Senior Clinical Research Associate

Novartis
•$108,500 - $201,500•Hybrid

About The Position

Novartis is hiring a Senior Clinical Research Associate (internal title: Sr CRA) for a field-based and remote role in an assigned geography. The role must be based in the western United States near a major airport, preferably in California; relocation support is not available. The position requires 80% travel and involves driving and air travel as essential functions. The Senior CRA manages site relationships and performs on-site and remote monitoring to support the initiation, conduct, and timely completion of Phase I–IV clinical trials in accordance with ICH/GCP, local regulations, SOPs, and monitoring procedures. The role serves as a key site contact, overseeing site performance, recruitment, quality, risk management, and issue resolution to support reliable trial execution and high-quality data. For complex trials and/or less experienced sites, the Senior CRA may serve as a subject matter expert, support audit and inspection readiness, ensure timely corrective actions, and collaborate with local and global cross-functional teams to improve processes. The expected annual salary range is $108,500–$201,500. Compensation includes a performance-based cash incentive and, depending on role level, possible eligibility for annual equity awards. Eligible US-based employees receive health, life, and disability benefits, a 401(k) with company contribution and match, other benefits, and paid time off including vacation, personal days, holidays, and other leaves.

Requirements

  • At least 3 years of experience in site monitoring.
  • BS/BA degree in a scientific, healthcare, or other related field.
  • Excellent knowledge of the drug development process, specifically 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.
  • Ability to meet the role’s essential driving and air-travel requirements; the position requires 80% travel.

Nice To Haves

  • Cardiology experience.
  • Oncology experience.
  • CART experience.
  • RLT experience.
  • Immunology 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 of 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 in support of 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 when applicable.

Benefits

  • Performance-based cash incentive.
  • Potential eligibility for annual equity awards, depending on the level of the role.
  • Health benefits.
  • Life benefits.
  • Disability benefits.
  • 401(k) with company contribution and match.
  • Other employee benefits.
  • Time off including vacation, personal days, holidays, and other leaves.
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