Clinical Project Associate

Location
San Francisco, CA, United States
Posted
Oct 13, 2020
Ref
5253-530-R
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Nektar has an exciting opportunity for a Clinical Project Associate to join their Development Operations Team.

Must meet all requirements for Clinical Trial Assistant position and have demonstrated proficiency in all relevant areas. Under supervision, assists with conduct of pre-study, initiation, and interim clinical study monitoring visits. Coordinates activities of clinical site to ensure compliance with protocol and overall clinical objectives. Communicates and collaborates with functional groups to ensure efficient management of study activities. Supports the clinical team in the conduct of the clinical trial. May manage clinical vendors. Maintains a high level of professional expertise through familiarity with clinical literature and participates in project team meetings. May travel to coordinate clinical study activities. May assist in drafting clinical study protocols and other study documents.

Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Coordinates study-related activities both internally and externally. Provides support to the Clinical Trial Manager/Clinical Trial Lead with study-related tasks to ensure efficient execution of clinical trials. Liaise with contract organizations, vendors and other suppliers of project support services to ensure study deliverables are met. Assists with pre-study, initiation, interim monitoring and close-out of a clinical study. Assists with site communication and problem solving. Assists site with submission of essential documents. May assist in data review and query reconciliation. Provides monthly study updates to the appropriate internal stakeholders as required. Maintains internal Clinical Operations databases and document repositories. Collaborates with Documentation Specialist to set up and maintain the Trial Master File (TMF). Ensures collection and review of site's essential documents. Effectively maintains the TMF, ensuring it is complete, accurate and up to date throughout the life cycle of the clinical study and assists with archival of the TMF when the study is complete. Assists with distribution and control of clinical, regulatory and study-related documents (e.g., protocols, informed consents). Maintains all aspects of documentation on department database/team rooms. Helps to ensure compliance with regulatory and Good Clinical Practices (GCP) requirements prior to shipment of clinical supplies. Assists in ordering and maintenance of clinical supplies for sites and the study team. Assists with the maintenance of a drug inventory system and tracks distribution of clinical supplies to site or third party packager. May assist with the creation of project specific tools, instructional manuals, protocols and informed consents. Assists with the coordination and logistics of team meetings, keeps agenda and meeting minutes. May involve 10-20 % travel as required to support clinical studies. Works on project objectives to meet timelines and deliverables. Other duties as assigned.

A Bachelors degree in a scientific discipline is required. RN or BSN degree is highly desired. Equivalent experience may be accepted. A minimum of 2 years experience in the Pharmaceutical, Medical Products industry, pharmaceutical product development or pharmaceutical formulations development is required. Must have demonstrated problem solving abilities. Strong organizational skills are required. Strong written and verbal communication skills are required. Knowledge of FDA regulatory, ICH, and GCP requirements is required. Must be willing to work as part of a team. Must have demonstrated good interpersonal skills. Good computer skills are required. Working knowledge of MS word, Excel, Power point, is required.

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.