Sr. Clinical Project Associate

Location
San Francisco, CA, United States
Posted
Dec 18, 2018
Ref
3414-530-2019
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Assists with all aspects of the design, planning, and implementation of clinical research projects.

Participates in and coordinates the protocol and final clinical study report writing efforts. Assist with the 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. Maintains a high level of professional expertise through familiarity with clinical literature and participates in project team meetings. Periodically travels to field sites to supervise and coordinate clinical studies. May assist in drafting clinical study protocols. May lead the execution of specific clinical study deliverables with the support of the Clinical Trial Manager as well provide 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. 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 with site and other internal departments. Provides support to the Clinical Trial Manager 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. May assist or lead with site submission of essential documents. Collaborates with Documentation Specialist to set up and maintain the Trial Master File (TMF). 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. Assist with the distribution and control of clinical, regulatory and study-related documents (e.g., protocols, informed consents). Maintains project documents, i.e., confidentiality agreements, clinical consultant agreements and service agreements. 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. Assist with ordering and the maintenance of clinical supplies for sites and the study team. Assists with the maintenance of a device/drug inventory system and tracks distribution of clinical supplies to site or third party packager. Coordinates and assists in review and approval of labels for clinical product(s). Assists with the design of Case Report Forms (CRFs). Assists with the creation of project specific tools, instructional manuals, protocols and informed consents. Assists with the coordination and meeting logistics for clinical advisory, consultant or expert meetings and study-related internal and external meetings. Provides input on agendas. May support and mentor new staff orienting to the CPA role. May maintain meeting minutes, create materials and liaise with meeting planners.

A Bachelors degree in a scientific discipline is required. RN or BSN degree is highly desired. Equivalent experience may be accepted. A minimum of 4 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, GCP and GMP 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, Lotus notes is a plus. May involve 10-20 % travel as required to clinical sites to perform study monitoring, including drug accountability, regulatory document review and other related tasks. Works on project objectives to meet timelines and deliverables. Maintains the budget planning system to track specific and defined clinical projects goals and deliverables. May act as backup Clinical point person for the JD Edwards MRP system.

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.