Remote Clinical Research Associate — Global Trials

Syneos Health, Inc.; Plano (TX); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Company car or car allowance

Health benefits (Medical, Dental, and

401k match

Employee Stock Purchase Plan

Bonus eligibility

Flexible PTO & paid sick time

Job summary

Syneos Health is seeking an Experienced Clinical Research Associate to support a regionally aligned monitoring program across the US. You will perform site qualification, initiation, monitoring, and close-out visits, on-site or remotely, ensuring ICH-GCP compliance and data integrity.

You will partner with investigators and site staff, review ISF/TMF, support patient safety, and contribute to timelines and budgets. Travel up to 75% may be required; a Bachelor's degree or RN is required.

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.

Responsibilities

• Performs site qualification, 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; assesses factors affecting subject safety and data integrity.
• Per CMP/SMP: assesses site processes; conducts source document review; ensures accurate CRF data; guides site staff to resolve queries.
• May perform IP inventory, reconciliation and review of storage and security; ensures proper labeling, import/release per protocol.
• Routinely reviews ISF for accuracy and TMF alignment; supports archiving per guidelines; tracks observations and action items.

Education

Bachelor's degree or RN in a related field or equivalent combination of education, training and experience

Job description

Syneos Health is seeking an Experienced Clinical Research Associate to support a regionally aligned monitoring program across the US. You will perform site qualification, initiation, monitoring, and close-out visits, on-site or remotely, ensuring ICH-GCP compliance and data integrity.

You will partner with investigators and site staff, review ISF/TMF, support patient safety, and contribute to timelines and budgets. Travel up to 75% may be required; a Bachelor's degree or RN is required.