Remote Clinical Research Associate - Full-Service

Syneos Health, Inc.; Illinois; Hybrid; USD 70,000 - 100,000; Full time

Benefits offered by this job

Company car/allowance

Health benefits

401k match

Stock Purchase Plan

Bonuses

Job summary

Syneos Health, Inc. is seeking a Clinical Research Associate - Full-Service to support global trials with remote monitoring, site qualification, initiation and close-out visits, ensuring regulatory compliance and data integrity across studies in the US.

As a CRA, you will verify informed consent, manage site communications, review ISF/TMF, assist with recruitment and tracking, and travel up to 75% to sites as required while embracing new technologies and GCP standards.

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
• US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession.

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 and protects confidentiality.
• Per the CMP/SMP: Assesses site processes and conducts Source Document Review; verifies required data in CRF; applies query resolution remotely and on site.
• May perform IP inventory, reconciliation and reviews storage and security; ensures IP labeling, import and release.
• Routinely reviews ISF for accuracy, timeliness and completeness; reconciles with TMF; ensures archiving of essential documents.
• Documents activities via letters, logs and reports; supports recruitment and data tracking.
• Manages site-level activities to meet project objectives and timelines; adapts to changing priorities.
• May act as primary liaison with study site personnel and ensure training and compliance.

Skills

Communication

Computer skills

Travel readiness

Interpersonal skills

Education

Bachelor's degree or RN

Job description

Syneos Health, Inc. is seeking a Clinical Research Associate - Full-Service to support global trials with remote monitoring, site qualification, initiation and close-out visits, ensuring regulatory compliance and data integrity across studies in the US.

As a CRA, you will verify informed consent, manage site communications, review ISF/TMF, assist with recruitment and tracking, and travel up to 75% to sites as required while embracing new technologies and GCP standards.