Senior Clinical Research Associate
About the role
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
Responsibilities
- 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
Requirements
- 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 the West region; preference given to candidates residing in Los Angeles, Phoenix, Seattle, Denver or Portland, near major HUB airports to support efficient regional travel
Qualifications
- Graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN
- Eligible to work in United States without visa sponsorship
- 3+ years of on-site monitoring experience in the pharmaceutical or CRO industry
- Experience monitoring Oncology (i.e. Prostate Cancer, and Lung Cancer) and/or Hematology Oncology trials
- Proficiency in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
- Clear communication skills, problem-solving abilities, and collaborative teamwork
- Willingness and ability to travel up to 50% for on-site monitoring visits across the West region; preference given to candidates residing in Los Angeles, Phoenix, Seattle, Denver or Portland, near major HUB airports to support efficient regional travel
Skills
- Strong communication and interpersonal skills
- Ability to work independently and as part of a team
- Proficiency in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
- Excellent organizational and time management skills
- Ability to handle sensitive and confidential information
Benefits
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Pay
$110,520.00-$138,150.00
Schedule
Remote