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San Rafael, CA
Administrative / Clerical
Under limited supervision, assists with the maintenance and filing of records (documents, binders, electronic media, etc.) from Development Sciences
Verifies document receipt
Reviews files at a high level for identification and consistency, (i.e.; number of pages and transmittal form accuracy)
Files, sorts, separates, photocopies, prints, scans, indexes, distributes labels and files a variety of clinical study records and documents.
May enter new and updated records information accurately in a variety of records management databases, such as the Vault eTMF, Clinical Document Management Database, Access and LiveLink (via scan / index software).
Performs searches and produces routine reports (e.g. Study Site Listing from database, BI reports from Livelink, etc.).
Prepares inventory, shipment and retrievals of records to/from offsite storage.
Works with third party offsite storage facilities, in accordance with the DevSci Records Management (DSRM) SOP.
Acquires a basic understanding of Records Management database programs (i.e.; Access databases or other) and assists in the support of these database programs.
Fulfills requests for retrieval, reproduction, and re-filing of records or their electronic images (e.g. pdf) and other related records management requests.
Communicates resource needs to manager to ensure DevSci Records Management is appropriately staffed and equipped for customer support as filing needs fluctuate.
Works according to and assists others in following DSRM department priorities.
1-2 years applicable experience, including a minimum of 1-year relevant Records Management experience, with some knowledge of ICH/GCP, preferred.
Competent in the skills for the Records Management Assistant and the following:
Experience working with regulated files or in a records management environment is preferred
Strong organizational skills
Ability to identify and respond to problems
Strong time management skills
Able to identify Records Management related issues and take appropriate action
Basic understanding of records management requirements in Drug Development
Strong communication skills
Ability to work well with others (strong interpersonal skills)
Has an understanding of the clinical study phases involved in Drug Development and the corresponding records requirements.
Combination of education and work experience providing competencies to perform the required responsibilities specific to position.