Clinical Research Associate/Senior

Posted Yesterday
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Hiring Remotely in Australia
Remote
Senior level
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
We’re in relentless pursuit of breakthroughs that change patients’ lives.
The Role
Lead site management and monitoring for clinical trials from start-up through closeout, ensuring GCP and regulatory compliance, patient safety, data integrity, and site performance. Conduct onsite/remote/risk-based monitoring, support enrollment, train site staff, escalate and resolve quality issues including CAPAs, mentor junior CRAs, and collaborate with cross-functional teams to deliver high-quality clinical research outcomes.
Summary Generated by Built In
Use Your Power for Purpose
Reporting to the ANZ GSSO Leadership, you will play a critical role in delivering high-quality clinical trials by partnering with investigator sites to ensure patient safety, regulatory compliance, and operational excellence. As a Senior Clinical Research Associate I you will serve as a trusted partner to investigators and study teams, leading site management and monitoring activities from study activation through closeout.
By building strong site relationships, proactively managing risks, resolving protocol-related issues, and supporting site performance, you will help accelerate the delivery of clinical research while maintaining the highest standards of quality and Good Clinical Practice. Working closely with Site Care Partners and cross-functional study teams, your expertise will contribute to successful enrollment, data integrity, database release, and the generation of evidence that advances innovative medicines for patients worldwide.
What You Will Achieve
In this role, you will:
  • Lead site management and monitoring activities across assigned clinical trial sites, ensuring studies are conducted in accordance with protocol, Good Clinical Practice (GCP), regulatory requirements, and Pfizer standards.
  • Serve as the primary point of contact for investigator sites, building strong partnerships to support high-quality study delivery and successful trial outcomes.
  • Manage site operations from study start-up through closeout, ensuring key milestones, timelines, and quality objectives are achieved.
  • Conduct onsite, remote, and risk-based monitoring activities, including site initiation, routine monitoring visits, and closeout visits.
  • Partner with Site Care Partners and cross-functional study teams to identify and mitigate risks, resolve site issues, and drive operational excellence.
  • Support patient recruitment and enrollment efforts by collaborating with investigators and study teams to address site-level challenges and implement recruitment strategies.
  • Provide protocol guidance, training, and coaching to investigator site personnel to ensure compliance, quality execution, and patient safety.
  • Develop and maintain strong scientific and operational knowledge of study protocols, investigational products, and therapeutic areas to effectively support investigators and site teams.
  • Drive the identification, escalation, and resolution of site quality, compliance, and data integrity issues, including implementation of corrective and preventive actions (CAPAs).
  • Monitor and support patient safety activities, including adverse event and serious adverse event reporting and follow-up.
  • Ensure timely completion and maintenance of essential study documentation, trial records, and regulatory compliance requirements throughout the study lifecycle.
  • Contribute to continuous improvement initiatives by mentoring junior CRAs, sharing best practices, and participating in local and regional process improvement projects.

Here Is What You Need (Minimum Requirements)
  • Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
  • Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations
  • Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
  • Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
  • Global clinical trial experience
  • Proficiency in English, both written and verbal
  • Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
  • Valid driver's license and passport required

Bonus Points If You Have (Preferred Requirements)
  • Master's degree with experience in early drug development.
  • Ability to manage multiple projects simultaneously
  • Strong analytical and problem-solving skills
  • Excellent communication and presentation skills
  • Experience using common AI tools, including generative technologies such
    as Microsoft Copilot or Gemini, to support problem solving and enhance

At Pfizer we care about our colleagues' wellbeing and offer a range of great benefits for them, including:
  • Paid parental leave
  • Access to Health & Wellness apps
  • Career Growth Experiences program
  • Recognition & rewards program
  • Paid volunteer days
  • Life Insurance Benefits
  • Pfizer Learning Academy access to top content providers
  • Access to flu vaccines & skin checks
  • Options to purchase additional leave
  • Salary packaging & novated lease options

*Benefits listed may vary depending on your position and location and may be subject to change.
Pfizer Australia and New Zealand's diverse workforce represents the patients we serve and the communities in which we operate. With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for. We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across: Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability and through the Out Pfizer Employee Network (OPEN) for our LGBT + colleagues and allies.
If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Medical

Skills Required

  • Bachelor's degree or professional degree in life sciences (nursing, pharmacy, medical) or equivalent
  • Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations
  • Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
  • Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
  • Global clinical trial experience
  • Proficiency in English, written and verbal
  • Significant travel (60-80%) within area; may require international and weekend travel
  • Valid driver's license and passport
  • Master's degree with experience in early drug development
  • Ability to manage multiple projects simultaneously
  • Strong analytical and problem-solving skills
  • Excellent communication and presentation skills
  • Experience using common AI tools, including generative technologies such as Microsoft Copilot or Gemini

What the Team is Saying

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Pfizer Compensation & Benefits Highlights

  • Healthcare Strength Multiple U.S. medical plan options include telehealth, comprehensive mental‑health support, fertility/family‑building benefits, transgender‑inclusive coverage, and certain Pfizer medications at no cost. A Wellbeing Wallet and wellness resources broaden the health and wellbeing offering.
  • Retirement Support A 401(k) with company matching is paired with an additional Pfizer Retirement Savings Contribution, alongside company‑paid life and disability insurance. One‑on‑one financial planning support is provided through Fidelity.
  • Leave & Time Off Breadth Paid time off spans vacation, holidays, and personal days, with additional caregiver and medical leave. U.S. parental leave commonly includes 12 weeks paid with options for additional unpaid bonding time and a return‑to‑work transition.

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The Company
HQ: New York, NY
121,990 Employees
Year Founded: 1848

What We Do

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Why Work With Us

We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.

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