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 guidance 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.

• 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 high quality

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 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.

Assists the project team with the preparation of regulatory compliance review

packages.

• Provides support as needed to coordinate with internal departments, ensuring

site start-tup activities within the site activation critical path are aligned.

• May complete the 'Site Interest Plan' in CTMS and collection and delivery of

associated documents from investigators and site personnel.

• Documents in real time all communication, attempts an follow up associated

with site contact and survey responses.

• Supports the review of survey data to ensure responses are logical, complete

and reflective of the question asked.

• Works in collaboration with teammates to achieve targeted deadlines for

assigned projects. Connect with the team and appropriate clinical personnel

regarding site issues and risks.

• Ensures an efficient, effective plan is in place for site contact and follow up.

Ensure compliance with the plan and advance concerns/non-compliance to

management.

• May act as the local expert regarding site capacity and experience. Work with

key local personnel to gather knowledge base and recommend additional sites.

Harness this knowledge base when performing local tiering of sites.

• Liaises with Global Investigator Services to resolve investigator queries in real

time and maintain 'accounts and contact' information.

• Contributes to the development and roll-out of global strategic feasibility

processes and standard methodologies.

• Uses local knowledge to contribute to the identification and development of

new sites.