Sr. Clinical Research Associate

Clinical Research Associate

+ Duration: 12 month renewable
- Long term

+ Location of CRA: located in East.

+ travel:
National

+ Therapeutic area:
Cardiology and Liver disease trials. Must have recent experience of both

+ Must live near Major Airport

Job Description

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…