Senior Clinical Research Associate

Novartis

2d•$108,500 - $201,500•Remote

About The Position

This field-based and remote Senior Clinical Research Associate role supports the initiation, conduct, and timely completion of Phase I–IV clinical trials. The role manages site relationships and performs on-site and remote monitoring to ensure compliance with ICH/GCP, local regulations, Novartis Standard Operating Procedures, and monitoring procedures. The Senior CRA serves as a primary contact for investigational sites and proactively manages site performance, recruitment, quality, risks, and issue resolution to support sustainable trial execution and high-quality data delivery. The position may involve complex trials or less experienced sites and may include serving as a subject matter expert, supporting audit and inspection readiness, ensuring corrective actions are implemented on time, and collaborating with local and global cross-functional teams on process improvements. It is remote within the U.S., subject to possible legal-entity restrictions, and requires travel by plane or car up to 80% of the time. Relocation support is not available; the expectation for working hours and domestic and/or international travel will be defined by the hiring manager.

Requirements

Minimum of 3 years of experience in site monitoring.
BS/BA degree in a scientific, healthcare, or related field.
Excellent knowledge of the drug development process, particularly clinical trials and research.
Knowledge of international standards, including GCP/ICH, FDA, and EMEA.
Ability to manage multiple priorities and time efficiently.
Excellent site management capabilities, with demonstrated negotiating and problem-solving skills.
Strong oral and written communication and presentation skills.
Fluent written and spoken English.
Fully valid and unrestricted driver’s license.

Nice To Haves

RLT, CAR T, or oncology experience.

Responsibilities

Serve as the primary site manager and first point of contact between site staff and Novartis.
Act as a frontline liaison supporting collaboration, milestones, and deliverables.
Monitor in accordance with legislation, ICH/GCP, and Novartis standards.
Manage assigned sites and networks conducting Phase I–IV protocols according to monitoring plans and Novartis procedures.
Conduct site initiation visits and provide ongoing training for site personnel.
Conduct continuous on-site and remote monitoring for protocol, GCP, regulatory, and process compliance, data integrity, and patient safety.
Facilitate preparation and collection of site- and country-level documents.
Identify risks, resolve issues, and escalate concerns as needed.
Collaborate with cross-functional teams to support efficient study execution.
Deliver timely, high-quality, robust, and reliable site data supporting Trial Monitoring goals.
Partner with the SSU CRA to ensure a seamless transition of site responsibility.
Act as a subject matter expert across study activities when required.
Support audit and inspection readiness and ensure timely implementation of corrective actions.