Clinical Research Associate

1 month ago

Redwood City, United States Galvanize Therapeutics, Inc. Full time

Galvanize is a biomedical platform company operating at the convergence of engineering, biology, and healthcare delivery, aiming to deliver life-changing solutions to patients and their doctors. We design and develop Pulsed Electric Field Systems to achieve meaningful and lasting therapeutic outcomes for patients.


General Description


The Clinical Research Associate (CRA) will ensure clinical studies are executed at the clinical site level to the highest level of quality and compliance in accordance with internal standard operating procedures (SOP)s, the study protocol, relevant study plans, and applicable local and national regulations. This role will also be responsible for ensuring clinical trials are adequately monitored such that subjects’ rights, safety, and welfare are protected and that the clinical trial data are reliable.


The CRA has the experience to interact competently with investigational sites. This role works with personnel at clinical investigational sites on routine and complex matters to accomplish proper study execution during all phases of clinical trials. The position requires business travel.


The CRA will under the general guidance of a Manager.


Key Requirements


Education and Training:

  • Bachelor’s degree in life sciences, medicine, or technical discipline preferred.
  • Advanced degree (MD, PhD, MS, DVM) and 1-2 years clinical research experience, or
  • BS and minimum 3+ years clinical trial experience, or 5+ years clinical trial experience, or
  • Completion of a certification program in clinical trial conduct and 3-5 years clinically focused industry experience. Exceptional experience/background in a particular scientific area that meets a specific business need but with less clinical trial experience.
  • Oncology experience preferred


Skills and Experience:

  • Medical device research experience preferred
  • Experience with clinical monitoring activities
  • Knowledge of US and international clinical regulations and guidelines
  • Proficient in Microsoft Office with technical abilities to become proficient quickly with numerous other electronic systems.
  • Detailed oriented, with solid organization and time management skills. Able to work independently and in a team environment.
  • Complete projects with reliability and minimal guidance
  • Good communication skills with the ability to interact with site personnel to ensure compliance.


Travel: Ability to travel up to 70%, domestically. Overnight travel may be required.


Key Responsibilities

  • Supports all clinical research activities essential to the successful execution of clinical studies
  • Supports assigned site activities through all phases of the clinical trial including site qualification, site initiation, subject enrollment and follow-up, monitoring, and site close-out at assigned sites, ensuring adherence to applicable regulations, principles of ICH-GCP, SOPs, the study protocol, and relevant study manuals
  • Performs on-site and/or remote monitoring visits: Site Initiation (SIV), interim monitoring (IMV), and close-out (COV) per the requirements of the study specific monitoring plan, the protocol, and internal SOPs
  • Coordinates, schedules, and conducts monitoring visits at investigational sites to ensure compliance to the clinical protocol, Federal, State, and local regulations, the principles of ICH/GCP and internal standard operating procedures
  • Performs source data verification of clinical data entered into Electronic Data Capture (EDC) system or paper CRFs to ensure regulatory and protocol compliance and overall accuracy of the study data
  • Facilitates and tracks site IRB/EC submission, approval, annual review, and closure process at assigned sites
  • Ensures proper documentation of site personnel training and delegation of authority.
  • Establishes and maintains regular contact with investigational site personnel to ensure ongoing protocol compliance, resolution of action items and queries, and accurate and timely data entry
  • Identifies, documents, and communicates quality and/or compliance related issues in a timely manner to a senior team member
  • Ensures that study documentation is up to date and audit ready at sites and within the study trial master file (TMF) through periodic TMF QC checks.
  • Participates in protocol training for investigators, study coordinators and other site personnel.
  • Contributes to the development of study materials and review of eCRFs, EDC systems and source worksheet creation
  • Contributes to the development of clinical documents such as clinical protocols, consent forms, clinical monitoring plans, clinical study reports, annual regulatory reports, and clinical reports/forms/SOPs/Work Instructions.
  • Tracks and provides updates to study management on potential trends noted across multiple sites and discusses potential strategies to remedy any potential issues
  • Escalates observed deficiencies and issues to clinical study management and follows issues through to resolution
  • Responsible for tracking and reconciliation of investigational product inventory at assigned sites and study-wide; follows-up with investigational sites
  • Professionally represents the company
  • Develops and maintains cross functional and collaborative relationships within the company and at investigational sites
  • Assists clinical study manager with other duties as needed


What Galvanize Offers


  • Medical, Dental, Vision, Life Insurance, LTD/STD
  • 100% company paid medical coverage for employees
  • Flexible Paid Time Off
  • Paid Parental Leave
  • Company sponsored 401(k)


This role pays between $115,000 and $125,000 per year, and your actual base pay will depend on your skills, qualifications, experience, and location.


Due to the nature of our business and the role, please note that Galvanize Therapeutics may require that you show current proof of vaccination against certain diseases including COVID-19.


Galvanize Therapeutics is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.


We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

  • Senior Clinical Research Associate

    2 months ago

    Kansas City, United States Everest Clinical Research Services Inc Full time

    Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical...

  • Lead Clinical Researcher

    10 hours ago

    Jersey City, New Jersey, United States DM Clinical Research Full time

    Job OverviewLead Clinical Researcher (MD/DO)The Lead Clinical Researcher will oversee all clinical trials in alignment with ICH, GCP, local regulations, study protocols, and organizational procedures.Key ResponsibilitiesGuarantees the medical safety and well-being of study participants through the diligent execution of clinical trials.Supports the...

  • Lead Clinical Researcher

    6 hours ago

    Jersey City, New Jersey, United States DM Clinical Research Full time

    Job OverviewLead Clinical Researcher (MD/DO)The Lead Clinical Researcher will oversee all clinical trials in accordance with ICH, GCP, local regulations, study protocols, and organizational procedures.Key ResponsibilitiesGuarantees the medical welfare and safety of participants through the careful execution and management of studies.Assists in ensuring...

  • Clinical Research Coordinator II

    2 months ago

    Jersey City, United States DM Clinical Research Full time

    Job DescriptionJob DescriptionClinic Research Coordinator II The Clinical Research Coordinator II, will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC I will also ensure study...

  • Clinical Research Coordinator III

    2 months ago

    Jersey City, United States DM Clinical Research Full time

    Job DescriptionJob DescriptionClinical Research Coordinator IIIA CRC III will ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. To ensure study enrollment meets or exceeds Sponsors' expectations. To...

  • Clinical Research Coordinator III

    2 days ago

    Jersey City, United States DM Clinical Research Full time

    Job DescriptionJob DescriptionClinical Research Coordinator IIIA CRC III will ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. To ensure study enrollment meets or exceeds Sponsors' expectations. To...

  • Clinical Research Associate

    1 month ago

    Redwood City, United States Galvanize Therapeutics, Inc. Full time

    Galvanize is a biomedical platform company operating at the convergence of engineering, biology, and healthcare delivery, aiming to deliver life-changing solutions to patients and their doctors. We design and develop Pulsed Electric Field Systems to achieve meaningful and lasting therapeutic outcomes for patients.General DescriptionThe Clinical Research...

  • Unblinded Clinical Research Coordinator I

    1 month ago

    Jersey City, United States DM Clinical Research Full time

    Job DescriptionJob DescriptionUnblinded Clinical Research Coordinator IDM Clinical Research is looking to hire an Unblinded Clinical Research Coordinator to join our team. This individual will be responsible for dispensing Investigational Products (IP) as part of clinical research trials.Duties & Responsibilities:Compound and dispense prescribed IP.    ...

  • Lead Clinical Research Specialist

    5 days ago

    Kansas City, Missouri, United States Everest Clinical Research Services Inc Full time

    Company Overview: Everest Clinical Research Services Inc. is a premier contract research organization (CRO) delivering a comprehensive suite of expertise-driven clinical research solutions to global pharmaceutical, biotechnology, and medical device sectors. We collaborate with some of the most recognized companies and engage with numerous advanced...

  • Lead Clinical Research Specialist

    5 days ago

    Kansas City, Missouri, United States Everest Clinical Research Services Inc Full time

    Company Overview: Everest Clinical Research Services Inc. is a premier contract research organization (CRO) dedicated to delivering a comprehensive suite of expertise-driven clinical research solutions to global pharmaceutical, biotechnology, and medical device sectors. We collaborate with some of the most renowned companies and are involved with many of...

  • Lead Clinical Research Specialist

    13 hours ago

    Kansas City, Missouri, United States Everest Clinical Research Services Inc Full time

    Company Overview: Everest Clinical Research Services Inc. is a comprehensive contract research organization (CRO) offering a wide array of expertise-driven clinical research solutions to global pharmaceutical, biotechnology, and medical device sectors. We collaborate with some of the most reputable companies and engage with many of the most innovative...

  • Lead Clinical Research Investigator

    6 hours ago

    Jersey City, New Jersey, United States DM Clinical Research Full time

    Job OverviewPosition: Principal Investigator (MD/DO)The Principal Investigator will oversee all clinical trials in accordance with ICH, GCP, local regulations, study protocols, and organizational procedures.Key ResponsibilitiesSafeguards the medical well-being and safety of study participants through the diligent execution of clinical trials.Maintains...

  • Senior Clinical Research Associate

    4 weeks ago

    Redwood City, United States Rezolute, Inc. Full time

    OverviewThe Clinical Research Associate II (CRA) will work closely with the Clinical Operations team to support the full scope of study activities, including site activation, patient recruitment, study monitoring, site and vendor management. The CRA II will work cross functionally within the Rezolute team as well as with study sites, CROs and other...

  • Senior Clinical Research Associate

    4 weeks ago

    Redwood City, United States Rezolute, Inc. Full time

    OverviewThe Clinical Research Associate II (CRA) will work closely with the Clinical Operations team to support the full scope of study activities, including site activation, patient recruitment, study monitoring, site and vendor management. The CRA II will work cross functionally within the Rezolute team as well as with study sites, CROs and other...

  • Senior Clinical Research Associate

    1 day ago

    redwood city, United States Rezolute, Inc. Full time

    OverviewThe Clinical Research Associate II (CRA) will work closely with the Clinical Operations team to support the full scope of study activities, including site activation, patient recruitment, study monitoring, site and vendor management. The CRA II will work cross functionally within the Rezolute team as well as with study sites, CROs and other...

  • PRN part-time Clinical Research Nurse

    4 weeks ago

    Salt Lake City, United States Icon Clinical Research Full time

    At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives. Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration,...

  • PRN part-time Clinical Research Nurse

    4 weeks ago

    Salt Lake City, United States ICON Clinical Research Full time

    At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives. Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration,...

  • Clinical Research Coordinator

    2 weeks ago

    Kansas City, United States Alcanza Clinical Research Full time

    Job DescriptionJob DescriptionDescriptionAlcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general...

  • Senior Clinical Research Associate

    2 months ago

    New York City, United States Worldwide Clinical Trials - USA 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...

  • Clinical Research Coordinator

    2 weeks ago

    Lake City, United States Wake Research Full time

    Job DescriptionJob DescriptionCompany DescriptionM3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the...