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Nektar Therapeutics

    Nektar Therapeutics is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates that utilize its PEGylation and polymer conjugate technology platforms, which are designed to improve the benefits of drugs for patients. Its product pipeline consists of drug candidates across a number of therapeutic areas, including oncology, pain, anti-infectives, anti-viral and immunology. Nektar's research and development activities involve small molecule drugs, peptides and oth... Read More

Address      455 Mission Bay Boulevard South San Francisco, CA 94158
Website      www.nektar.com/
Holding      No Holding Details

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Clinical Research Associate

Designs, plans, and implements clinical research projects. Participates in and coordinates the protocol and final clinical study report writing efforts. Conducts 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. Drafts clinical study protocols.

Responsibilities
Works on extremely complex problems in which analysis of situations for data requires an evaluation of intangible variables. Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Conducts pre-study, initiation, interim monitoring of a clinical study. Responsible for site communication and problem solving. Responsible for collection and review of site's essential documents. Ensures compliance with ICH and GCP prior to shipment of clinical supplies. Designs Case Report Forms (CRFs). Coordinates study-related activities with site and other departments. Creates project specific tools, instructional manuals, protocol and model consents. Periodic travel to clinical sites to perform study monitoring, including drug accountability, regulatory document review and other related tasks. Manages project objectives to meeting timelines and deliverables. Initiates and oversees a budget planning system to track specific and defined clinical projects goals and deliverables across multiple programs. Manages all aspects of documentation on department database/team rooms. Effectively maintains the clinical trial filling system for all studies. Acts as backup Clinical point person for the JD Edwards MRP system. 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). Maintains project documents, i.e., confidentiality agreements, clinical consultant agreements and service agreements. Assists with the coordination and meeting logistics for clinical advisory, consultant, or expert meetings. May supervise the activities of junior CRAs.

Requirements
A Bachelors degree in a scientific discipline is required. RN or BSN degree is highly desired. Equivalent experience may be accepted. A minimum of 8 years experience in the Pharmaceutical, Medical Products industry, pharmaceutical product development or pharmaceutical formulations development is required. Previous supervisory experience is a plus. Must have demonstrated problem solving abilities. Strong organizational skills are required. Strong written and verbal communication skills are required. A thorough understanding 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.

Other Job Information

Vacancy type:

Full Time

Contact Mode:

not provided

Fax:

415.339.5300

Contact Name:

not provided

Job Duration:

not provided

Phone:

415.482.5300

Email:

nektarSF@nektar.com

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