[Hiring] Sr CRA I/II @Syneos Health

Role Description

The Sr CRA I/II will perform site qualification, site initiation, interim monitoring, site management, and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance. Responsibilities include:

• Evaluating overall performance of site and site staff, providing recommendations for site-specific actions.
• Communicating/escalating serious issues to the project team and developing action plans.
• Maintaining knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.
• Verifying informed consent has been adequately performed and documented for each subject/patient.
• Protecting the confidentiality of each subject/patient.
• Assessing factors affecting subject/patient safety and clinical data integrity.
• Conducting Source Document Review of appropriate site source documents and medical records.
• Verifying clinical data accuracy and completeness via review of site source documents and medical records.
• Applying query resolution techniques and providing guidance to site staff.
• Utilizing hardware and software for effective clinical study data review and capture.
• Performing investigational product (IP) inventory and reconciliation.
• Reviewing the Investigator Site File (ISF) for accuracy, timeliness, and completeness.
• 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 and communication to ensure project objectives are met.
• Acting as primary liaison with study site personnel.
• Preparing for and attending Investigator Meetings and sponsor meetings.
• Providing guidance towards audit readiness standards.
• May supervise, train, and mentor junior level CRAs.
• For Real World Late Phase (RWLP), responsibilities include:
• Site support throughout the study lifecycle.
• Chart abstraction activities and data collection.
• Collaborating with Sponsor and other affiliates.
• Training junior staff as required.
• Identifying and communicating out of scope activities.
• Proposing potential sites based on local knowledge.
• Identifying operational efficiencies and process improvements.
• Developing informed consent forms.
• Collaborating with RWLP Regulatory team.
• Participating in bid defense meetings.
• Providing input into Requests for Proposals (RFPs).
• Participating in Case Report Form design.

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.
• Demonstrated computer skills and ability to embrace new technologies.
• Excellent communication, presentation, and interpersonal skills.
• Moderate level of critical thinking skills expected.
• Ability to manage required travel of up to 75% on a regular basis.

Company Description

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change, and accelerate progress.

• Passionate about developing our people through career development and progression.
• Committed to building an inclusive culture where you can authentically be yourself.
• Continuously building the company we all want to work for and our customers want to work with.