Work Schedule

Environmental Conditions

Job 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 and Other Job Information: 
Crucial 
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. 
 May review and track of local regulatory documents.
 May provide system support (i.e., Activate & eTMF). May support RBM activities. 
 May support the maintenance of study specific documentation and systems, 
including, but not limited to, study team lists, tracking of project specific training 
requirements, system access management and tracking of project level activity 
plans in appropriate system(s). 
 Transmits documents to client and centralized IRB/IEC. 
 Maintains vendor trackers. 
 Supports start-up team in Regulatory submissions. 
 Works directly with sites to acquire documents related to site selection.

Education and Experience: 
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification. 
Bachelor's degree preferred. 
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 
to 1 year). 
In some cases an equivalency, consisting of a combination of appropriate education, training 
and/or directly related experience, will be considered sufficient for an individual to meet the 
requirements of the role.