I perform assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials. Responsible for providing delivery and expertise in one or more of the following functional areas:investigator site contracts, ethics and regulatory submissions, and review and finalization of essential documents required for site initiation. Ensures local activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards. Ensures an efficient start-up process on assigned studies. May act as main contact with Regulatory Authorities (RA) and Central/Regional Ethics Committees (ECs).

Manages study trial documentation from the completion of the regulatory start-up packet to study closure. Provides detailed reports of QC checks with a plan for resolution of problem trends and/or areas where improvement is needed. Assists the department manager with monthly budget reviews. Represents Document Maintenance at study team meetings, teleconferences, and audits. Collects information concerning study conduct from these meetings to disseminate to other appropriate Document Maintenance associates. Provides training to the project team regarding TMF management. Receives and processes trial regulatory documentation from the point of site activation through study closure. Tracks essential documents in tracking database using standardized naming conventions. Properly files hard-copy study documentation appropriately in the TMF. Properly indexes electronic documents based on sponsor electronic filing requirements and sponsor index hierarchy. Pre-populates expected regulatory documents in tracking tool. Identifies documents with expiration dates per ICH/GCP, sponsor and Kendle requirements and include these documents with expiration intervals in the tracking tool. Collaborates with study team and CRAs to ensure all trial regulatory documents are collected and maintained in the TMF. And, other duties as assigned.

Composes and types complex or confidential correspondence, Assists clients, customers, or others with general information, Acts as an information source on organizational policies and procedures. Gathers, compiles, and reports information relevant to departmental needs and projects. Participates in planning functions. Maintains study team lists, Initiates required administrative reports. Sets up and administers filing systems. Arranges meeting and appointment schedules. Attends project team meetings. Takes / distributes meeting minutes May assist in developing, implementing, and monitoring internal operating systems and procedures. Operate word processors or personal computer (PC) equipment to type tables, charts, memorandums, reports, and other material requiring speed and accuracy. Sets up and maintains alphabetical, numerical, and subject filing systems. Tracks correspondence to/from site, providing feedback to LCRA and project team. Gathers information, searches files and records, and makes personal contacts to obtain specific information in order to prepare detailed reports and compose routine correspondence. Other duties and assignments as requested for the overall performance of the Business Unit and Company.

Composes and types complex or confidential correspondence, Assists clients, customers, or others with general information, Acts as an information source on organizational policies and procedures. Gathers, compiles, and reports information relevant to departmental needs and projects. Participates in planning functions. Maintains study team lists, Initiates required administrative reports. Sets up and administers filing systems. Operate word processors or personal computer (PC) equipment to type tables, charts, memorandums, reports, and other material requiring speed and accuracy. Sets up and maintains alphabetical, numerical, and subject filing systems. Tracks correspondence to/from site, providing feedback to LCRA and project team. Gathers information, searches files and records, and makes personal contacts to obtain specific information in order to prepare detailed reports and compose routine correspondence. Other duties and assignments as requested for the overall performance of the Business Unit and Company.

Manage the eKendle College support line and emails. Assist with the Learning Management System (attach all WBTs, Courses & Classes and the documents for each) Enter all course/WBT completions. And, various other duties as assigned.

Scheduling phone and in-house interviews, travel arrangements for interview candidates, working directly with outside recruiters, performing phone interviews, processing check requests, handling multiple reports, processing offer letters to candidates and various other administrative tasks.