[Hiring] Clinical Research Associate I @Syneos Health

Role Description

The CRA I 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. Responsibilities include:

• Using judgment and experience to evaluate overall performance of site and site staff.
• Communicating/escalating serious issues to the project team and developing action plans.
• Maintaining a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifying the process of obtaining informed consent has been adequately performed and documented.
• Assessing factors that might affect subject/patient’s safety and clinical data integrity.
• Conducting Source Document Review of appropriate site source documents and medical records.
• Verifying required clinical data entered in the case report form (CRF) is accurate and complete.
• Applying query resolution techniques remotely and on site, providing guidance to site staff.
• Utilizing available hardware and software to support the effective conduct of the clinical study data review and capture.
• Verifying site compliance with electronic data capture requirements.
• Performing investigational product (IP) inventory, reconciliation, and reviewing storage and security.
• Documenting activities via confirmation letters, follow-up letters, trip reports, and communication logs.
• Supporting subject/patient recruitment, retention, and awareness strategies.
• Managing site-level activities/communication to ensure project objectives, deliverables, and timelines are met.
• Acting as primary liaison with study site personnel or in collaboration with Central Monitoring Associate.
• Preparing for and attending Investigator Meetings and/or sponsor face-to-face meetings.
• Providing guidance at the site and project level towards audit readiness standards.
• Maintaining a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.

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

• Compliance with site requests for medical and personal information as a condition of employment.

Benefits

• Passionate about developing our people through career development and progression.
• Supportive and engaged line management.
• Technical and therapeutic area training.
• Peer recognition and total rewards program.
• Commitment to building an inclusive culture.