Senior Clinical Trial Administrator (CTA) performs study-related tasks as required by the Department, including (but not limited to): communicate with Project Team and members of the project team regarding study updates, maintain documentation as required by protocols, SOPs and regulatory standards, to ensure timely production of high quality clinical data, provide system’s support, track information related to the status of study activities and assist with general administrative functions as required.
Essential Job Duties:
1) Documenting and tracking study activities using relevant forms and tools, as well as relevant Project Management System.
2) Preparation of study site specific materials in accordance with relevant SOPs
3) Complete minute taking and documentation for sponsor/external or internal teleconferences as requested
4) Setting up and maintaining tracking systems for e.g. study supplies and investigator payments
5) Create and main contact list of study team members, study sites, and external suppliers/contract organizations
6) Support Investigator Meetings.
7) Train and mentor less experienced Clinical Trial Administrators
8) Set up and maintain clinical investigator files and documentation
9) Assist with coordinating study level vendors as requested
10) Organize/prepare for client meetings/teleconferences
11) Liaise with all other departments to ensure the smooth running of the study as needed
12) Provide clerical support to project team (e.g., proof-reading and editing correspondence, large and small documents, mailings, shipment of study files, fax and photocopy documents, assemble study documents, and arrange meetings, etc.)
13) Maintain paper trial master file documentation and tracking/archiving as applicable
14) Might be requested to work in a client facing environment
15) Perform other administrative duties as assigned by management
Diploma -Secondary Education or equivalent
· Minimum two (2) years administrative experience or equivalent training/experience
· Good oral and written communication skills
· Proven leadership within the CTA group
· Aptitude for handling and proof-reading numerical data, some spreadsheet software competency
· Good organizational and time management skills
· Computer literacy (Microsoft Office and spreadsheet software),
· Good typing skills
· Good spelling and proof-reading skills
· Aptitude for handling and reviewing numerical data
· Ability to operate standard office equipment (e.g., fax, copier)
· Works efficiently and effectively in a matrix environment
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