Regulatory Associate at TrialSpark
TrialSpark is a technology company that brings new medical treatments to patients faster by reimagining the clinical trial process. Today, a clinical trial can cost more than $100M and take 10 years to complete, bottlenecking the development of new treatments for patients.
Our company is using software and technology to streamline all aspects of a clinical trial. By reducing the time and cost it takes to run a clinical trial, we empower more treatments to be ultimately brought to patients.
TrialSpark’s business lines:
In short, TrialSpark works with our Biotech and Pharma partners in 3 ways: 1) we provide standalone digital advertising-based patient recruitment services, 2) we operate trial sites in support of phase II-IV clinical trials, and 3) we run end-to-end Phase II studies as an alternative to a Contract Research Organization (CRO).
The Clinical Research Regulatory Associate will manage regulatory activity for clinical research trials TrialSpark is engaged on. They will oversee ensuring our studies meet regulatory requirements at the federal and state level, including supporting study and site startup, reporting, and closeout submissions to Institutional Review Boards (IRB) and relevant regulatory agencies and sponsors.
Given the importance of sound regulatory execution in ensuring patient safety, quality, and compliance, this team member must have impeccable judgement, a strong work ethic, and high ethical standards.
- Maintain a working understanding of Food and Drug Administration (FDA), International Conference on Harmonization (ICH), Code of Federal Regulations (CFR), and Good Clinical Practice (GCP) policies and guidelines as they relate to the conduct of human clinical trials.
- Understanding of the research protocols and the ability to translate research requirements into appropriate regulatory actions.
- Preparation and maintenance of all regulatory matters, including site-level essential documents (ICFs, CVs, licenses, etc.), IRB submissions, and governmental regulatory documents (e.g., FDA 1572s).
- Partner closely with Clinical Operations, QA, and other functions to weave regulatory excellence into our organization.
- Support of study and site start-up regulatory activities, ongoing IRB continuing reviews, modifications, and study closeout regulatory documents.
- Supporting Training team in education for Clinical Research staff on regulatory standards.
- Managing archiving of clinical trial documents and records, in accordance with government and sponsor standards.
- Responsible for overall management of electronic Investigator Site File (eISF) solution, including overseeing KPIs on completeness and timeliness of key regulatory documents.
- Preparation for internal and external inspections, audits and monitoring visits, including partnering with the QA team and clinical research coordinators to prepare regulatory binders and documents.
- Bachelor’s degree (B.S. preferred)
- Minimum of 3 years experience in clinical research space, as a regulatory specialist, eTMF administrator, CRC, CRA, or related role; prior regulatory-focused experience preferred.
- Hard-working self-starter that can thrive in an ambiguous environment.
- Preferred experience managing regulatory across a multi-site environment, including experience with digital ISF / CTMS / eTMF solutions.
- An earnest desire to improve the way clinical trials are run and bring new treatments to patients in need.
You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.