Sr. Clinical Project Associate

Location
San Francisco, CA, United States
Posted
Jan 10, 2021
Ref
5253-530-R
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

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

Assists with all aspects of the design, planning, and implementation of clinical research projects. Assist with the conduct of pre-study, initiation, and interim clinical study monitoring visits and oversight. Coordinates activities of clinical studies to ensure compliance with protocol and overall clinical objectives. 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 study documents. May lead the execution of specific clinical study deliverables with the support of the Clinical Trial Manager. Provides updates to the clinical study team as appropriate. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Oversees selected vendors. Under supervision may serve as the key operational contact for internal and external stakeholders. Communicates and collaborates with functional groups to ensure efficient management of study activities. Proactively identifies potential operational challenges and in collaboration with Clinical Trial lead provides solutions to ensure study execution remains on track.

Works on complex problems in which analysis of situations or data requires in in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Coordinates study-related activities both internally and externally. Provides support to the study team 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. Ensures collection and review of site's essential documents are current and executed per CFR regulations. 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 the 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 with ordering and the maintenance of clinical supplies for sites and the study team. May assist with tracking distribution of clinical supplies to site or third party packager. Assists with the creation of project specific tools, instructional manuals, protocols and informed consents. Assists with the coordination and meeting logistics for internal and external meetings. Provides input on agendas and keeps minutes. May support and mentor new staff orienting to the CPA role. May involve 10-20 % travel as required to support clinical studies. Works on project objectives to meet timelines and deliverables. Other duties as assigned. Supports study drug planning and shipping activities. Provides monthly study updates to the appropriate internal stakeholders. Maintains internal Clinical Operations databases and document repositories.

A Bachelors degree in a scientific discipline is required. RN or BSN degree is highly desired. Equivalent experience may be accepted. A minimum of 5 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.