Clinical Scientist/Operations Specialist »

3 weeks ago

San Jose, United States Anixa Biosciences, Inc. Full time

Clinical Scientist/Operations Specialist

The Clinical Scientist/Operations Specialist is responsible for providing operational expertise to support the day-to-day execution of clinical trials, to follow established SOPs, GCP and applicable regulatory requirements in the execution of all activities and to proactively identify and resolve operational project issues.

Responsibilities:

* Participates in selection, management and oversight of external vendors and develops vendor
* specifications; reviews vendor reports, budgets, and metrics; acts as liaison between vendors and
* Participates in study design and execution by contributing operational experience: provides input into protocol, ICF, CRF design, monitoring conventions, edit checks and vendor specifications; assists with study or site feasibility process; posts and maintains study-related information on external websites when applicable.
* Coordinates specified clinical trial meetings (eg, investigator meetings, DSMB meetings, study team meetings, CRO meetings) by arranging logistics, preparing necessary materials and recording and distributing minutes.
* Maintains ongoing communication with vendors and site staff to resolve issues (eg, data queries and
* data entry, study management, protocol deviations), support the site staff, oversee the efficient conduct of the trial, and ensure continued compliance.
* Ensures necessary study supplies are available per study timelines: sources clinical trial supplies through external vendors (eg, lab kits); manages, reviews and tracks drug shipment, destruction, and return; coordinates internal lab sample supply set-up and shipment.
* Assures trials are conducted on time and budget, while fully compliant with ICH GCP and the SOPs in
* Conducts on-site visits consistent with the applicable Clinical Monitoring Plan and SOPs for site
* qualification, site initiation, routine monitoring, site close-out and other site visits as requested and writes confirmation letters, follow-up letters and site visit reports that conform with guidelines and timelines stated in the applicable Clinical Monitoring Plan and SOPs.
* Stays up-to-date with industry developments and trends to identify opportunities for process
* Serves as the clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., Institutional Review Board (IRB), sites)
* Performs other tasks, as assigned by the manager/designee to promote the efficient conduct of the

Requirements:

* Degree in life sciences, nursing, or related field; Advanced degree (Pharm , Ph.D., Master's) preferred At least 5 years of experience in clinical operations, oncology experience preferred
* Strong knowledge of FDA regulations and guidelines Excellent communication skills, both written and verbal Ability to work independently and as part of a team
* Strong problem-solving and critical thinking skills
* Willingness to travel as needed for site visits and meetings

To apply, please submit your CV to

  • Clinical Lab Scientist CLS

    17 hours ago

    San Lucas, United States Clinical Management Consultants Full time

    A reputable hospital in California is actively interviewing for an experienced Clinical Lab Scientist CLS to join their team. A qualified candidate must have the following: Current California Clinical Laboratory Scientist (CLS) license At least 1 yea Clinical, Scientist, Lab, Lab, Patient Care, Healthcare, Staffing

  • Clinical Lab Scientist Specialist

    5 days ago

    San Francisco, United States University of California San Francisco Full time

    The CLS Specialist will be responsible for all work assigned in all areas of the Clinical Laboratory including routine procedures, method improvement and development and evaluation. All work performed is to be completed within a required time frame ensuring shortest turnaround time as it relates to patient care. All work is to be accurately and...

  • Lead Chemistry Clinical Laboratory Scientist CLS

    23 hours ago

    San Pablo, United States Clinical Management Consultants Full time

    A wonderful career opportunity for Lead Chemistry Clinical Laboratory Scientist CLS is now available with a reputable and prestigious Hospital in the beautiful, sunny and coastal San Francisco Bay Area in California. If you enjoy a fun lifestyle in a Chemistry, Clinical, Laboratory, Scientist, Chemist, Clinic, Healthcare, Staffing

  • Lead Hematology Clinical Laboratory Scientist CLS

    21 hours ago

    San Pablo, United States Clinical Management Consultants Full time

    A wonderful career opportunity for Lead Hematology Clinical Laboratory Scientist CLS is now available with a reputable and prestigious Hospital in the beautiful, sunny and coastal San Francisco Bay Area in California. If you enjoy a fun lifestyle in Clinical, Hematology, Scientist, Laboratory, Clinic, Lead, Healthcare, Staffing

  • Lab Specialist

    20 hours ago

    San Francisco, United States St Marys Medical Center Full time

    Cure Healthcare is seeking a Lab Specialist - Clinical Lab Scientist CLS for positions in San Francisco, California. Current California license and AHA BLS required and additional certifications related to this specialty. This shift is 5x8 Days. Required: 2 years of recent experience in Clinical Lab Scientist CLS. Please inquire for specific job details and...

  • Lab Specialist

    2 weeks ago

    San Francisco, United States St. Mary's Medical Center (West Virginia) Full time

    Cure Healthcare is seeking a Lab Specialist - Clinical Lab Scientist CLS for positions in San Francisco, California. Current California license and AHA BLS required and additional certifications related to this specialty. This shift is 5x8 Days. Required: 2 years of recent experience in Clinical Lab Scientist CLS. Please inquire for specific job details and...

  • Clinical Scientist II

    3 weeks ago

    South San Francisco, United States Bayside Solutions, Inc. Full time

    Bayside Solutions is seeking a Clinical Scientist II to be part of our client' s team in South San Francisco. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leadi Clinical, Scientist, Science, Data, Operation, Clinic, Technology, Staffing

  • Staff Scientist

    2 days ago

    San Jose, United States Brains Workgroup, Inc. Full time

    Staff Scientist One of our clients, medical imaging services company is looking for an talented Staff Scientist** Must be authorized to work in US for ANY EMPLOYER.   No H1 Visa support for this position. The Location is San Jose, CA.This is on-site role. Permanent position with great benefits. Staff Scientist will lead the optimization of imaging control...

  • Scientist

    22 hours ago

    San Jose, United States Biofire Diagnostics Full time

    We are seeking a Microbiologist with experience in Research and Development. You will be a key contributor and critical to the success of the company. As part of the Microbiology team, you will be responsible for designing, documenting, and testing both instruments and consumables to support the company's product lines. You will be responsible for executing...

  • PV Clinical Scientist

    3 weeks ago

    San Mateo, United States R&D Partners Full time

    Our biopharmaceutical client in the San Francisco Bay Area is recruiting for a PV Clinical Scientist. Overview: Complete patient safety monitoring and tracking in accordance with pharmacovigilance and related standards, regulations and Standard Opera Clinical, Scientist, Clinic, Healthcare, Staffing

  • Clinical Laboratory Scientist

    2 weeks ago

    San Antonio, United States CHRISTUS Health Full time

    CHRISTUS Children's and Santa Rosa Hospital are hiring Clinical Laboratory Scientists at the following locations:* Children's* Westover Hills* Medical center* Alamo Heights* New Braunfels* San MarcosThe Clinical Laboratory Scientist is responsible for the direct oversight of daily operations and testing of assigned section including staffing, procedures,...

  • Clinical Laboratory Scientist

    3 weeks ago

    San Antonio, United States CHRISTUS Health Full time

    CHRISTUS Children's and Santa Rosa Hospital are hiring Clinical Laboratory Scientists at the following locations:* Children's* Westover Hills* Medical center* Alamo Heights* New Braunfels* San MarcosThe Clinical Laboratory Scientist is responsible for the direct oversight of daily operations and testing of assigned section including staffing, procedures,...

  • Scientist

    20 hours ago

    San Jose, United States Biomerieux S.A. Full time

    Description We are seeking a Microbiologist with experience in Research and Development. You will be a key contributor and critical to the success of the company. As part of the Microbiology team, you will be responsible for designing, documenting, and testing both instruments and consumables to support the company's product lines. You will be responsible...

  • Scientist

    20 hours ago

    San Jose, United States Biofire Diagnostics, LLC Full time

    Want to see more? Find all job opportunities for both BioFire and bioMerieux worldwide by clicking here. Description We are seeking a Microbiologist with experience in Research and Development. You will be a key contributor and critical to the succes Scientist, Microbiology, Operations, Microbiologist, Manufacturing, Technology, Microbiology, Biology

  • Scientist

    7 days ago

    San Jose, California, United States bioMerieux SA Career Site - MULTI-LINGUAL Full time

    Description We are seeking a Microbiologist with experience in Research and Development. You will be a key contributor and critical to the success of the company. As part of the Microbiology team, you will be responsible for designing, documenting, and testing both instruments and consumables to support the company's product lines. You will be responsible...

  • Scientist

    6 days ago

    San Jose, United States bioMerieux SA Career Site - MULTI-LINGUAL Full time

    Description We are seeking a Microbiologist with experience in Research and Development. You will be a key contributor and critical to the success of the company. As part of the Microbiology team, you will be responsible for designing, documenting, and testing both instruments and consumables to support the company’s product lines. You will be responsible...

  • Clinical Laboratory Scientist

    2 weeks ago

    San Antonio, TX, United States CHRISTUS Health Full time

    CHRISTUS Children's and Santa Rosa Hospital are hiring Clinical Laboratory Scientists at the following locations: * Children's * Westover Hills * Medical center * Alamo Heights * New Braunfels * San Marcos The Clinical Laboratory Scientist is responsible for the direct oversight of daily operations and testing of assigned section including staffing,...

  • Clinical Specialist | Urology

    3 weeks ago

    San Jose, United States Boston Scientific Corporation Full time

    The Clinical Specialist position requires someone with a strong clinical aptitude that can work in a team environment to support Territory Managers by covering Prosthetic Urology procedures in the Operating Room and Physician Clinics. In addition, he Clinical, Specialist, Health, Medical Technician, Healthcare, Territory Manager, Manufacturing

  • Clinical Laboratory Scientist

    2 weeks ago

    San Antonio, TX, United States CHRISTUS Health Full time

    CHRISTUS Children's and Santa Rosa Hospital are hiring Clinical Laboratory Scientists at the following locations:* Children's* Westover Hills* Medical center* Alamo Heights* New Braunfels* San MarcosThe Clinical Laboratory Scientist is responsible for the direct oversight of daily operations and testing of assigned section including staffing, procedures,...

  • Director of Clinical Operations

    3 weeks ago

    San Antonio, United States Worldwide Clinical Trials Full time

    Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on...