Nos aseguraremos de que las personas con discapacidades reciban adaptaciones razonables para participar en el proceso de solicitud de empleo o entrevista de trabajo, para que puedan ejercer las funciones de trabajo esenciales y recibir otros beneficios y privilegios del empleo. Comuníquese con nosotros para solicitar una adaptación.
Clinical Trial Coordinator
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Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Summarized Purpose:
Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring
files are reviewed according to the schedule detailed in the organization's SOP and department mentorship
document. Provides administrative support for site activation activities. Aids the development of the
critical path for site activation within assigned projects in support of rapid site activations. Represents
CRG personnel. May apply local knowledge, organization systems, external site lists and sponsor
directives to develop and review site lists that are suitable for the strategic needs of feasibility activities
and to provide local input into the site tiering process. May act as a buddy during onboarding phase and
provide training to new staff as needed.
Essential Functions:
According to the specific role (Central or Local), coordinates, oversees and
completes functions on assigned trial(s) activities as detailed on the task matrix.
Performs department, Internal, Country and Investigator file reviews as
assigned, and documents findings in appropriate system(s).
Ensures allocated tasks are performed on time, within budget and to a highquality standard. Proactively communicates any risks to project leads.
Provides system support (i.e., Activate & eTMF) and ensures system databases
are always current.
Performs administrative tasks on assigned trials, including, but not limited to,
timely processing of documents sent to Client (e)TMF as assigned, performing
(e)TMF reviews, distributing mass mailings and communications as needed,
providing documents and reports to internal team members.
Analyzes and reconciles study metrics and findings reports. Assists with
clarification and resolution of findings related to site documentation.
Assists with coordination, compilation and distribution of Investigator Site File
(ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
Assists with study-specific translation materials and translation QC upon request.
Maintains knowledge of and understands SOPs, client SOPs/directives, and
current regulatory guidelines as applicable to services provided.
Where applicable, conducts on-site feasibility visits (Asia Pac only).
May support scheduling of client and/or internal meetings.
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Nos aseguraremos de que las personas con discapacidades reciban adaptaciones razonables para participar en el proceso de solicitud de empleo o entrevista de trabajo, para que puedan ejercer las funciones de trabajo esenciales y recibir otros beneficios y privilegios del empleo. Comuníquese con nosotros para solicitar una adaptación.