Experienced Clinical Research Associate — Remote/Field

Syneos Health, Inc.; Colorado Springs (CO); On-site; USD 60,000 - 100,000; Full time

Benefits offered by this job

Company car or car allowance

Health benefits (medical, dental, and/

401(k) company match

Employee Stock Purchase Plan

Bonuses/commissions

Flexible PTO and sick time

Job summary

Syneos Health in the United States seeks an Experienced Clinical Research Associate (CRA) aligned across the US. The role focuses on site qualification, initiation, monitoring, and close-out visits, performed on-site or remotely, ensuring ICH-GCP and regulatory compliance.

You will also support IP handling, ISF/TMF reconciliation, and patient recruitment strategies in a dynamic, patient-centric environment.

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, site 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 has been adequately performed and documented for each subject/patient.
• Per the CMP/SMP: Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the CRF is accurate and complete.
• May perform IP inventory, reconciliation and reviews storage and security. Verifies IP is dispensed and administered according to the protocol.
• Routinely reviews the ISF for accuracy, timeliness and completeness. Reconciles with the TMF.
• Documents activities via confirmation letters and project documents; supports recruitment, retention and tracking.
• Understands project scope, budgets and timelines; manages site-level activities and communication.
• Acts as liaison with study site personnel; ensures training and compliance.
• Prepares for Investigator Meetings and sponsor meetings; participates in global meetings and training.
• Provides guidance at site and project level towards audit readiness and follow-up actions.
• Maintains knowledge of ICH/GCP Guidelines and completes required training.
• For Real World Late Phase, Site Management Associate II responsibilities including site support, chart abstraction, and collaboration with sponsor affiliates.

Skills

Communication skills

Presentation skills

Interpersonal skills

Computer skills

Travel readiness

Education

Bachelor's degree or RN in a related field

Equivalent combination of education, training and experience

Job description

Syneos Health in the United States seeks an Experienced Clinical Research Associate (CRA) aligned across the US. The role focuses on site qualification, initiation, monitoring, and close-out visits, performed on-site or remotely, ensuring ICH-GCP and regulatory compliance.

You will also support IP handling, ISF/TMF reconciliation, and patient recruitment strategies in a dynamic, patient-centric environment.