Jobs
>
San Francisco

    Clinical Research Associate - San Francisco, United States - TalentBurst

    TalentBurst
    TalentBurst San Francisco, United States

    3 weeks ago

    Default job background
    Description
    Industry: Medical Devices
    Position: Clinical Research Associate with Ophthalmology Experience
    Location: Remote (However, candidates will need to be in specific states as they may occasionally have to go into the office
    Duration: 24 Months Contract
    Note : 3 days a week at the site. (Travel expense will be reimbursed)

    Preferred locations: CA- Northern California- Las Vegas, Phoenix (AZ), Chicago (IL), Cincinnati (OH), Boston (MA), FL, NC/SC, Austin, San Antonio (TX) & Atlanta (GA)

    Job Description:
    As a Contract CRA in ophthalmology, you will be responsible for monitoring and managing clinical trials, at the sites under your responsibility, related to eye diseases, ophthalmic treatments, and ophthalmic devices. You will ensure that these trials are conducted in compliance with international guidelines, local regulations, industry standards, and study protocols. This position is regionally based and involves working with multiple clinical trial sites across multiple protocols.

    Education and Experience:
    • Bachelor's degree in a related field (life sciences, nursing, etc.).
    • Previous experience as a Clinical Research Associate, preferably in ophthalmology or a related therapeutic area.
    • Knowledge of ophthalmic diseases, treatments, and related medical terminology, including ophthalmic devices.
    • Strong understanding of clinical research regulations and Good Clinical Practice (GCP) guidelines.
    • Excellent communication and interpersonal skills.
    • ttention to detail and the ability to work independently and as part of a team.
    • Willingness to travel as needed for on-site monitoring visits.
    • Certification as a Certified Clinical Research Associate / Professional (CCRA / CCRP) or similar credential is a plus.
    Roles and Responsibilities:

    1. Site Selection and Initiation:
    • ssist in the selection of investigative sites for clinical trials.
    • Conduct site initiation visits to verify that site staff is properly trained and delegated to perform protocol assessments, are familiar with regulatory requirements and understand proper handling and storage of ophthalmic drugs/devices.
    • Ensure recruitment strategies are in place to meet enrollment targets.
    • Confirm that the site meets the requirements to begin screening subjects.
    2. Monitoring and Site Management:
    • Conduct on-site and remote monitoring visits according to the protocol monitoring plan to ensure data quality and regulatory compliance.
    • Review source documents, case report forms, and patient records.
    • Verify the informed consent process is properly executed and adherence to the study protocol.
    • Ensure that instruments/equipment used in the clinical trials are correctly calibrated, maintained, and utilized according to the study protocol and regulatory standards.
    • Collaborate with the Clinical Operations Lead and Clinical Trial Team (CTT) to identify and resolve site quality or study execution issues.
    3. Regulatory Compliance:
    • Ensure that the clinical trial sites are compliant with applicable regulatory requirements (e.g., FDA, ICH, GCP, ISO) regarding ophthalmic drugs/devices.
    • Ensure that the study sponsor and Investigator Site File are maintained and audit-ready.
    • ssists sites and CTT with internal and external audit / inspection-related activities including preparation, defining CAPAs, and ensuring CAPA targets are met.
    4. Investigational Product (IP) and Clinical Supplies Oversight:
    • Verify subject qualification and correct IP was dispensed/implanted.
    • Ensure masking has been maintained, if applicable.
    • Confirm full reconciliation of IP at the site level.
    • Monitor drug / device-related safety and performance concerns and report them to the study sponsor.
    • Ensure proper handling, storage, and accountability of investigational drugs and/or devices.
    • Ensures appropriate clinical supplies are available, within the expiry date, and adequate for clinical trial.
    5. Data Management:
    • Verify data accuracy and completeness, including instrument/equipment generated data. Ensure data is securely stored.
    • Collaborate with the data management team to resolve data-related issues.
    6. Safety Reporting:
    • Ensure all safety issues are communicated and managed by the Principal Investigator according to regulatory and protocol requirements.
    7. Close-Out Visits:
    • Conduct close-out visits to ensure study documentation is complete, finalize data collection, and ensure all study-related activities are completed by the study protocol and regulatory requirements.
    • Review Investigator obligations.
    9. Documentation and Reporting:
    • Complete comprehensive and accurate monitoring reports, including site follow-up letters.
    • Ensure CTMS and eTMF are up-to-date and audit ready.
    TB_PH
  • Belcan

    Research Associate

    1 week ago

    Belcan Emeryville, United States

    Research Associate · Job Number: · Category: Research Scientist · Description: Job Title: Research Associate · Pay Rate: Starting at $48 / hr depending on experience · Location: Emeryville, CA · Area Code: 510 · ZIP Code: 94608 · Start Date: Right Away · Shift: 1st shift ...

  • University of California San Francisco

    Staff Research Associate

    2 weeks ago

    University of California San Francisco San Francisco, United States

    A Staff Research Associate 1 (SRA 1) position is available in the laboratory of Dr. Ophir Klein in the Program in Craniofacial Biology at UCSF. The SRA's key responsibilities will be to provide assistance for the smooth running of the lab. The main responsibilities are: mouse col ...

  • University of California San Francisco

    Staff Research Associate

    3 weeks ago

    University of California San Francisco San Francisco, United States

    For roles covered by a bargaining unit agreement, there will be specific rules about where a new hire would be placed on the range. · **Department Description** · - The Pulmonary, Critical Care, Allergy and Sleep Medicine Program includes the UCSF Pulmonary, Critical Care, Allerg ...

  • University of California San Francisco

    Staff Research Associate

    3 weeks ago

    University of California San Francisco San Francisco, United States

    For roles covered by a bargaining unit agreement, there will be specific rules about where a new hire would be placed on the range. · **Department Description** · - The Pulmonary, Critical Care, Allergy and Sleep Medicine Program includes the UCSF Pulmonary, Critical Care, Allerg ...

  • University of California San Francisco

    Staff Research Associate

    6 days ago

    University of California San Francisco San Francisco, United States

    The Staff Research Associate (SRA) position will be involved in research with Dr. Robert Warren, the principal investigator of the Surgical Oncology Research Lab. The SRA will conduct research related to growth of organoids as models to study targeted therapeutics against cancers ...

  • Compugen USA

    Research Associate/associate Scientist

    1 day ago

    Compugen USA San Francisco, United States

    Compugen's extraordinary multidisciplinary team is one of its greatest assets. Our employees, coming from different backgrounds with diverse ways of thinking, work together in an atmosphere that cultivates excellence, creativity and openness. The cooperation of people from variou ...

  • University of California San Francisco

    Staff Research Associate

    6 days ago

    University of California San Francisco San Francisco, United States

    The Savic lab seeks an entry-level Staff Research Associate I (SRA I) to support a laboratory that is engaged in groundbreaking drug development projects for infectious diseases including tuberculosis, HIV, and malaria, as well as pain management and autoimmune disease with a foc ...

  • University of California San Francisco

    Staff Research Associate I

    2 weeks ago

    University of California San Francisco San Francisco, United States

    The Brain Tumor Center at UCSF focuses on developing new treatments for patients with malignancies of the central nervous system by · - (1) studying the mechanisms through which brain tumors develop and become resistant to treatments and · - (2) identifying novel therapeutic targ ...

  • Rezo Therapeutics

    Research Associate, Compound Managment

    1 week ago

    Rezo Therapeutics San Francisco, United States

    **The Opportunity** · We are seeking a highly enthusiastic and motivated Research Associate, Compound Management to join our Operations team. This part-time role will be responsible for receiving and processing compound samples from internal and external sources, managing and ful ...

  • Northern California Institute for Research and Education

    Staff001423 Staff Research Associate I

    2 weeks ago

    Northern California Institute for Research and Education San Francisco, United States

    Northern California Institute for Research and Education (NCIRE) is the leading nonprofit research institute in the United States devoted to advancing Veterans health research. NCIRE is part of one of the world's most dedicated and successful Veterans care communities, pioneering ...

  • Gladstone Institutes

    Research Associate I- Huang Lab

    1 week ago

    Gladstone Institutes San Francisco, United States

    Category: · Science · Lab/Area: · Huang Lab · Description: · Who we are: · The Gladstone Institutes is an independent, not-for-profit research institution. Its mission is to improve the health and well-being of all people through medical research and education in neuroscience, ca ...

  • University of California San Francisco

    Staff Research Associate I

    1 week ago

    University of California San Francisco San Francisco, United States

    This is a laboratory-based research position focusing on pathways that link metabolism to neural mechanisms that regulate feeding behavior and learning and memory. We are specifically interested in the role of steroid hormones in this process. In this research, we heavily utilize ...

  • Northern California Institute for Research and Education

    Staff001449 Staff Research Associate Ii

    6 days ago

    Northern California Institute for Research and Education San Francisco, United States

    Northern California Institute for Research and Education (NCIRE) is the leading nonprofit research institute in the United States devoted to advancing Veterans health research. NCIRE is part of one of the world's most dedicated and successful Veterans care communities, pioneering ...

  • Mammoth Biosciences

    Research Associate Ii

    2 weeks ago

    Mammoth Biosciences Brisbane, United States

    OPPORTUNITY · **KEY RESPONSIBILITIES**: · - Evaluate and implement purification technology and optimized existing techniques and workflows · - Assume responsibility for critical reagent sourcing and maintain adequate supply and inventory · - Plan, execute and carefully document e ...

  • Vilya, Inc.

    Research Associate

    1 week ago

    Vilya, Inc. South San Francisco, United States

    Vilya is a computational biotechnology company creating a novel class of medicines to precisely target disease biology. We believe computational approaches are an integral, if not foundational, component of drug discovery and development. Our platform is built on ground-breaking ...

  • Fladger Associates

    Research Associate

    1 week ago

    Fladger Associates Foster City, United States

    Responsibilities: · - Excellent employment opportunity for a Research Associate - Biology in the Foster City, CA area. (Onsite) · - We are seeking a highly motivated in vivo Research Associate to join our Inflammation group. · - The in vivo activities will include dosing (PO, SC, ...

  • Charles River Laboratories

    Research Associate Ii

    2 weeks ago

    Charles River Laboratories South San Francisco, United States

    **Req ID #**:222512**Location**:South San Francisco, CA, US, For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health a ...

  • R&D Partners

    Research Associate

    3 weeks ago

    R&D Partners San Francisco, United States

    R&D Partners is seeking to hire a Research Associate III in South San Francisco, CA. Your main responsibilities as a Research Associate III: This laboratory-based role involves performing, qualifying and implementing biological assays and technologie Research Associate, Associate ...

  • Fladger Associates

    Research Associate

    3 weeks ago

    Fladger Associates Foster City, United States

    Responsibilities: · - Excellent employment opportunity for a Research Associate - Protein Therapeutics in the Foster City, CA area. (onsite) · - Seeking a highly motivated Research Associate to join our protein purification and QC group within the Protein Therapeutics Department. ...

  • R&D Partners

    Research Associate

    2 weeks ago

    R&D Partners San Francisco, United States

    R&D Partners is seeking to hire a Research Associate I in South San Francisco, CA. Your main responsibilities as a Research Associate I: Recording scientific observations during gross examinations Excising, weighing, and fixating tissues during necro Research Associate, Associate ...