Clinical Documentation Specialist II

San Francisco, CA, United States
Jun 28, 2018
Biotech Bay
Required Education
High School or equivalent
Position Type
Full time
Position Summary:

Assists in the coordination of documentation associated with conducting clinical studies. Assists CRAs and other clinical staff with management of trial master file documents, SOPs and record archiving . Supports the creation of standardized clinical trial tools, processes and SOPs. May be responsible for serve as a resource during internal or external audits and regulatory inspections of the TMF. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.


Acquires job skills and learns company policies and procedures to complete routine tasks. Works on assignments requiring limited judgment. Provides support to clinical research including, but not limited to, maintenance of documentation, clinical tracking and information retrieval. Assists in management of access and organization of the controlled clinical document storage on-site at Nektar or third-party providers, including ensuring the defined file structure is maintained. Assists with the exchange of TMF documents with external service providers. Maintains file QC schedule and perform periodic inventories of study/project TMFs to ensure completeness. Assists with off-site archiving activities (including budget, cataloguing process, and document retrieval). Assists in coordinating communications, correspondence and associated documentation. Performs duties such as, clinical form design, and filing of correspondence, lab reports, Clinical Monitoring Reports, and other study documents. Assists with document retrieval. Maintains and ensures all documentation are in a state of audit-readiness. Assist in collection, dissemination, and/or tracking of regulatory documents as required. Performs all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions.


Requires a minimum of a High School diploma. An Associates degree is a plus. Equivalent experience may be accepted. A minimum of 1 year industry experience working in the Pharmaceutical, Biotechnology or other related industry is highly preferred. Strong attention to detail is a must. Good communication skills both oral and written are a must. Good computer skills are required. Working knowledge of MS Word, Excel, and PowerPoint is required. Excellent organizational skills are required. Must have an ability to multi-task.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.