Remote Clinical Research Associate: Site Monitoring

Syneos Health, Inc.; Billings (MT); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Company car/allowance

Health benefits (Medical, Dental, Vis

401k match

Employee Stock Purchase Plan

Bonus eligibility

Flexible PTO

Job summary

Syneos Health is seeking an Experienced Clinical Research Associate to be regionally aligned across the US. This role focuses on site qualification, initiation, monitoring, and close-out visits while ensuring GCP compliance and data integrity.

You will verify informed consent processes, manage site documents, and support site staff to maintain audit readiness. A Bachelor’s degree or RN is required, with up to 75% travel and strong communication skills.

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, 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 Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records.
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents.
• For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.
• May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate.
• Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes training as required.

Skills

Regulatory knowledge

Clinical monitoring

Communication skills

Travel readiness

Computer proficiency

Education

Bachelor’s degree or RN

Job description

Syneos Health is seeking an Experienced Clinical Research Associate to be regionally aligned across the US. This role focuses on site qualification, initiation, monitoring, and close-out visits while ensuring GCP compliance and data integrity.

You will verify informed consent processes, manage site documents, and support site staff to maintain audit readiness. A Bachelor’s degree or RN is required, with up to 75% travel and strong communication skills.