We're looking for a Trial Master File Specialist, working in the Pharmaceuticals & Medical Products industry in San Rafael, California, United States.
Job description:
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).
Prepares inventory, shipment and retrievals of records to/from offsite storage.
Details
The pay range we are offering is 30 to 38 per hour. This position may present an opportunity to go permanent.
Our Client
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Education:
AA preferred (Combination of education and work experience providing competencies to perform the required responsibilities specific to position)
Skills:
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
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
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.