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 has built 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 Regulatory Associate (RA) will manage regulatory activity for clinical research studies conducted by TrialSpark. They will work with the  sites selected for a clinical trial to ensure the sites meet regulatory requirements at the federal and state level, including documentation supporting study and site startup, reporting, and closeout submissions to central Institutional Review Boards (IRB) and sponsors   The RA will ensure the essential documents for a site are complete,  compliant, and accurate and submitted to the sponsor and/or the TMF in a timely manner in accordance to TS SOPs and study specific study plans. 

Given the importance of sound regulatory execution in ensuring patient safety, quality, and compliance, this team member must understand International Council for Harmonisation Good Clinical Practice (ICH GCP) and the Code Federal Regulations (CFR) related to clinical research, have impeccable judgement,  comprehensive written and verbal communication skills, a strong work ethic, attention to detail, strong personal accountability and organizational skills, and high ethical standards.

Responsibilities

Duties include, but are not limited to: 

• 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
• Understand the central IRBs policies and has the ability to communicate clearly with the IRB for guidance and feedback
• Understand the relationship between the TS SOPs,  TS working instructions and GCPs 
• Collect, review, track and file site-level essential documents (CVs, licenses, financial disclosures, etc.), IRB submissions (protocol, IB, ICF, protocol deviation submissions, SAE reporting, continuing review), and governmental regulatory documents (e.g., FDA 1572s) 
• Communicates with sites on a set cadence during start up
• Provides site start-up updates during internal and external study calls
• Partner closely with Clinical Operations CTM and Site operations for each site’s contract and budget timeline to forecast when each site will have a complete regulatory start up packet
• Support study and site start-up regulatory activities, ongoing IRB continuing reviews, modifications, and study closeout regulatory documents 
• Contributes to the routine TMF completeness checks for the sites essential documents
• Works toward the TS KPIs for the quality of each site’s start up regulatory packet and the TS KPI turnaround time for each site’s regulatory start up packet 
• Assists the TS CTMs and CRAs in preparing for internal and external inspections, audits and monitoring visits 
• Responsible for collecting updated essential documents during study maintenance

Requirements

• Bachelor’s degree preferred
• Minimum of 2 years experience in clinical research in a CRO setting, as a Regulatory Associate, inhouse CRA, CRA, CTM or a role within study-start up group
• Experience managing regulatory submissions across a multi-site environment including experience with IRB portals and eTMF systems
• 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.