Sr. Clinical Trial Assistant

Location
San Francisco, CA, United States
Posted
Oct 06, 2018
Ref
3358-530-NB
Hotbed
Biotech Bay
Required Education
Associate Degree
Position Type
Full time
Position Overview

Assist in the operational and logistical aspects of clinical trials according to ICH-GCP and internal Nektar procedures.

Support the clinical trial team, ensuring that all essential documentation is collected, maintained and filed during the study. This job 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. Provide support to the clinical trial team with many of the tasks involved with the smooth running of clinical trials in compliance with Nektar processes. Collaborate with the clinical trial team in taking action to address issues as they arise. Set up and maintain Trial Master Files and ensuring all relevant study documents are filed and archived based on the appropriate guidelines. Review existing Paper or electronic Trial Master Files, collect outstanding documents and archive after study is completed. Help manage clinical, regulatory and study-related essential documents such as study protocols, Informed Consent Forms, etc. Interact with Investigator sites for activities such as to collect relevant documentation and study materials. Liaise with contract organizations, vendors and other suppliers of project support services to ensure study deliverables are met (i.e., contribute to documentation, processes and set-up activities to facilitate efficient working and effective partnerships with external groups). Provide input on agendas, maintain meeting minutes, create materials, liaise with meeting planners and coordinate logistics for internal or external meetings. Identify areas for process or technology improvements with regard to tasks within the role. Assist in the ordering of clinical trial supplies. May accompany clinical trial team on co-monitoring visits to observe and assist at site selection, site initiation, site monitoring, and closeout visits. Performs all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions, and appropriate industry standards and Good Clinical Practices. Supports other projects as assigned.

An Associates degree is a preferred with a Bachelors degree strongly desired. Equivalent experience may be accepted. A minimum of 4 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 and demonstrated ability to manage projects are required. Must have the ability to multi-task and effectively solve problems. Fluent English required. Solid understanding of clinical drug development is preferred.

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.