Sr. Clinical Documentation Specialist

San Francisco, CA, United States
Apr 16, 2019
Biotech Bay
Required Education
High School or equivalent
Position Type
Full time
Position Overview

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.

Completes tasks in creative and effective ways. Works on assignments requiring considerable judgment and initiative. Understands implications of work and makes recommendations for solutions. Determines methods and procedures on new assignments. Provides support to clinical research including, but not limited to, maintenance of documentation, clinical tracking and information retrieval. Manages access and organization of the controlled clinical document storage on-site at, including ensuring the defined file structure is maintained. Manages 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). Serves as key central contact for 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. Also, responsible for document retrieval. Maintains and ensures all documentation are in a state of audit-readiness. Responsible for collection, dissemination, and/or tracking of regulatory documents as required. Coordinates study logistics, documents, drug shipments, enrollment and safety. Performs all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions, and appropriate industry and Good Clinical Practices standards. Supports other projects as assigned. May provide guidance to junior staff.

Requires a minimum of a High School diploma. An Associates degree is a plus. Equivalent experience may be accepted. Typically 6 years industry experience working in the Pharmaceutical, Biotechnology or other related industry is required. 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.