Being an Executive Assistant, I am responsible in all the administrative tasks such as preparing and formatting information for internal and external distribution, writing letters and memos, compiling data for reports, creating computerized presentations, writing reports, transcribing dictation, editing, proofreading and other information preparation duties, email and telephone handling and maintaining company records. I am also the one who oversees the work of clerical and other administrative employees, as well as making sure that everything is in place for the office to function smoothly. Keeping up with office supply inventory to negotiating leases and purchasing agreements to approving vacation requests for clerical employees were some of my tasks also.
For the first 3 years being a Document Analyst, my job is to independently develop, draft and compile research protocol documents and all materials required for regulatory submissions such as Consent Form, Investigator's Brochure, Clinical Research Forms, Diaries, Clinic Logs, Statistical Analysis Plan, and Clinical Study Report in compliance with external policies, manage and oversee new study initiation process, including educating study staff and sponsors, resolving issues and providing regulatory guidance and support, facilitate and participate in committee meetings, ensure procedures are followed, responsible for compiling, organizing, and storing all session documentation and communicating results as appropriate, revise submissions for identified problems and issues and resolve any procedural issues that might arise in order to ensure timely response; advise investigator on remedies and revisions, maintain regulatory documents, monitor and recommend improvements for tracking regulatory documents and collaborate on development of standard operating procedures, training, and documentation.
Then, I am exposed to leading and handling the Regulatory Documentation Team for the next 3 years. I oversee day-to-day tasks of all the tea-----------mbers and submit accomplishment reports to our client daily. Before submitting all the regulatory documents to the Regulatory Board, I was the one who checks all the works of my tea-----------mbers and revise the documents as needed to avoid discrepancies. I also lead the Protocol Review to ensure that every participant in the clinical research study understands all the procedures and to check if all the documents and stuffs needed to run a trial are ready and complete. I took down minutes of the meeting every protocol review to record any changes and improvements there have been and mailed it to all the concerned staffs.
