Remote Clinical Research Associate Site Monitoring Expert

Syneos Health, Inc.; Santa Fe (NM); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Company car or car allowance

Health benefits (Medical, Dental, and

Job summary

Syneos Health in the United States is seeking an Experienced Clinical Research Associate to support monitoring activities across clinical sites. The role involves site qualification, initiation, interim monitoring, and close-out visits, performed on-site or remotely, while ensuring adherence to ICH-GCP and applicable regulations.

You will verify informed consent, protect patient confidentiality, and assess site processes and data integrity.

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, as required/appropriate.
• 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 case report form (CRF) is accurate and complete.
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies IP has been dispensed and administered to subjects/patients according to the protocol.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles ISF with TMF.

Skills

Communication skills

Presentation skills

Interpersonal skills

Travel willingness

Education

Bachelor's degree or RN

Job description

Syneos Health in the United States is seeking an Experienced Clinical Research Associate to support monitoring activities across clinical sites. The role involves site qualification, initiation, interim monitoring, and close-out visits, performed on-site or remotely, while ensuring adherence to ICH-GCP and applicable regulations.

You will verify informed consent, protect patient confidentiality, and assess site processes and data integrity.