Clinical Research Associate

About the role

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.

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.
• Prompted 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.
• 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 Management Systems (CTMS) for trip reports, monitoring metrics, and site tracking.
• Excellent organizational skills and attention to detail, with the ability to manage complex documentation and multiple priorities.
• Ability and willingness to travel up to 85% for onsite monitoring and site support.
• Residence in Miami, Florida or the broader South Florida area, with the ability to support frequent regional travel.
• Ability to work independently with minimal supervision, demonstrating initiative and sound judgment.
• Capability to start within approximately two weeks of an offer, with no upcoming extended absences that would impact workload demands.

Additional Skills & Qualifications

• Proactive, organized, and self-starter mindset with a strong sense of ownership over assigned sites and tasks.
• Comfort working autonomously in a fast-paced, high-volume clinical trial environment.
• Experience collaborating with cross-functional clinical operations teams, including Clinical Trial Coordinators and other CRAs.
• Strong written and verbal communication skills to interact effectively with site personnel and internal stakeholders.
• Ability to adapt to fluctuating monitoring demands, shifting between intensive onsite visits and periods focused on remote site management.
• Interest in contributing to clinical research that advances care for patients with kidney disease and cardiovascular conditions.
• Openness to professional development through training programs, mentorship, and exposure to diverse therapeutic areas.
• Reliability in meeting deadlines and maintaining high quality standards under competing priorities.

Work Environment

This role operates within a 100% remote work environment for administrative, documentation, and coordination tasks, combined with frequent onsite visits to clinical trial sites. Candidates will work primarily from their home office when not traveling, using electronic systems such as eCRFs, Rave, CTMS, and eTMF platforms to manage study activities. Travel may reach up to approximately 85%, with a focus on sites throughout Florida and additional trips to sites across the United States as needed. The position supports a large, complex, multi-center study, so workloads can be intensive, with periods of multiple onsite visits in a week followed by intervals of remote site management and operational support. The culture emphasizes meaningful work, collaborative teamwork, transparency, and shared success, offering opportunities for professional growth, training, mentorship, and exposure to a broad range of therapeutic areas. Work arrangements may include hybrid flexibility when not traveling, supporting work-life balance while maintaining high standards of clinical research quality and compliance.

Work Arrangements

Dress expectations align with professional attire appropriate for clinical and research site visits.

Job Type & Location

This is a Contract position based out of Miami, FL.

Pay And Benefits

The pay range for this position is $85.00 - $90.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.