Senior Clinical Research Associate

Pharmaceutical Research Associates, Inc • $110K — $138K *
San Diego, CA 92154In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
2 months ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a scientific field preferred
  • Minimum 5 years of independent clinical trial monitoring experience, including at least 2 years in solid tumor trials
  • 1+ year of experience with early development trials
  • Proven track record of site relationship development and compliance management
  • Familiarity with Veeva systems is highly preferred
  • Strong expertise in Good Clinical Practices (GCPs) and oncology-specific monitoring
  • Experience with site activation and training staff

Responsibilities

  • Perform site management activities ensuring inspection readiness and site success
  • Act as primary liaison between the clinical trial team and investigative sites
  • Conduct remote and on-site monitoring visits for data integrity and safety
  • Provide oversight and mentor junior CRAs in monitoring quality
  • Document monitoring activities and manage visit reports effectively
  • Collect essential documents and reconcile files within the Trial Master File
  • Support IRB/Ethics Committee submissions and confirm site approvals
  • Analyze site Key Risk Indicators to identify trends and implement solutions
  • Develop and execute corrective action plans for site issues
  • Deliver training sessions on protocol compliance and regulations
  • Foster relationships with key oncology sites and engage them in the trial process

Benefits

  • Eligible for bonus, stock compensation, and commissions based on performance
  • Opportunities for ongoing professional development and training
  • Flexible working conditions with travel expectations specified
  • Conducive work environment fostering collaboration within the oncology field
Full Job Description
Senior Clinical Research Associate - Oncology - Southern California

The Sr. Clinical Research Associate (Sr. CRA) will be responsible for performing investigative site management and monitoring activities throughout the clinical trial lifecycle. This Sr. CRA role will support the client's Oncology clinical trials to ensure data integrity, subject safety, and inspection readiness at the clinical investigative sites.

Responsibilities:
  • Perform site management activities to support the client's Oncology site success and maintain a continuous state of inspection readiness
  • Act as the primary contact and facilitate efficient communications between the the client's clinical trial team and the sites
  • Perform remote and on-site monitoring/co-monitoring visits (Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits and Close-Out Visits) to ensure data integrity and subject safety in the client's trials
  • May perform oversight activities to assess monitoring quality and train/mentor less experienced CRAs
  • Promptly document monitoring activities and submit/approve visit reports
  • Manage site essential document collection and TMF reconciliation with site files
  • Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and confirm approvals
  • Regularly review site Key Risk Indicator (KRI) metrics, issues and action items to detect trends and ensure prompt resolution
  • Independently determine root causes and develop/implement site Corrective Action and Preventive Action (CAPA) plans
  • Deliver training to ensure sites comply with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) and regulations
  • Support sites and the client's regulatory inspections
  • Contribute to site identification; drive site feasibility and qualification progress; and support site activation activities
  • Lead site engagement initiatives and foster relationships with key Oncology sites and networks


Qualifications
  • Bachelor's degree (scientific field preferred)
  • 5+ years monitoring clinical trials independently conducting on-site and remote monitoring visits. Atleast 2 years monitoring solid tumor clinical trials.
  • 1+ years early development trial experience
  • Solid tumor clinical trial experience is required
  • Experience utilizing Veeva systems is highly preferred
  • Demonstrated experience developing/maintaining site relationships and securing compliance
  • Expertise in GxPs and Oncology monitoring techniques (including Risk-Based Monitoring) and terminology
  • Experience collaborating with sites from initial engagement through close-out phases
  • Experience activating sites
  • Experience training site staff
  • Experience supporting sites and/or sponsors in regulatory inspections
  • Experience working within a Functional Services (or in-house) monitoring model is preferred
  • Willing to travel up to 50%


Salary range: $110,520.00-$138,150.00

Bonus, Com, Stock, Benefits & Disclaimer verbiage:
Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level. You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance.

Are you a current ICON Employee? Please click here to apply

About Pharmaceutical Research Associates, Inc

Pharmaceutical Research Associates, Inc Careers

Joining Pharmaceutical Research Associates, Inc presents an unparalleled opportunity to become part of a leading team in the pharmaceutical research industry. This company stands as a beacon of innovation, leadership, and professional growth.

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Pharmaceutical Research Associates, Inc is actively seeking skilled professionals eager to impact the world of pharmaceuticals and healthcare. With a variety of job opportunities available, candidates can find positions that match their skills and career ambitions perfectly.

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At Pharmaceutical Research Associates, Inc, the culture thrives on diversity, innovation, and a commitment to employee growth. The company offers comprehensive benefits designed to support the health, well-being, and financial security of each team member. From diversity training to leadership programs, employees are equipped with resources to thrive both professionally and personally.

Internship Programs

For those starting their career journey, Pharmaceutical Research Associates, Inc provides robust internship programs. These opportunities allow interns to work alongside experienced professionals, gaining invaluable industry insight and enhancing their resume through practical, hands-on experience.

Professional Growth and Development

Career advancement is a cornerstone of employment at Pharmaceutical Research Associates, Inc. The company supports career growth through professional development programs, networking opportunities, and leadership training, ensuring that every team member has the tools to succeed.

Innovative Work Environment

Pharmaceutical Research Associates, Inc is at the forefront of pharmaceutical innovation. The team is dedicated to pioneering research that leads to new discoveries and solutions in healthcare, offering employees a chance to contribute to meaningful projects that push industry boundaries.

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Pharmaceutical Research Associates, Inc is hiring! Search open positions that align with your professional skills and interests. The company values curious, creative, and solution-driven team players ready to drive success in the pharmaceutical industry.

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Industry
Pharmaceuticals & Biotech
* Ladders Estimates

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