Remote CRA: Site Monitoring & Study Management Expert

Syneos Health, Inc.; New Jersey; On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Company car or car allowance

Health benefits (Medical, Dental, Vis.

401k with company match

Employee Stock Purchase Plan

Bonus eligibility

Flexible PTO and sick time

Job summary

Syneos Health is seeking an Experienced Clinical Research Associate to support regionally aligned activities across the United States. The role involves on-site or remote monitoring, site management, and ensuring ICH-GCP compliance.

The candidate will verify informed consent processes, review site documents, manage IP inventory, and assist with site training and audit readiness. Up to 75% travel is expected.

Qualifications

• Bachelor's degree or RN in a related field.
• 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 CRF is accurate and complete.
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
• Routinely reviews the ISF for accuracy, timeliness and completeness. Reconciles contents of the ISF with the TMF.
• Documents activities via letters, logs, and other required project documents; supports recruitment and data tracking.

Skills

Travel up to 75%

Excellent communication

Interpersonal skills

Education

Bachelor's degree or RN

Job description

Syneos Health is seeking an Experienced Clinical Research Associate to support regionally aligned activities across the United States. The role involves on-site or remote monitoring, site management, and ensuring ICH-GCP compliance.

The candidate will verify informed consent processes, review site documents, manage IP inventory, and assist with site training and audit readiness. Up to 75% travel is expected.