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 In-house CRA position is a role in clinical affairs requiring experience in the conduct of clinical trials. The CRA works closely with members of Clinical Affairs, Regulatory Affairs, and Quality Assurance, and interacts with clinical investigational sites on during all phases of clinical trials. The position is based in the Redwood City, California office and requires minimal business travel.

The CRA will work under the supervision of a more senior CRA, Manager or Clinical Study Manager.

Key Requirements

Education and Training

• BS in life sciences, medicine, or technical discipline preferred.
• 1-3 years clinical trial experience, or
• 1-5 years clinically focused industry experience
• Completion of a certification program in clinical trial conduct is preferred in combination of last two bullet points.

Skills and Experience

• Medical device research experience preferred.
• Knowledge of Good Clinical Practice (GCP) (Course work or hands-on experience).
• Exposure to or experience with clinical monitoring activities.
• 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:

Travel is not routinely expected, but occasional travel may be required.

Key Responsibilities

• Is given a tasks and assignments related to study site management and other clinical departmental projects and systems.
• Routes and processes clinical documents; may create study logs and other tracking mechanisms.
• Manages the TMF for assigned sites and participates in the QC and filing of study-level documents in TMF.
• Supports field CRAs and FCEs during the site identification and qualification process by collecting qualification information from them and filing.
• Supports field CRAs and FCEs during all site startup and closeout activities for assigned sites, collecting, reviewing, and filing clinical documentation in the TMF.
• Supports field CRAs in their preparation for, and follow-up from, monitoring visits.
• Assists the field CRA with the collection of all essential clinical trial documents as required for timely regulatory submissions, site start-up, study conduct, and closeout activities.
• Assists with organizing IRB/EC submissions and applicable regulatory documentation.
• May assist in development of study materials, case report forms (CRFs), informed consent documents for clinical studies.
• May support site start-up/activation process, which may include contributing to the preparation of study related documents (protocols, case report forms/eCRFs, informed consent forms, clinical trial agreements and study budgets, clinical monitoring plan), organizing IRB/EC submissions and applicable regulatory documentation.
• May support TMF and CTMS set-up, maintenance, ongoing quality review, accuracy, and final reconciliation of study documents/payments.
• Interacts with clinical study sites on routine matters to ensure study documentation is up to date at sites.
• Routes CTAs for approval if needed, sets up budget and payment information in CTMS for assigned sites, and generates payments to assigned sites based on CTA and patient recruitment progress.
• Assists in the organization and preparation for Investigator Meetings.
• Assist with tracking and reconciliation of investigational product inventory at assigned sites and study-wide; follows-up with investigational sites and field CRAs/FCE to collect inventory records.
• Responsible for preparing, shipping, and tracking all study supplies and materials.
• Responsible for a variety of clinical administrative tasks such as assembly of study binders, ordering and organizing study supplies, asset tracking, etc.

This role pays between $100,000 and $120,000 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.

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