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  1. Director/Sr. Director, Regulatory & Scientific Communications

    2013…..NOW HIRING in San Diego….Director/Sr. Director, Regulatory & Scientific Communications…..Ardea Biosciences/Astra Zeneca Ardea Biosciences, a wholly owned subsidiary of AstraZeneca, is headquartered in San Diego, CA. We are a biotechnology company focused on the development of small-molecule therapeutics for the treatment of serious diseases. The successful candidate will be responsible for managing and directing the medical writing function as well as producing documents for regulatory ...

  2. Senior Clinical Research Associate

    We are currently looking to hire Permanent Regional CRAs Job Description   The responsibility of a Clinical Research Associate (CRA) is to perform the clinical monitoring aspect of designated projects in accordance with applicable SOP and regulations. Responsibilities include performing clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection), collecting regulatory documentation (when required), performing qualification ...

  3. Senior GCP QA Manager/Associate

    Ardea Biosciences, a wholly owned subsidiary of AstraZeneca, is headquartered in San Diego, CA. We are a biotechnology company focused on the development of small-molecule therapeutics for the treatment of serious diseases. Ardea is seeking a GCP QA Manager/Senior Associate to join it's dynamic team. The successful candidate will provide consultation in interpretation of GCP regulations, guidelines, policies, and procedures; plan and conduct independent Good Clinical Practice (GCP) quality ...

  4. Regional Oncology CRA in Miami, FL

    This position is responsible for performing any/all of the following tasks and responsibilities, as well as any other tasks deemed appropriate by the Supervisor: Monitor activities at assigned clinical study sites to assure adherence to ICH GCPs, local regulatory requirements, TRIO Standard Operating Procedures (SOPs), Standard Guidelines (SGs), Instruction Manuals (IMs), study protocols and study-specific SGs/IMs, for multiple projects Conduct Pre-Study Site Visits (or calls), Study Initiation ...

  5. Regional Oncology CRA - San Diego, CA

     This position is responsible for performing any/all of the following tasks and responsibilities, as well as any other tasks deemed appropriate by the Supervisor:   Monitor activities at assigned clinical study sites to assure adherence to ICH GCPs, local regulatory requirements, TRIO Standard Operating Procedures (SOPs), Standard Guidelines (SGs), Instruction Manuals (IMs), study protocols and study-specific SGs/IMs, for multiple projects Conduct Pre-Study Site Visits (or calls), Study Initiation ...

  6. Oncologist - Early Stage Clinical Development - Houston, TX

    Develop and implement strategies focused on molecularly driven oncology programs integrating data from clinical trials, journals and medical records into biomarker development, discovery research, patient selection and clinical research. Collaborate with clinical personnel, research teams, academic institutions and other scientific professionals to drive the development of novel therapeutics. Qualifications: *** MD, MD-PhD or PhD in a relevant scientific field such as pathology, molecular biology ...

  7. Medical Director Discovery Strategies - Cancer Biology - San Diego, CA

    Strategic leader needed to oversee a program in cancer immunotherapy with a focus on translating findings from preclinical studies into the design and implementation of collaborative clinical trials. Shall: *** Lead the review, analysis and interpretation of study data to develop preclinical strategies for biomarker discovery *** Provide scientific expertise for evaluation of licensing opportunities *** Establish collaborations and interact with external clinical groups to drive the ...

  8. Biostatistics Consultant

    2013…..NOW HIRING….Biostatistics Consultant…..Ardea Biosciences/Astra Zeneca Ardea Biosciences, a wholly owned subsidiary of AstraZeneca, is headquartered in San Diego, CA. We are a biotechnology company focused on the development of small-molecule therapeutics for the treatment of serious diseases. Ardea is seeking an Associate Director, Analytical Sciences to join its’ dynamic team. The Biostatistics Consultant is responsible for providing input to statistical analysis plans, and executing on ...

  9. Regional Sr. CRA CA, AZ, NV, Utah, Oregon

       Sr. RCRA – West Coast – Oncology, Rheumatology, Diabetes Key Accountabilities   Ø  Assume the ability to meet the requirements of a CRA I and II with a high degree of proficiency and autonomy Ø  Shows solid understanding of therapeutic indications and study hypothesis. Ø  Act as an independent CRA Coordinator on complex or multiple projects, CRA Coordinator on smaller projects Ø  Represent function in external client meetings and presentations such as investigator meetings and bid defenses as ...

  10. Research Associate

    Our client assists customers in rapidly developing, manufacturing and commercializing point of care lateral flow, flow through and ELISA assays for any market segment. Our client develops products for markets as broad as clinical diagnostics, veterinary diagnostics, food science, and microbiology and operates under design controls and GMP as required. They are seeking a Research Associate who will be responsible for research and development of products from feasibility through clinical trials and ...

  11. Clinical Project Manager (Home Based)

     Clinical Operations Leader Responsible for coordinating the functional team members and their activities across all geographies, liaising with project leadership and the sponsor to ensure that the Global Research Operations deliverables (timeline, quality, productivity) are met. The ClinicalOperations Leader has overall accountability for the execution of the clinical operations strategy on the project. May act as Project Leader for projects involving a small number of services, where no Project ...

  12. SAS Programmer

    Looking for a qualified SAS Programmer (home based) Requirements include but are not limited to the following: BA/BS degree in computer science, statistics, biostatistics, mathematics or related field. MA/MS degree is desirable  3-5 years of programming and clinical research or related experience Must have database management, SAS or PL/SQL programming experience Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills ...

  13. Clinical Lab Scientist (CLS) #1265

    AltheaDx performs assay development and clinical testing services for biopharma customers and physicians. Our biopharma service menu covers early stage biomarker discovery through companion diagnostics development, clinical trials and regulatory submission to FDA. AltheaDx is bringing theranostics into clinical use. Please visit our website http://www.altheadx.com for additional details. Clinical Lab Scientist (CLS) The successful candidate will be responsible for performing assay validation, CLIA ...

  14. Diabetic Research Study For Females Age 18 - 50

    Accelovance is currently seeking females between the ages of 18-50 who have been diagnosed with Type 1, Type 2, or Gestational Diabetes to participate in a clinical research study. This study will be evaluating an investigational non-invasive diabetes screening device. The study will require one visit that will last approximately 2.5 Hours. Volunteers will be compensated for their participation. For more information please contact Accelovance at 619-291-2845

  15. Staff Scientist - Molecular Assay Development - San Diego, CA

    Leading diagnostic organization seeks Staff Scientist to design, develop, and validate novel molecular assays for laboratory testing. Hands on experience with the following required: *** Quantitative gene expression assays and assay platforms *** DNA array based molecular assay development *** Process development and optimization *** Verification and validation studies *** CLIA approved tests MS or PhD in a scientific field required. Well established company with documented history of ...

  16. Clinical Support Specialist

    Millennium Laboratories is the leading research-based clinical diagnostic company dedicated to improving the lives of people suffering from pain and/or addiction. We provide healthcare professionals with the medication monitoring and drug detection services, clinical tools, scientific data and education helping to personalize treatment plans to improve clinical outcomes and patient safety. We provide customized drug testing services for healthcare professionals to help them to mitigate the abuse ...

  17. Specimen Resolution Specialist - Clinical Lab

    Millennium Laboratories is the leading research-based clinical diagnostic company dedicated to improving the lives of people suffering from pain and/or addiction. We provide healthcare professionals with the medication monitoring and drug detection services, clinical tools, scientific data and education helping to personalize treatment plans to improve clinical outcomes and patient safety. We provide customized drug testing services for healthcare professionals to help them to mitigate the abuse ...

  18. Research Associate

    This position will perform a variety of research laboratory tasks and experiments under direct supervision. The Research Associate makes detailed observations, analyzes data and reports results. The Research Associate maintains laboratory equipment and inventory levels for laboratory supplies. This position will assist in writing reports, summaries and protocols. The associates in this position also perform limited troubleshooting of instruments. Position Responsibilities: 1. Assist with product ...

  19. QA Coordinator, Raw Materials

    Our client is a leading formulator and manufacturer of customized nutritional supplements. The Company's comprehensive partnership approach to client servicing is unique within the industry, combining clinical research, science-based formulation, advanced quality assurance testing methodologies, superior manufacturing and packaging capabilities and broad marketing experience to create nutritional products that are formulated to address specific health conditions. Summary Primarily responsible for ...

  20. Manufacturing Technician

    Our client is a privately held biopharmaceutical company focused on the research, development and commercialization of molecular transport agents. They are seeking a Manufacturing Technician II to join their team. This is a Contract to HIRE role and is accompanied by a competitive compensation package. Description of Duties: • Performs cGMP manufacturing of R&D, Pre-Clinical, and Clinical products. • Assembles, operates, cleans, and maintains production equipment. • Weighs, measures and checks ...

  21. Regulatory Medical Writer (home based)

    Must have written all of the following: NDA submissions, Protocols, Narratives, Case Report Studies, and Inform Consent forms   Write clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical ...

  22. Market Research Analyst

    Market Research Analyst will be responsible for researching and analyzing the company’s potential markets and competition. Will conduct primary and secondary market research studies, summarize the results and support marketing strategy and launch plans for a first-in-class oncology immunotherapeutic. Responsibilities: •Perform market research, including both primary and secondary research •Interface with consulting firms on conducting market research, delivering quality insights within the ...

  23. Scientist II, Metagenomics Specialist

    Candidate will evaluate a new DNA isolation protocol for its utility in metagenomics research and interact with the development team. This will include using standard molecular biology such as DNA isolation, cloning and PCR; nucleic acid detection assays using qPCR, next-generation sequencing, and other methods. Experience with both clinical and environmental samples is desired as is a published history in metagenomics research. Responsibilities: • Manage 1-2 FTEs • Plan and execute experiments, ...