Avid Bioservices Inc (CDMO)

[biopharm]

Job Posting Update : Peregrine/Avid : 39 total now

#15 just added...... all 38 prior jobs and their descriptions can be seen on prior post
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Current Job Listings

Below is a list of the current openings with our company. Click on the job title to learn more about the opening.

1) Bio-Process Engineer

PPHM - Process SciencesCA, USA31-Dec-2015Full Time

2) Biotech Environmental Monitoring Technician - Microbiological Quality Control

Avid - QC MicroTustin, CA, USA31-Dec-2015Full Time

3) Business Systems Analyst

PPHM - Information TechnologyTustin, CA, USA31-Dec-2015Full Time

4) Clinical Data Specialist

PPHM - Clinical OPSTustin, CA, USA31-Dec-2015Full Time

5) Clinical Project Manager

PPHM - Clinical OPSTustin, CA, USA31-Dec-2015Full Time

6) Clinical Research Scientist

PPHM - Clinical OPSTustin, CA, USA31-Dec-2015Full Time

7) Clinical Trial Manager/Sr. Manager

PPHM - PPHM - Clinical ResearchTustin, CA, USA31-Dec-2015Full Time

8) Department Assistant

Avid - ManufacturingTustin, CA, USA31-Dec-2015Full Time

9) Director, Clinical Quality Assurance

PPHM - QualityTustin, CA, USA31-Dec-2015Full Time

10) Director, Quality Control - Biologics

Avid - Quality ControlTustin, CA, USA31-Dec-2015Full Time

11) Director/Sr. Director, Quality Assurance

PPHM - QualityTustin, CA, USA31-Dec-2015Full Time

12) ERP Manager, Dynamics AX

PPHM - Information TechnologyCA, USA31-Dec-2015Full Time

13) Housekeeping/Custodian

Avid - FacilitiesTustin, CA, USA31-Dec-2015Full Time

14) Immunoassay Development Associate

PPHM - Process SciencesTustin, CA, USA31-Dec-2015Full Time


15) In-House Clinical Research Associate -most recent addition

PPHM - Clinical OPSCA, USA31-Dec-2015Full Time


16) In-Vitro Lab Technician

PPHM - OperationsTustin, CA, USA31-Dec-2015Full Time

17) Logistics Supervisor - Avid

Avid - Materials ControlTustin, CA, USA31-Dec-2015Full Time

18) Mammalian Cell Culture Research Associate

PPHM - Process SciencesTustin, CA, USA31-Dec-2015Full Time

19) Manufacturing Associate/Sr. Associate - Downstream

Avid - ManufacturingTustin, CA, USA31-Dec-2015Full Time

20) Manufacturing Associate/Sr. Associate - Upstream Cell Culture

Avid - ManufacturingTustin, CA, USA31-Dec-2015Full Time

21) Manufacturing Supervisor - Biotech Downstream

Avid - ManufacturingTustin, CA, USA31-Dec-2015Full Time

22) Manufacturing Supervisor - Biotech Upstream

Avid - ManufacturingTustin, CA, USA31-Dec-2015Full Time

23) Manufacturing Technician - Cleanroom Escort (Biotech)

Avid - ManufacturingTustin, CA, USA31-Dec-2015Full Time

24) Medical Writer/Sr. Medical Writer

PPHM - Reg AffairsTustin, CA, USA31-Dec-2015Full Time

25) QC Analyst - Avid

Avid - Quality ControlTustin, CA, USA31-Dec-2015Full Time

26) Quality Engineer - Avid

Avid - Quality ControlTustin, CA, USA31-Dec-2015Full Time

27) Research Associate - Downstream

PPHM - Process SciencesTustin, CA, USA31-Dec-2015Full Time

28) Scientific Writer (Process)

PPHM - Process SciencesTustin, CA, USA31-Dec-2015Full Time

29) Sr. Maintenance Technician

Avid - FacilitiesTustin, CA, USA31-Dec-2015Full Time

30) Sr. Manager, Commercialization Development

PPHM - Business DevelopmentCA, USA31-Dec-2015Full Time

31) Sr. Protein Characterization Scientist

PPHM - Process SciencesTustin, CA, USA31-Dec-2015Full Time

32) Sr. QA Specialist/QA Specialist - Compliance

Avid - Quality AssuranceTustin, CA, USA31-Dec-2015Full Time

33) Sr. QA Specialist/QA Specialist - MQA

Avid - Quality AssuranceTustin, CA, USA31-Dec-2015Full Time

34) Sr. QC ELISA Chemist

PPHM - Process SciencesTustin, CA, USA31-Dec-2015Full Time

35) Sr. Quality Control Analyst

Avid - Quality ControlTustin, CA, USA31-Dec-2015Full Time

36) Sr. Specialist, Clinical Supplies

PPHM - Clinical OPSCA, USA31-Dec-2015Full Time

37) Sr. Specialist, QA - Audit

Avid - Quality AssuranceTustin, CA, USA31-Dec-2015Full Time

38) System Administrator, Dynamics AX

PPHM - Information TechnologyTustin, CA, USA31-Dec-2015Full Time

39) Validation Engineer

Avid - ValidationsTustin, CA, USA31-Dec-2015Full Time



http://peregrineinc.applicantpro.com/jobs/

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In-House Clinical Research Associate

Jobs
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27-Jul-2015 to 31-Dec-2015 (PST)
Clinical OPS
CA, USA
Salary
Full Time

The In-House Clinical Research Associate will support clinical research teams to facilitate the successful and timely conduct of clinical trials, build relationships and effectively communicate ideas and results. Activities may include investigative site recruitment, feasibility, essential document collection and review, status tracking and in-house site management activities.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Collect, disseminate and track regulatory documents as required.
• Review regulatory documents from study sites; ensure completeness and accuracy.
• Coordinate review of legal documents including clinical trial agreements and insurance.
• Develop study tools and guidelines to be utilized by study sites.
• Perform general administrative functions such as clinical trial tracking, provide logistical support to one or more study management teams (SMTs), schedule meetings for clinical staff and tracking, and manage distribution of non-clinical supplies throughout the course of the study.
• Track and maintain study information and reports on study progress including weekly update of study dashboard, maintenance of clinical study website and coordination of the study newsletter.
• Maintain study listings on www.clinicaltrials.gov and other similar trial registries.
• Will be responsible for Trial Master File (TMF) Management, i.e. maintain and ensure the completeness of the study level TMF in accordance with established file structure and provide support in filing documents outside the study level TMF.
• Maintain and ensure all documentation is in a state of audit-readiness.
• Coordinate communication for defined tasks and tracking information between the study team and vendor.
• Design and implement templates and/or systems, for example, databases, logs and spreadsheets for tracking essential study milestones, study specific information and key data related to activities with third party vendors.
• Assist the CTM/CRA by preparing lists of missing essential documents, clinical supply inventory lists and other actionable items.
• Prepare site regulatory and pharmacy binders for in-house Peregrine clinical studies.
• Prepare IRB submissions and track/complete IRB renewals.
• Manage assignment of investigational site numbers.
• May serve as a liaison between contracted research organizations, field sites, investigators, study coordinators, pharmacists, staff members, etc.
• Assist in preparation for regulatory audits or partnering discussions.
• Identify logistical and operational issues that arise during study execution and work with senior CRA/clinical management to develop solutions.
• Identify and contribute to areas of best practice and process improvement.
• Support other clinical and regulatory staff as required.
• May mentor junior CRAs and/or clinical trial assistants.

QUALIFICATIONS

• A Bachelor's degree in a scientific discipline from a four-year college or university or RN is required while an advanced degree is a plus.
• Must have a minimum of two years of experience in Clinical Operations or similar department with a pharmaceutical company.
• Customer service orientation is essential.
• Excellent interpersonal and organizational skills and attention to detail is required.
• Must have the ability to build and maintain positive relationships with management, peers, clinical sites and vendors.
• Thorough knowledge and understanding of FDA regulations and ICH/GCP guidelines is required.
• Prior experience in oncology and Clinical Research Certification (SoCRA or ACRP) is preferred.
• Must be able to travel domestically by land and/or air up to 10% of the time.

RELOCATION AVAILABLE

Please note this position is based in Orange County, CA and is a full time onsite role. Competitive relocation assistance within the continental USA will be provided for well-qualified individuals.

EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER

Peregrine Pharmaceuticals and Avid Bioservices do not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran.