Work Schedule

Environmental Conditions

Job Description

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 assined  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 and line  manager as appropriate. 

- 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. 

- Reviews and supervises local regulatory documents. 
- Analyzes and reconciles study metrics and findings reports. Assists with  clarification and resolution of findings related to site documentation. 

Maintains vendor trackers. 

- 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. 
- Assists with technical and administrative support for projects in teamwork 
with internal departments and team members. 

- Maintains knowledge of and understands SOPs, client SOPs/directives, and 
current regulatory guidelines as applicable to services provided. 

- Ensures that trial status information relating to activities is accurately maintained  in the database and current at all times. 

- Where applicable, develops and manages relationship with client local affiliates. 
- Champions the inclusion of Strategic Teamwork sites into the process. 

-Where applicable, conducts on-site feasibility visits (Asia Pac only). 

-Trains new personnel in processes and systems. 
- May support the maintenance of study specific documentation and global 
support with specific systems, tools and trackers, including, but not limited to, 
study team lists, tracking of project specific training requirements, system acess  management for organization/vendor/clients and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and detailing findings in appropriate system(s). 
-May provide system support (i.e., Activate & eTMF). 
-May support RBM activities. 
-May transmit documents to client and centralized IRB/IEC. 
- May attend Kick off Meeting and take notes when required. 
- May support scheduling of client and/or internal meetings 
- May support scheduling and organization of client and/or internal meetings with 
completion of related meeting minutes. 
- Provides support as needed to coordinate with internal departments and ensure 
site start-up activities within the site activation critical path are aligned. 
- Assists the project team with the preparation of regulatory compliance review 
packages. 
- May support start-up team in Regulatory submissions. 
- Occasionally works directly with site(s) to acquire documents related to site 
selection. 
- May develop site list, including research from internal and external sources to 
ensure the site list is reflective of the defined site profile. Ensure current 
investigator and site staff contact details are appropriately maintained in 
company systems. 
- May complete the ‘Site Interest Plan’ in CTMS and collection and delivery of 
associated documents from investigators and site personnel. Document in real 
time all communication, attempts and 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 advances concerns/non-compliance to 
management. 
- May act as the local authority regarding site capacity and experience. Work with 
key local personnel to capture knowledge base and recommend additional sites. 
Harnesses this knowledge base when performing local tiering of sites. 
- May conduct phone interviews, scripted or non-scripted, with physicians and 
other site personnel to discuss standard of care and acquire protocol-level input 
to support trial optimization projects. 
- Liaises with Global Investigator Services to resolve investigator queries in real 
time and maintain ‘accounts and contact’ information. 
- Gives to the development and roll-out of global strategic feasibility 
processes and guidelines.