Job Posting for Clinical Operations Assistant at Worldwide Clinical Trials
SUMMARY: The Clinical Operations Assistant is a full-time position responsible for completing all assigned projects for Clinical Operations in a timely and accurate manner while interfacing directly with in-house personnel and field employees. Key functions include management of essential document submission to Trial Master Files, supporting field personnel with Microsoft Office, and providing additional administrative support when time permits.
Manage and track document flow of essential documents from investigator sites to the Trial Master Files
Collect, review, organize and perform quality review of information for database entry ensuring the suitability of submissions
Function as TMF Submitter for assigned trials and manage TMF submission process for site-level documents.
Manage, track and ensure proper re-submission of rejected TMF documents for site level
Track, identify and escalate trends in omissions of submitted documents from sites and/or Clinical Research Associates
Develop and maintain documents, tools, forms and related items in MS Word, Excel, Access, PowerPoint and Publisher, including reformatting and troubleshooting issues with existing documents
Assist Clinical Operations personnel with completion of study-specific tasks (e.g. study initiation, and preparation of study file notebooks)
Maintain interdepartmental communication to ensure consistency and availability of new forms and revisions
Audit and resolve issues of redundancy and consistency of Clinical Operations documents on the shared drive, SharePoint and portals
Provide administrative support to the Clinical Operations department
Develop and distribute periodic communication materials
OTHER SKILLS AND ABILITIES:
Excellent organizational skills, time management, written and oral communications
Strong interpersonal skills in a fast-paced and rapidly changing environment
A broad range of knowledge and advanced skills in the use of computer software including, but not limited to, word-processing, spreadsheets, electronic communications, and graphics
Ability to prepare presentations in a clear, focused, and concise manner
Ability to exercise independent judgment with sensitivity to decisions requiring supervisory approval
General knowledge of clinical research principles
Knowledge of standard operating procedures
Science-related Bachelor’s Degree and 1 or more years’ experience in clinical research required.