Background

Before new medical treatments can be administered to the public, they must demonstrate safety and efficacy in a clinical trial. These trials protect consumers from ineffective and dangerous products, but the clinical trial process also presents a tremendous bottleneck in delivering life-saving treatments to patients.

A typical trial involves coordinating between numerous parties and data formats to gather, store, analyse, and audit clinical data. Mistakes and delays are common, and fewer than 10% of trials finish on time. At TrialSpark, we are reimagining the clinical trial process from first principles, and building the technology platform for the trial of the future.

So far, we’ve worked with treatments for Ebola, Depression, and HIV. Our reach is growing rapidly, and building a world class engineering team is core to achieving our mission.

Position Overview

The Research Assistant (RA) is responsible for supporting the regional clinical team, including Clinical Research Coordinators (CRCs), Senior CRCs and Clinical Research Nurses (CRNs), in conducting clinical trials across the TrialSpark site network in partnership with Principal Investigators (PIs). The RA is expected to operate in accordance with TrialSpark’s Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) guidelines and applicable federal and state regulations, including those stipulated by the U.S. Food and Drug Administration (FDA) and the Health Insurance Portability and Accountability Act (HIPAA). In addition, the RA is expected to support initiatives to improve TrialSpark’s clinical processes and the broader organization.

Duties and Responsibilities

Duties include, but are not limited to: 

• Reviewing and attaining fluency in study protocols, developing an understanding of the study background, design, purpose, investigational product, schedule of events, risks / benefits, inclusion / exclusion criteria and objectives / primary endpoints
• Identifying study-eligible trial sites through network physician Electronic Health Record (EHR) review
• Identifying study-eligible patients through trial site Electronic Health Records (EHR) review in collaboration with PIs
• Coordinating the scheduling and logistics of patient screening, baseline, treatment, follow-up and other study-related visits
• Collecting, transporting, processing and shipping biological samples in accordance with study protocol
• Provides support as needed with regulatory binder maintenance throughout the trial
• Handling and storing study data in compliance with study protocol and IRB requirements
• Transcribing source data into Electronic Data Capture (EDC) and clarifying and resolving data queries in accordance with Service Level Agreements (SLAs)
• Assisting with setting up trial sites at the start of clinical trials and with closing out trial sites at the end of clinical trials, and maintaining trial sites in an inspection and/or audit ready state in at all times
• Responding to requests for information and access from inspectors and/or auditors
• Contributing to the mapping and building of study-specific eSource
• Supporting the development of new processes, procedures, tools and training to enhance clinical research activities across TrialSpark
• Supporting cross-functional teams working on initiatives to improve the broader organization

Experience and Qualifications

• Bachelor’s degree required; Life Sciences, Statistics, Mathematics majors, and MPH applicants are encouraged to apply
• 2+ years experience in clinical research preferred

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.