Clinical Quality Associate I

hace 5 días

Ciudad de México Curebase A tiempo completo

**About the role**:
Curebase is seeking a Clinical Quality Associate I who will thrive in a quickly scaling healthcare technology environment. Quality at Curebase is deeply cross-functional, and you will work with nearly every function at the company to conduct risk-based quality management (RBQM) surveillance of Clinical Operations activities at Curebase. This role places an emphasis on risks impacting patients' safety and data quality to ensure compliance with internal SOPs and applicable regulations (e.g., ICH-GCP, US CFR related to clinical quality). This role reports directly to the Director of Clinical Quality.

**What you'll do**:

- Conduct remote quality reviews of clinical trial data and documentation (e.g., essential documents [i.e., eTMF, eISF], clinical database, training records)
- Document non-compliances (e.g., regulatory, protocol, SOP) and clinical quality issues, ensuring appropriate actions (e.g., quality events, CAPAs)
- Ensure trials are inspection ready at all times in partnership with Clinical Operations
- Participate in activities related to client audits and regulatory inspections
- Participate in the evaluation of external partners (e.g., clinical sites, vendors), including conducting audits (remote or in-person) on an as needed basis
- Contribute to the maintenance of controlled documents related to clinical quality assurance within the Quality Management System
- Assist in tracking of clinical quality compliance metrics to identify risks and trends across clinical trials
- Partner with Clinical Operations in the development of study-level plans related to clinical quality (e.g., Clinical Monitoring Plan)
- Implement and perform study-specific internal clinical quality audit plans as applicable
- Participate in the review and approval of electronic builds for clinical trial protocols
- Contribute to the review of clinical trial documents (e.g., protocol, consent) for quality and regulatory compliance on an as needed basis
- Participate in the implementation of clinical quality improvement initiatives

**About you**:

- Bachelor's degree in life sciences or related field
- Minimum of three (3) years' experience in clinical research, preferably in clinical quality or clinical operations (e.g., Clinical Quality Associate, Clinical Research Coordinator, Regulatory Coordinator)
- Well-versed in relevant ICH-GCP, US CFR, and HIPAA regulations
- Proven ability to work well with a remote-based team
- Clear demonstration of organizational and communication skills
- Ability to excel in a fast-paced and rapidly changing environment
- Demonstrates and recognizes the importance of adaptability and eagerness to learn and adapt to technology changes over time
- Willingness to travel for job-related activities if required (expected travel for this position is < 10%)

**Major pluses**:

- Previous experience working at a startup
- Previous experience working with global teams

**About Curebase**:
Curebase is reinventing decentralized clinical trials to help the vast majority of potential patients that currently cannot access clinical research. Our vision is that any patient, no matter where they are located, should be able to participate in clinical trials at home and with their own doctors. This is made possible through a unique suite of tools Curebase's has designed to engage patients in clinical trials across all settings, be it at home, at their local clinic, or other places in their community.

This starts with Curebase's leading decentralized clinical trial software platform that is an all-in-one, purpose built eClinical software system, with every tool needed to manage and collect data for decentralized clinical trials. This includes ePRO, eCOA, eConsent, Telemedicine, and much more. Curebase also offers a virtual research site, complete with virtual investigators, research coordinators, mobile nursing, and other healthcare staff that administer care to patients where convenient for them, just like any other research site, but with the ability to stand up anywhere and with greater patient convenience and reach. Notably, Curebase is the pioneer of the "BYOP" or Bring Your Own Physician model, allowing patients to use their own doctors to participate in clinical trials.

We are reinventing a $45B market, enabling drug and device companies to increase the volume, quality, and speed of data collection regardless of patients' physical location. COVID-19 tailwinds have created massive demand for telemedicine and home-based trials, with two new FDA guidance letters and industry-wide adoption of remote remote research that will only accelerate in the years to come. You can learn more about Curebase and our next stage of growth in Crunchbase, Fierce Biotech, and MedCity News

**Benefits**:

- Passionate team dedicated to making a positive impact
- Unlimited career growth opportunity
- Virtual social and team building events

**Not sure you qualify?**:
Curebase provides equal employment opportuniti

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