[Hiring] Single Sponsor CRA II @Syneos Health

Role Description

The Single Sponsor CRA II will perform 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.

• Uses judgment and experience to evaluate overall performance of site and site staff.
• Communicates/escalates serious issues to the project team and develops action plans.
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
• Demonstrates diligence in protecting the confidentiality of each subject/patient.
• Assesses factors affecting subject/patient’s safety and clinical data integrity.
• Conducts Source Document Review of appropriate site source documents and medical records.
• Verifies required clinical data entered in the case report form (CRF) is accurate and complete.
• Applies query resolution techniques remotely and on site, providing guidance to site staff.
• Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture.
• 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.
• Supports subject/patient recruitment, retention and awareness strategies.
• Understands project scope, budgets, and timelines; manages site-level activities/communication.
• May act as primary liaison with study site personnel.
• 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.
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II.
• Additional responsibilities include site support throughout the study lifecycle from site identification through close-out.

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.

Requirements

• 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.
• You are required to comply with any such Site requests as a condition of your employment with Syneos Health.

Benefits

• We are passionate about developing our people through career development and progression.
• We are committed to building an inclusive culture where you can authentically be yourself.
• We continuously build the company we all want to work for and our customers want to work with.

Company Description

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.