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 southeast region; preference given to candidates residing in TN or KY near major HUB airports to support efficient regional travel
Qualifications
- Clear communication skills
- Problem-solving abilities
- Team player mentality
- Ability to travel up to 50%
Skills
- Strong knowledge of ICH-GCP and local regulatory requirements
- Experience in monitoring Oncology trials
- Excellent communication and collaboration skills
- Ability to travel up to 50%
Benefits
- Variety of annual leave entitlements
- A range of health insurance offerings
- Competitive retirement planning offerings
- Global Employee Assistance Programme
- Life assurance
- Flexible country-specific optional benefits
Pay
Details not specified
Schedule
Details not specified