Senior Clinical Research Associate

Posted 13 Hours Ago
Be an Early Applicant
2 Locations
In-Office or Remote
Senior level
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
Serve as primary contact between investigational sites and sponsor; conduct site visits (selection, initiation, routine monitoring, close-out); ensure ICH-GCP and regulatory compliance; maintain CTMS and eTMF documentation; monitor patient safety and AE/SAE reporting; support recruitment, drug accountability, data quality, site training, budgets, and escalate risks to clinical team.
Summary Generated by Built In
Senior Clinical Research Associate - Oncology - Knoxville, TN

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.


As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.


What You Will Be Doing:

  • Serve as the primary point of contact between investigational sites and the sponsor

  • Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out

  • Ensure site compliance with ICH-GCP, SOPs, and regulations

  • Maintain up-to-date documentation in CTMS and eTMF systems

  • Support and track site staff training and maintain compliance records

  • Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting

  • Support subject recruitment and retention efforts at the site level

  • Oversee drug accountability and ensure proper storage, return, or destruction

  • Resolve data queries and drive timely, high-quality data entry

  • Document site progress and escalate risks or issues to the clinical team

  • Assist in tracking site budgets and ensuring timely site payments (as applicable)

  • Collaborate with cross-functional partners including CTAs, LTMs, and CTMs

You are:

  • A graduate with a Bachelor’s degree in Life Sciences or equivalent, or a qualified RN

  • Eligible to work in United States without visa sponsorship

  • A clinical research professional with 3+ years of on-site monitoring experience in the pharmaceutical or CRO industry

  • Experienced monitoring Oncology (i.e. Prostate Cancer, and Lung Cancer) and/or Hematology oncology trials

  • Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF

  • A clear communicator, problem-solver, and collaborative team player

  • Willing and able to travel up to 50% for on-site monitoring visits across southeast region; preference given to candidates residing in Knoxville, TN near major HUB airports to support efficient regional travel


Employment with ICON is contingent upon having the legal right to work in the country where the role is based.


Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.


Benefits may include:

  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.


Visit our careers site to read more about the benefits ICON offers.


Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.


If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

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

Skills Required

  • Bachelor's degree in Life Sciences or equivalent, or qualified RN
  • Authorized to work in the United States without visa sponsorship
  • 3+ years of on-site monitoring experience in the pharmaceutical or CRO industry
  • Experience monitoring Oncology and/or Hematology oncology trials (e.g., prostate, lung cancer)
  • Proficiency with ICH-GCP and local regulatory requirements
  • Experience using clinical systems such as CTMS and eTMF
  • Willingness and ability to travel up to 50% for regional on-site monitoring
  • Preference for residing near Knoxville, TN (near major hub airports) to support regional travel
  • Strong communication, problem-solving, and teamwork skills

ICON plc Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ICON plc and has not been reviewed or approved by ICON plc.

  • Healthcare Strength Benefits are described as comprehensive, with medical coverage and wellness initiatives highlighted. Larger sites are also associated with added wellness supports such as onsite fitness options and access to an employee assistance program.
  • Leave & Time Off Breadth Time-off and flexibility provisions are positioned as a meaningful part of the total package, including vacation/annual leave and flexible work scheduling. Flexibility is sometimes cited as helping offset long hours in certain roles.
  • Retirement Support Retirement and savings support is presented as a core component of the benefits package, including offerings such as pension arrangements in some locations and a U.S. 401(k) plan with company match. Financial planning resources are also emphasized as part of broader security benefits.

ICON plc Insights

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The Company
HQ: Dublin
34,685 Employees
Year Founded: 1990

What We Do

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.

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