Remote Regional Clinical Research Associate

Syneos Health, Inc.; Georgia; Hybrid; USD 85,000 - 110,000; Full time

Job summary

Syneos Health is seeking an Experienced Clinical Research Associate to support regionally aligned monitoring across the United States. The CRA II will ensure regulatory compliance with ICH-GCP and study protocols, maintain site performance, and collaborate with investigators, sponsor teams and site staff to accelerate trial delivery.

Responsibilities include site qualification and initiation visits, monitoring, data queries, and archiving essential documents.

Qualifications

• Bachelor's degree or RN in a related field or equivalent combination of education, training and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Must demonstrate good computer skills and be able to embrace new technologies.
• Excellent communication, presentation and interpersonal skills.
• Ability to manage required travel of up to 75% on a regular basis.

Responsibilities

• Performs site qualification, initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
• Verifies the process of obtaining informed consent and protects patient confidentiality; assesses factors affecting safety and data integrity.
• Assesses site processes, conducts source document review, and ensures data entry accuracy in CRFs; drives query resolution to closure.
• May perform IP inventory, labeling, storage checks and ensure IP handling per protocol and regulatory requirements.
• Reviews ISF and TMF, ensuring archiving per local guidelines; supports recruitment and data tracking.
• Manages project scope, budgets and timelines; travels as required and communicates with sites and sponsor teams.

Skills

Excellent communication

Interpersonal skills

Travel up to 75%

Computer skills

GCP/ICH knowledge

Education

Bachelor's degree or RN in a related field

Job description

Syneos Health is seeking an Experienced Clinical Research Associate to support regionally aligned monitoring across the United States. The CRA II will ensure regulatory compliance with ICH-GCP and study protocols, maintain site performance, and collaborate with investigators, sponsor teams and site staff to accelerate trial delivery.

Responsibilities include site qualification and initiation visits, monitoring, data queries, and archiving essential documents.