Remote Clinical Research Associate — Accelerate Therapies

Syneos Health, Inc.; Arizona; Hybrid; USD 65,000 - 90,000; Full time

Job summary

Syneos Health is seeking a Clinical Research Associate for Full-Service supporting remote monitoring across sites in the United States. Responsibilities include site qualification, initiation, interim monitoring, and close-out visits, performed on-site or remotely.

The role requires a Bachelor’s degree or RN, knowledge of ICH-GCP, excellent communication, and the ability to travel up to 75% regularly. This is a position with a leading biopharmaceutical solutions organization.

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.

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): Assess site processes. Conduct Source Document Review of appropriate site source documents and medical records. Verify required clinical data entered in the case report form (CRF) is accurate and complete.
• 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.

Skills

Communication skills

Interpersonal skills

GCP/ICH knowledge

Computer skills

Education

Bachelor’s degree or RN in related field

Job description

Syneos Health is seeking a Clinical Research Associate for Full-Service supporting remote monitoring across sites in the United States. Responsibilities include site qualification, initiation, interim monitoring, and close-out visits, performed on-site or remotely.

The role requires a Bachelor’s degree or RN, knowledge of ICH-GCP, excellent communication, and the ability to travel up to 75% regularly. This is a position with a leading biopharmaceutical solutions organization.