfully prioritize and
work on multiple tasks
Strong attention to detail, accuracy
and organizational skills
Excellent communication, presentation,
and interpersonal skills
Ability to embrace new technologies
Minimal travel up to 10% may be required
Tasks, duties, and responsibilities as listed in this job
description are not exhaustive. The Company, at its sole discretion and with no
prior notice, may assign other tasks, duties, and job responsibilities.
Equivalent experience, skills, and/or education will also be considered so
qualifications of incumbents may differ from those listed in the Job
Description. The Company, at its sole discretion, will determine what
constitutes as equivalent to the qualifications described above. Further,
nothing contained herein should be construed to create an employment contract.
Occasionally, required skills/experiences for jobs are expressed in brief
terms. Any language contained herein is intended to fully comply with all
obligations imposed by the legislation of each country in which it operates,
including the implementation of the EU Equality Directive, in relation to the
recruitment and employment of its employees.
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