Today, 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 $100M+. And the problem is only getting worse.
At TrialSpark, we don’t believe it has to be this way. Through technology and a new operational model, we’re reimagining how clinical trials are run, with the mission of bringing new treatments to patients faster.
We do this by partnering with physicians to enable them to run clinical trials within their existing practices. By providing the technology platform, equipment, and staffing, TrialSpark alleviates the operational burden of clinical research, enabling physicians to focus on what they do best -- patient care. And by bringing clinical research to physician practices, TrialSpark is enabling access for the 98% of patients who are never exposed to clinical trial opportunities.
As a Clinical Research Coordinator, you will be responsible for the core of what TrialSpark delivers – efficient and high quality clinical trial operations. You will work closely with Principal Investigators (PIs) in the TrialSpark network, Trial Operations colleagues and cross-functional colleagues across the TrialSpark organization to conduct clinical trials across the broader NYC metropolitan area. You also will be expected to seek, identify and execute on opportunities to improve Trial Operations and the broader organization.
Key responsibilities will include:
- Leading study start-up and initiation across TrialSpark trial sites.
- Reviewing and attaining fluency in study protocols.
- Contributing to the development of and executing on strategies to identify and reach patients potentially eligible for relevant studies across TrialSpark trial sites.
- Facilitating the patient informed consent process.
- Conducting patient screening, baseline, treatment, follow-up and other necessary study-related visits.
- Receiving, storing, accounting for and monitoring Investigational Product (IP).
- Maintaining thorough understanding of safety reporting guidelines and monitoring for and reporting Adverse Events (AEs) and Serious Adverse Events.
- Collecting, transporting, processing and shipping biological samples, ensuring all appropriate tests, procedures and laboratory tests are completed.
- Collecting, handling and storing study data, including source documents, Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems.
- Ensuring trial site regulatory binders are maintained throughout the lifecycle of studies
- Clarifying and resolving data queries in source documents and CRFs.
- Proactively communicating with and facilitating collaboration among sponsors, PIs, patients, monitors, IRBs, vendors and other key stakeholders throughout studies.
- Assisting with setting up trial sites at the start of studies and with closing out trial sites at the end of studies, and maintaining trial sites.
- Responding to requests for information and access from inspectors and/or auditors
- Contributing to the mapping and building of study-specific eSource.
- Supporting other CRCs, including conducting quality control checks of their work and providing coaching / feedback to enable professional development.
- Contributing to the development of new processes, procedures, tools and training to enhance clinical research activities across TrialSpark.
- Serving in an advisory capacity for cross-functional teams working on initiatives to improve the broader organization.
Ideal Candidate Profile
- You have at least 1 year of experience as a CRC running industry-sponsored clinical trials.
- You have experience performing phlebotomy, collecting vital signs and performing ECGs.
- You are a certified rater and/or have fluency in EDC systems.
- You have Advanced Cardiac Life Support (ACLS) or Basic Life Support (BLS) certification.
- You have Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA) CRC Certification.
- You possess a deep understanding of site-level quality and Good Clinical Practice Guidelines (GCP) guidelines.
- You are highly process- and detail-oriented.
- You are comfortable operating in a fast-paced environment with a high degree of ambiguity.
- You are proactive, strategic, implementation-focused and ready to roll up your sleeves and make an impact right away.
- You excel in partnering cross-functionally and are known for being someone that people across the company love to work with.
- You are low ego, collaborative, and a fast-learner.
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.