Senior Clinical Research Associate (Remote Position)

Novartis Group Companies; United States; Remote; USD 103,000 - 193,000; Full time

Job summary

An established industry player is seeking a Senior Clinical Research Associate to oversee monitoring activities for Phase I-IV clinical trials. This remote role requires a strong background in site management and compliance with international standards. The successful candidate will collaborate closely with clinical project teams and ensure data integrity while traveling up to 80% of the time. This position offers a competitive salary and benefits, making it an exciting opportunity for those passionate about advancing healthcare through clinical research.

Benefits

Comprehensive Benefits

Potential Bonuses

Stock Units

Flexible Working Hours

Qualifications

• 3+ years of site monitoring experience, preferably in oncology.
• Strong knowledge of drug development and clinical trials.

Responsibilities

• Serve as primary site manager for clinical investigative sites.
• Ensure compliance with protocols, GCP, and regulations.

Skills

Site Monitoring

Communication Skills

Problem-Solving

Negotiation Skills

Knowledge of GCP/ICH

Fluency in English

Education

BS/BA Degree in Scientific or Healthcare Discipline

Job description

Job Description Summary

This is a remote-based position. Candidates must be located near an airport in California, Washington, Oregon, Montana, Nevada, Idaho—highly desirable locations. The successful candidate will be required to travel up to 80% of the time. The Senior CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection), and timely completion of Phase I-IV pharma clinical trials within the country.

The Senior CRA is responsible for delivering data within timelines and required quality standards, and for adherence to monitoring procedures in accordance with ICH/GCP, US CFR, and company SOPs.

LI-#Remote

This position can be based remotely anywhere in the U.S. (some restrictions may apply based on legal entity). Please note that this role does not include relocation assistance. Working hours and travel expectations (domestic and/or international) will be defined by the hiring manager. This position will require 80% travel.

Job Description

Your Key Responsibilities:

1. Trial Monitoring Strategy:
2. Serve as the primary site manager for assigned clinical investigative sites, acting as the first point of contact between site staff and Novartis.
3. Allocation, Initiation, and Conduct of Trials:
4. Be the frontline liaison to ensure successful collaboration and milestone achievement.
5. Manage assigned study sites and conduct protocols according to plans and procedures.
6. Facilitate the preparation and collection of site and country-level documents.
7. Perform Site Initiation Visits, train site personnel on trial aspects, and provide ongoing training as needed.
8. Conduct continuous monitoring activities (onsite and/or remote), ensuring compliance with protocols, GCP, and regulations to secure data integrity and patient safety.
9. Update relevant electronic systems regularly.
10. Act as SME (Subject Matter Expert) as needed.

Delivery of Quality Data and Compliance:

1. Monitor studies per current legislations, ICH/GCP, and Novartis standards.
2. Ensure timely, high-quality, reliable data collection.
3. Identify, resolve, and escalate issues appropriately.
4. Collaborate with internal stakeholders and site personnel to manage data queries and ensure accurate data entry.
5. Work proactively with the Clinical Project Manager, CRA Manager, Medical Scientific Liaison, and other partners to meet key objectives.
6. Partner with SSU CRA for seamless site responsibility transition.

Role Requirements:

• BS/BA degree; scientific or healthcare discipline preferred.
• Minimum of 3 years' site monitoring experience, preferably in oncology.
• Experience with CAR T and/or RLT is highly desirable.
• Strong knowledge of drug development, clinical trials, and international standards (GCP/ICH, FDA, EMEA).
• Excellent site management, negotiation, problem-solving, and communication skills.
• Fluent in written and spoken English.

Driving is an Essential Function: A valid, unrestricted driver's license is required. Reasonable accommodations are available for qualified individuals with medical restrictions.

COVID-19 Vaccine Policy: Vaccination may be required based on customer-facing roles and local regulations. Requests for accommodations can be sent to [e-mail].

Compensation and Benefits: The salary range is $103,600 to $192,400 annually, with potential bonuses, stock units, and comprehensive benefits. Final salary depends on various factors including location, experience, and skills.

EEO Statement: Novartis is an Equal Opportunity Employer, committed to diversity and inclusion.

Accommodations: For reasonable accommodations during the application process, contact [e-mail] or call [phone], including the job requisition number.