Global Site Monitoring CRA – Remote/Onsite

Syneos Health, Inc.; Bismarck (ND); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Company car/allowance

Medical/Dental/Vision benefits

401k match

Employee stock purchase plan

Bonus eligibility

Paid time off

Sick time

Job summary

Syneos Health is seeking an Experienced Clinical Research Associate with regional alignment across the US. The CRA will perform site qualification, initiation, monitoring, and close-out visits, either on-site or remotely, ensuring ICH-GCP and GMP compliance.

The role requires travel up to 75% and involves coordinating with sites, reviewing ISF, IP handling, and audit readiness. The ideal candidate holds a Bachelor's degree or RN, has strong GCP knowledge, excellent communication skills, and

Qualifications

• Bachelor's degree or RN in a related field or equivalent
• 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 and close-out visits (on-site or remote) ensuring regulatory and protocol compliance
• Verifies informed consent process and protects subject confidentiality; assesses safety and data integrity factors
• Conducts Source Document Review and trend analyses; drives query resolution within timelines
• May handle IP inventory, reconciliation, and ensure proper labelling and release of IP
• Maintains ISF accuracy; reconciles with TMF and ensures archiving per guidelines
• Documents activities and supports recruitment, retention and data tracking
• Manages site-level activities to meet budgets and timelines; adapts to changing priorities
• Acts as liaison with study site personnel and trains site team members
• Prepares for Investigator Meetings and sponsor meetings; participates in trainings
• Provides audit readiness guidance and supports audit follow-up actions
• Maintains knowledge of ICH/GCP and company SOPs; completes required training
• For Real World Late Phase, Site Management Associate II responsibilities include site lifecycle support and training junior staff

Skills

Bachelor's degree or RN

GCP/ICH Guidelines knowledge

Strong computer skills

Excellent communication

Travel up to 75%

Education

Bachelor's degree or RN

Job description

Syneos Health is seeking an Experienced Clinical Research Associate with regional alignment across the US. The CRA will perform site qualification, initiation, monitoring, and close-out visits, either on-site or remotely, ensuring ICH-GCP and GMP compliance.

The role requires travel up to 75% and involves coordinating with sites, reviewing ISF, IP handling, and audit readiness. The ideal candidate holds a Bachelor's degree or RN, has strong GCP knowledge, excellent communication skills, and