Job Description

Sr Clinical Research Associate (CRA)/Principal CRA - West job at Thermo Fisher Scientific. San Francisco, CA.

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

This opening targets experienced onsite traveling CRAs with two or more years of CRA experience, specifically monitoring cell or gene therapy, oncology/hematology, rare neurological diseases, ophthalmology, psychiatry, neurodegenerative disorders (including Alzheimers Disease), or kidney and metabolic indications.

At Thermo Fisher Scientific, youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with resources to achieve individual career goals while advancing science through research, development, and delivery of life-changing therapies. Our clinical trials span over 100 countries, supported by our PPD clinical research portfolio, covering laboratory, digital, and decentralized services. Your commitment to quality and accuracy will help improve health outcomes for communities worldwide.

Our global Clinical Operations team within PPD provides end-to-end support for clinical trials, from start-up to close-out, across both commercial and government contracts. We help clients develop clinical programs, minimize delays, and execute high-quality, cost-efficient studies.

Discover Impactful Work

As an experienced CRA, you will perform and coordinate all aspects of clinical monitoring and site management. Responsibilities include conducting remote and on-site visits, assessing protocol and regulatory compliance, and managing documentation. We are hiring for Sr CRA (Level I), Sr CRA (Level II), and Principal CRA roles.

A typical day includes:

• Monitoring investigator sites with a risk-based approach, applying root cause analysis and problem-solving to ensure compliance and reduce risks.
• Ensuring data accuracy through SDR, SDV, and CRF review during monitoring activities.
• Assessing investigational products via physical inventory and records review, documenting observations promptly and professionally.
• Escalating deficiencies and issues to management and following through to resolution.
• Maintaining communication with investigative sites between visits to ensure protocol adherence and issue resolution.
• Conducting monitoring tasks as per the approved plan and participating in investigator payments.
• Collaborating with the project team on issue resolution and participating in investigator meetings.
• Initiating sites according to procedures, ensuring compliance with protocols and regulations, and making recommendations as needed.
• Performing trial close-out and retrieving trial materials.
• Ensuring documentation is complete and compliant with ICH-GCP and regulations.
• Conducting on-site file reviews and providing trial status updates.
• Updating study systems and facilitating communication among stakeholders.
• Responding to audits, inspections, and regulatory requirements.
• Completing administrative tasks timely and contributing to process improvements and project publications.

Keys to Success

Education

• Bachelor's degree in a life science or a Registered Nursing certification, or equivalent.

Experience

• Sr CRA Level I: 2+ years of clinical research monitoring experience.
• Sr CRA Level II: 3+ years of experience.
• Principal CRA: 5+ years with demonstrated high-level expertise in clinical monitoring.

All levels require a valid drivers license where applicable. Equivalent combinations of education, training, and experience may be considered.

Knowledge, Skills, and Abilities

• Proven monitoring skills and understanding of medical/therapeutic areas.
• Knowledge of ICH GCPs, regulations, and procedures.
• Strong analytical, communication, organizational, and interpersonal skills.
• Ability to manage risk-based monitoring and work independently or in teams.
• Proficiency with Microsoft Office and relevant software.

Work Environment

Employees should be able to communicate effectively, work upright and stationary, learn standard office equipment, handle pressure, and travel up to 80% including by automobile, airplane, or train.

Compensation and Benefits

The estimated salary range in California is $82,800$130,000, with potential bonuses and a comprehensive benefits package including health plans, PTO, holidays, parental leave, insurance, retirement plans, and stock purchase options.

This posting covers multiple levels, with salary ranges:

• Level II: $82,800$140,000
• Level III: $104,600$157,000

Thermo Fisher Scientific is an equal opportunity employer and values diversity.

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