Job Description

Galvanize Therapeutics 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.

The Clinical Research Associate ensures 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. Ensure 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 works under the general guidance of a Manager.

Key Requirements

Education and Training

• Bachelors 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

This role pays between $125,000 and $140,000 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.

Job Tags

Similar Jobs