Remote CRA: Global Clinical Research Oversight

Syneos Health, Inc.; Texas; On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Company car or car allowance

Health benefits (medical, dental, or/&

Company match 401k

Employee Stock Purchase Plan

Bonus eligibility

Job summary

Syneos Health, Inc. is seeking an Experienced Clinical Research Associate aligned across the US to monitor sites, manage regulatory compliance, and support close-out visits both on-site and remotely.

The role emphasizes ICH-GCP knowledge, data integrity, and robust site collaboration to ensure trials progress on time. As part of a collaborative team, you will engage in site qualification, monitoring planning, and investigator meetings, with significant travel and strong focus on audit readiness

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. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk.

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 as per SOPs and Clinical Monitoring Plan/Site Management Plan.
• 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 assigned training as required. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II.

Skills

GCP knowledge

Excellent communication

Travel readiness

Education

Bachelor's degree or RN

Job description

Syneos Health, Inc. is seeking an Experienced Clinical Research Associate aligned across the US to monitor sites, manage regulatory compliance, and support close-out visits both on-site and remotely.

The role emphasizes ICH-GCP knowledge, data integrity, and robust site collaboration to ensure trials progress on time. As part of a collaborative team, you will engage in site qualification, monitoring planning, and investigator meetings, with significant travel and strong focus on audit readiness