Clinical Research Associate Level 1
Behavioral Health Market Context
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Job Description
ve treatments for patients.
Job Overview
The Clinical Research Associate I (CRA I) is crucial in facilitating and supporting the successful execution of clinical research studies. You will conduct site monitoring and management activities to ensure compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines, while always prioritizing patient safety and data integrity.
Key Responsibilities
In the role of CRA I, you will:
• Perform various monitoring visits, including site selection, initiation, routine monitoring, and close-out visits to evaluate the quality and integrity of site practices.
• Ensure adherence to regulatory requirements and sponsor expectations, while addressing quality concerns as needed.
• Review essential documents, assess protocol compliance, oversee data entry, and resolve queries.
• Maintain the Trial Master File (TMF) and the Investigator Site File (ISF) effectively.
• Develop strong communication with investigative sites, providing protocol training, setting expectations, and addressing challenges to meet enrollment goals.
• Collaborate closely with internal project teams for cohesive study execution and assist with site-level financial processes when necessary.
• Document all monitoring activities diligently, ensuring transparency and audit readiness through detailed monitoring visit reports and follow-up letters.
Effective time management and the ability to prioritize tasks while fostering collaborative team relationships is imperative for success in this role.
Qualifications
• Bachelor's degree required; a preference for candidates with a scientific or healthcare background.
• 6 months to 2 years of relevant experience, or equivalent training or completion of a CRA training program.
• Basic understanding of clinical research regulations (GCP/ICH).
• Willingness to travel as required by the project.
IQVIA stands out as a leading global provider of clinical research services and healthcare intelligence. We strive to accelerate the development of innovative medical treatments that enhance patient outcomes and public health on a global scale.
If you're ready to contribute to meaningful change and advance your career with us, we encourage you to apply.
IQVIA is committed to equal opportunity, welcoming applicants without regard to race, gender, disability, or veteran status.
Please be assured that we maintain integrity in our hiring process, and we ask all applicants to provide truthful and complete information.
The annual base pay for this role ranges from $71,900.00 to $119,900.00, with variations based on qualifications, experience, and location.
We seek diverse talent ready to join us on our mission to improve patient lives.
EEO Minorities/Females/Protected Veterans/Disabled
Job Overview
The Clinical Research Associate I (CRA I) is crucial in facilitating and supporting the successful execution of clinical research studies. You will conduct site monitoring and management activities to ensure compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines, while always prioritizing patient safety and data integrity.
Key Responsibilities
In the role of CRA I, you will:
• Perform various monitoring visits, including site selection, initiation, routine monitoring, and close-out visits to evaluate the quality and integrity of site practices.
• Ensure adherence to regulatory requirements and sponsor expectations, while addressing quality concerns as needed.
• Review essential documents, assess protocol compliance, oversee data entry, and resolve queries.
• Maintain the Trial Master File (TMF) and the Investigator Site File (ISF) effectively.
• Develop strong communication with investigative sites, providing protocol training, setting expectations, and addressing challenges to meet enrollment goals.
• Collaborate closely with internal project teams for cohesive study execution and assist with site-level financial processes when necessary.
• Document all monitoring activities diligently, ensuring transparency and audit readiness through detailed monitoring visit reports and follow-up letters.
Effective time management and the ability to prioritize tasks while fostering collaborative team relationships is imperative for success in this role.
Qualifications
• Bachelor's degree required; a preference for candidates with a scientific or healthcare background.
• 6 months to 2 years of relevant experience, or equivalent training or completion of a CRA training program.
• Basic understanding of clinical research regulations (GCP/ICH).
• Willingness to travel as required by the project.
IQVIA stands out as a leading global provider of clinical research services and healthcare intelligence. We strive to accelerate the development of innovative medical treatments that enhance patient outcomes and public health on a global scale.
If you're ready to contribute to meaningful change and advance your career with us, we encourage you to apply.
IQVIA is committed to equal opportunity, welcoming applicants without regard to race, gender, disability, or veteran status.
Please be assured that we maintain integrity in our hiring process, and we ask all applicants to provide truthful and complete information.
The annual base pay for this role ranges from $71,900.00 to $119,900.00, with variations based on qualifications, experience, and location.
We seek diverse talent ready to join us on our mission to improve patient lives.
EEO Minorities/Females/Protected Veterans/Disabled
Qualifications
- •IQVIA Biotech is actively seeking a Clinical Research Associate Level 1 (CRA 1) with at least 6 months of on-site monitoring experience, specifically in oncology solid tumors
- •Bachelor's degree required; a preference for candidates with a scientific or healthcare background
- •6 months to 2 years of relevant experience, or equivalent training or completion of a CRA training program
- •Basic understanding of clinical research regulations (GCP/ICH)
- •Willingness to travel as required by the project
Benefits
- •The annual base pay for this role ranges from $71,900.00 to $119,900.00, with variations based on qualifications, experience, and location
Responsibilities
- •The Clinical Research Associate I (CRA I) is crucial in facilitating and supporting the successful execution of clinical research studies
- •You will conduct site monitoring and management activities to ensure compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines, while always prioritizing patient safety and data integrity
- •Perform various monitoring visits, including site selection, initiation, routine monitoring, and close-out visits to evaluate the quality and integrity of site practices
- •Ensure adherence to regulatory requirements and sponsor expectations, while addressing quality concerns as needed
- •Review essential documents, assess protocol compliance, oversee data entry, and resolve queries
- •Maintain the Trial Master File (TMF) and the Investigator Site File (ISF) effectively
- •Develop strong communication with investigative sites, providing protocol training, setting expectations, and addressing challenges to meet enrollment goals
- •Collaborate closely with internal project teams for cohesive study execution and assist with site-level financial processes when necessary
- •Document all monitoring activities diligently, ensuring transparency and audit readiness through detailed monitoring visit reports and follow-up letters
- •Effective time management and the ability to prioritize tasks while fostering collaborative team relationships is imperative for success in this role
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