TrialSpark (51-200 Employees, 12% 2 Yr Employee Growth Rate)

17% 1-Year Employee Growth Rate | 12% 2-Year Employee Growth Rate | LinkedIn | $156M Venture Funding

What Is Employee Growth Rate & Why Is It Important?

About TrialSpark

TrialSpark is a technology-driven drug development company that runs end-to-end clinical trials, focused on bringing new treatments to patients faster and more efficiently.

The biggest bottleneck in bringing new treatments to patients is the clinical trial. On average, getting a drug through the trial process takes nearly a decade and frequently costs $1B+. To combat this industry problem, TrialSpark is building a technology platform that optimizes all aspects of a clinical trial, enabling more efficient trial design, faster trial completion, and higher trial data quality.

TrialSpark recently raised their Series C, and is putting the capital to work by in-licensing and co-developing drug programs through in-house development, joint ventures, and NewCos. Together with doctors, patients, and communities, TrialSpark is working to develop the treatments of tomorrow.

About the Position

The Clinical Research Regulatory Associate will manage regulatory activity for clinical research trials TrialSpark is engaged in. They will work with thePrincipal Investigators (PIs) and their site teams to ensure the sites meet federal and state regulatory requirements ensure our studies meet, including supporting study and site startup, reporting, and closeout submissions to Institutional Review Boards (IRB) and relevant regulatory agencies and sponsors. The Regulatory Associate will ensure the essential documents for a site are complete,compliant, and accurate and that the essential documents are appropriately tracked and filed in the TS eTMF at start-up and throughout the study.

Given the importance of sound regulatory execution in ensuring patient safety, quality, and compliance, this team member must have impeccable judgment, high attention to detail, a strong work ethic, and high ethical standards.

About the Role

  • 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 (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 per government and sponsor standards.
  • Preparation for internal and external inspections, audits and monitoring visits, including partnering with the QA team and clinical research associates.

About You

  • 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.

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.

Tagged as: 51-200 Employees, Hide US-Only Jobs, Venture Funded

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