Senior Clinical Research Associate
About The Position
This is a field-based and remote opportunity in an assigned U.S. geography. The Senior Clinical Research Associate (internal title: Sr CRA) manages trusted site relationships and performs on-site and remote monitoring activities to support the initiation, conduct, and timely completion of Phase I–IV clinical trials. The role ensures compliance with ICH/GCP, local regulations, Novartis Standard Operating Procedures, and monitoring procedures. As a key contact for investigational sites, the Senior CRA proactively manages site performance, recruitment, quality, risks, and issue resolution to support sustainable trial execution and high-quality data delivery. The role may involve complex trials and/or less experienced sites, and may include serving as a subject matter expert, supporting audit and inspection readiness, ensuring timely corrective actions, and collaborating with local and global cross-functional teams to improve processes. The role can be based remotely anywhere in the U.S., subject to possible legal-entity restrictions, and does not include relocation support. Candidates should be located near an airport; Houston, Dallas, Oklahoma, New Mexico, Arkansas, Kansas, Missouri, Iowa, and Nebraska are listed as highly desirable locations. Travel by plane or car may reach 80% of the time. Working hours and domestic and/or international travel expectations will be defined by the hiring manager.
Requirements
- At least 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.
- Fluency in written and spoken English.
- Fully valid and unrestricted driver's license; driving and air travel are essential functions of the role.
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.
- Perform continuous on-site and remote monitoring to support 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 drive 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 activities and ensure timely implementation of corrective actions.
Benefits
- Performance-based cash incentive.
- Eligibility to be considered for annual equity awards, depending on role level.
- Health benefits.
- Life benefits.
- Disability benefits.
- 401(k) with company contribution and match.
- Vacation, personal days, holidays, and other leaves.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
