Sr. Clinical Research Associate

Clinical Research Associate

The Clinical Research Associate (CRA) will conduct onsite monitoring visits across the United States and provide comprehensive site management support for complex, high-volume cardiovascular clinical trials. The role combines field-based monitoring with in-house clinical operations, including study start-up, site activation, regulatory document oversight, and maintenance of key trial systems. This position is ideal for an experienced CRA who thrives in a fast-paced, mission-driven research environment and is comfortable managing shifting priorities and substantial workloads.

Responsibilities:

• Conduct onsite monitoring visits at participating study sites across the United States, ensuring compliance with the protocol, Good Clinical Practice (GCP), and applicable regulatory requirements.
• Perform full-scope CRA activities across the study lifecycle, including site selection, site setup, routine monitoring, and close-out visits for multi-center coordinated trials.
• Support study start-up and site activation by collecting, reviewing, and facilitating approval of essential regulatory documents from participating sites.
• Maintain regular, clear communication with site staff to address questions, resolve issues, and ensure alignment with study timelines and expectations.
• Oversee and contribute to electronic Trial Master File (eTMF) activities in collaboration with the Clinical Trial Coordinator (CTC), ensuring accurate and timely documentation.
• Ensure timely and accurate updates within the Clinical Trial Management System (CTMS), reflecting site status, visit schedules, findings, and action items.
• Manage a high volume of sites and monitoring activities, balancing weeks with multiple onsite visits and periods focused on remote site management and study support.
• Monitor data quality and integrity, including review of electronic case report forms (eCRFs) and systems such as Rave, and follow up on data queries and discrepancies.
• Identify potential site performance or compliance issues proactively, escalate concerns as appropriate, and support the implementation of corrective and preventive actions.
• Adapt to changing priorities and study demands, organizing workload effectively to meet deadlines and maintain high standards of quality.
• Collaborate closely with internal clinical operations teams to ensure cohesive execution of the study and alignment with overall project goals.
• Demonstrate strong ownership of assigned sites and tasks, taking initiative to support team objectives and contribute to successful study outcomes.

Essential Skills:

• Minimum of 7+ years of recent (within the past year) experience as a Clinical Research Associate with full-scope responsibilities, including site setup, routine monitoring, and close-out.
• Proven experience in site management and onsite monitoring for multi-center coordinated clinical studies.
• Demonstrated ability to monitor and manage a high volume of study sites effectively.
• Recent (within the past 2 years) monitoring experience in cardiovascular clinical trials.
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements for clinical research.
• Hands-on experience working with electronic case report forms (eCRFs) and clinical data systems such as Rave.
• Ability to travel up to approximately 85% of the time for onsite monitoring and study-related visits.
• Residence on the East Coast within convenient proximity to a major airport, enabling frequent travel.
• Excellent verbal and written communication skills, with the ability to communicate clearly and succinctly with site staff and internal teams.
• Strong organizational skills and attention to detail, with the ability to manage complex workloads and shifting priorities.
• Proactive, self-directed work style, with the ability to anticipate issues and act quickly to address them.
• Comfort working in a fast-paced, high-visibility environment while maintaining quality and professionalism.

Additional Skills & Qualifications:

• Demonstrated ownership mindset, taking responsibility for site performance and deliverables.
• Confident and proactive approach to problem-solving and decision-making.
• Willingness to go the extra mile to support colleagues and contribute to team success.
• Ability to build collaborative relationships with cross-functional teams and site personnel.
• Comfort with both field-based monitoring and remote clinical operations work.
• Interest in contributing to mission-driven, high-impact clinical research that advances patient care.
• Openness to ongoing professional growth through training, mentorship, and exposure to diverse therapeutic areas.

Work Environment:

This role operates in a 100% remote work environment, with extensive travel for onsite monitoring visits across the United States. The position involves frequent use of clinical trial technologies and systems, including electronic case report forms (eCRFs), Rave, eTMF platforms, and Clinical Trial Management Systems (CTMS). Work hours may vary depending on site visit schedules, monitoring demands, and study timelines, requiring flexibility and adaptability. The culture emphasizes collaboration, transparency, inclusion, and shared success, offering meaningful work on innovative clinical trials, access to training and mentorship, and opportunities for hybrid-style flexibility within a contract framework.

Job Type & Location:

This is a Contract position based out of Durham, NC.

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)

Workplace Type:

This is a fully remote position.

Application Deadline:

This position is anticipated to close on Aug 21, 2026.