Clinical Research Associate

12 month renewable contract

1099 ONLY

paid hourly, door to door

MUST BE LOCATED IN MIAMI, FL (or nearby)

Job Title:

Clinical Research Associate

Job Description

This Clinical Research Associate (CRA) role focuses on onsite monitoring of complex, high‑volume clinical trials in patients with end‑stage kidney disease and related cardiovascular outcomes. The position requires candidates to be based in South Florida, with a strong preference for those located in the Miami metropolitan area, and involves frequent travel primarily throughout Florida with the flexibility to support sites nationwide.

The CRA will be dedicated to a single, large multi‑center study and will balance intensive onsite monitoring with robust remote site management and in‑house clinical operations support. The role offers the opportunity to contribute to high‑impact research that advances patient care while working within a collaborative, mission‑driven environment.

Responsibilities

+ Conduct full‑scope onsite monitoring visits for a multi‑center coordinated clinical trial, including site initiation, routine monitoring, and close‑out activities.

+ Perform source data verification and review electronic case report forms (eCRFs) to ensure data accuracy, completeness, and consistency with protocol requirements.

+ Monitor compliance with Good Clinical Practice (GCP), study protocols, and applicable regulatory requirements at assigned sites.

+ Oversee a high volume of study sites, managing a heavy workload and ensuring timely completion of monitoring activities across more than 200 sites as the study expands.

+ Support study start‑up and site activation by collecting, reviewing, and facilitating approval of essential regulatory documents from participating sites.

+ Maintain ongoing communication with site staff to address questions, resolve issues, and promote protocol adherence and data quality.

+ Collaborate with the Clinical Trial Coordinator (CTC) to oversee and maintain the electronic Trial Master File (eTMF), ensuring timely and accurate document filing.

+ Update and maintain the Clinical Trial Management System (CTMS), including trip reports, monitoring metrics, and site status information.

+ Monitor key cardiovascular outcome endpoints such as major adverse cardiovascular events (MACE), heart failure, hospitalization, stroke, myocardial infarction, and mortality, ensuring accurate reporting and documentation.

+ Identify, document, and follow up on protocol deviations, data discrepancies, and other issues, working with sites to implement corrective and preventive actions.

+ Balance field‑based monitoring with remote site management and operational support during periods of fluctuating monitoring demand.

+ Adapt to changing priorities and timelines, managing multiple assignments and travel schedules while meeting study deadlines.

+ Work independently with minimal supervision, proactively planning visits, prioritizing tasks, and escalating issues when necessary.

+ Contribute to a collaborative, transparent, and inclusive team culture by sharing best practices and supporting colleagues across clinical operations.

Essential Skills

+ Minimum of 7+ years of recent (within the past year) experience as a Clinical Research Associate with full‑scope responsibilities from site setup through monitoring and close‑out.

+ Demonstrated experience in site management and onsite monitoring for multi‑center coordinated studies.

+ Proven ability to manage a high volume of sites and a heavy monitoring workload, including experience with large‑scale trials involving over 200 sites.

+ Recent (within the past 2 years) CRA monitoring experience in nephrology, renal, dialysis, chronic kidney disease (CKD), or end‑stage renal disease (ESRD) clinical trials.

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Experience with cardiovascular outcome studies, including endpoints such as MACE, heart failure, hospitalization, stroke, myocardial infarction, or mortality.

+ Strong knowledge of Good Clinical Practice (GCP) and regulatory requirements applicable to clinical trials.

+ Hands‑on experience with electronic case report forms (eCRFs) and systems such as Rave or similar EDC platforms.

+ Proficiency using Clinical Trial…