- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key… more
- Merck & Co. (Rahway, NJ)
- … Clinical Research Associate - Northeast Region (Remote) With support of Senior Clinical Research Associate (SrCRA/CRA) and/or CRA Manager, acts as primary ... site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.Develops strong site relationships and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Authority Interactions Publications- May contribute to addressing questions about medical decisions, clinical data review, protocol deviations, etc., and/or ... areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical ...of clinical sections of study-level documents (eg, protocol , amendments)- Reviews safety data to mitigate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and associated documents (writing of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus on patient safety and ... function. He/she will be responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior...of high-quality clinical trial protocols, review of clinical data and Clinical Study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol… more
- Eisai, Inc (Nutley, NJ)
- …groups in support of multiple early clinical development studies. PCS / Clinical Protocol Development - reviews whole protocols and interfaces with ... we want to hear from you. Job Summary The Senior Manager, Translational Science Biostatistics will be expected to...to proactively address issues to ensure high quality study data (as needed). Clinical Study Report - provides… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...This includes leading processes and technology improvements to link Clinical trial site needs, Finance and Supply forecasts that… more
- Mindlance (Atlanta, GA)
- Job Title: Senior Biostatistician II Job Location: REMOTE MUST HAVES/ Top Skills: . Lead level experience to react to FDA questions. . Experience on ADaM Datasets ... and scientific . activities of team members across multiple complex projects. Provides senior -level oversight of statistical aspects in the design and analysis of … more
- DivIHN Integration Inc (San Diego, CA)
- …please contact one of our Talent Specialists Rashi at 630 847 1027 Title: Clinical Research Associate (CRA) - B Location: San Diego, CA Duration: 5 Months ... paid at Time and a Half. Member of the clinical team responsible for conducting Phase I-IV single or...to Federal Regulations and ICH guidelines. Responsible for assisting senior staff in planning study conduct, designing case report… more
- Spectraforce Technologies Inc (Alameda, CA)
- Job Title: Clinical Research Associate - B Location: Alameda, CA (94502) Shift - 8:00am to 5:00pm Duration: 6 Months with possible extension Payrate starts at $55/hr ... on W2 Job Responsibilities: Member of the clinical team responsible for conducting Phase I-IV single or...to Federal Regulations and ICH guidelines. Responsible for assisting senior staff in planning study conduct, designing case report… more
- George Washington University (Washington, DC)
- …Department of Environmental and Occupational Health is looking for a laboratory Senior Research Assistant to join our molecular epidemiology and microbiome research ... is to quantify the contribution of bacteria from food animals to human clinical infections by characterizing the genetic relatedness of strains from food and human… more
- Mindlance (Atlanta, GA)
- …skills * Excellent understanding of the regulatory issues associated with the reporting of clinical data in the submission process * Great consultative skills * ... protocol development. Review protocols for completeness, appropriateness of clinical design and sound statistical analysis. Contributes to writing appropriate … more
- George Washington University (Washington, DC)
- …professional activities as you join our research teams. Research guides, coding and data management solutions as well as extensive online journals from GW Libraries ... Principal Investigator, the postdoc will participate in analyzing and interpreting data , publishing the results, and representing the research team at conferences… more
- George Washington University (Washington, DC)
- …planning and executing events, scheduling rooms, ordering equipment, processing payments, data entry, preparing reports, and similar duties. Often these roles are ... tasks that are routine, and under the general supervision of more senior personnel within the department, or program.Duties include:Record Management and Compliance… more
- George Washington University (Washington, DC)
- …with guidance from Dr. Liu and collaborators to collect metagenomic/transcriptomic/proteomic/metabolomic data from clinical studies and in vitro experiments. ... to infectious diseases. EOH is searching for a full-time Senior Research Associate to join our microbiome and molecular...such as inventory, equipment maintenance, and lab clean-up, Compile data and perform preliminary data analysis in… more
- Guidehouse (Bethesda, MD)
- …submissions and status of approvals. + Assist researchers prepare, review, and submit clinical data to monitoring agencies. + Assist researchers review and ... Will Do** **:** We are currently searching for a Clinical Research Protocol Navigator. The primary role...NINDS Intramural Research Program. + Prepare draft documents for senior staff review. + Coordinate with other offices eg,… more
- MD Anderson Cancer Center (Houston, TX)
- Senior Coordinator, Clinical Studies - Thoracic-Head & Neck Medical Oncology JOB SPECIFIC COMPETENCIES Protocol Management -Independently performs ... -Works with the Nurse Managers to ensure consistency between protocol database data and source documentation and...clinical research activities are in accordance with IRB protocol and/or per grant specifications. - Participate in … more
- University of Maryland, Baltimore (Baltimore, MD)
- …while participants are in a study. * Performs other duties as assigned. * Senior Clinical Research Assistant* * Responsible for facilitating and coordinating ... *Other:*May consider a combination of directly related experience and education. * Senior Clinical Research Assistant* *Education:*Bachelor's degree in a… more
- Editas Medicine (Cambridge, MA)
- …equitable future. Position Summary Reporting to the VP of Biometrics, the Director/Sr. Director, Clinical Data Management is responsible for all clinical ... and excellent people leadership skills. Key Responsibilities: + As the Director/Sr. Director, Clinical Data Management, you will be responsible for: + Provide… more
