Responsibilities:
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 obtain 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. Communicate 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 escalate 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 best practices.
Trains new personnel in processes and systems.
Utilizes local knowledge to contribute to the identification and development of new sites.
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