Overview
Description
CRA II- SCRA I (Melbourne/ Sydney Home based). Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members apply their experience and deep expertise to understand customer needs and translate them into solutions. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with problem solvers to deliver for our customers and for those in need.
Discover what your 25,000 future colleagues already know:
Why Syneos Health
* We are 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.
* We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to shape solutions that have the ability to dramatically impact someone's life.
* We are continuously building the company we all want to work for and our customers want to work with. When we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
Job Responsibilities
* Performs site qualification, site initiation, interim monitoring, site management and close-out visits (on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment to evaluate site performance and provide recommendations; communicates/escalates serious issues and develops action plans. Maintains working knowledge of ICH/GCP Guidelines, relevant regulations, and SOPs/processes.
* Verifies informed consent processes and documentation, protects confidentiality, and assesses factors affecting subject safety and data integrity (protocol deviations/violations, pharmacovigilance issues).
* Per the CMP/SMP: assesses site processes; conducts source document review; verifies CRF data accuracy via site source documents; applies query resolution techniques remotely and on-site to closure within timelines.
* Utilizes available hardware/software to support study data review and capture; verifies site compliance with electronic data capture requirements.
* May perform investigational product (IP) inventory, reconciliation, storage and security reviews; ensures IP labeling, importation and release/return per GCP/local regulations and procedures.
* Reviews Investigator Site File (ISF) for accuracy and completeness; reconciles ISF with Trial Master File (TMF) and ensures archiving of essential documents per local guidelines.
* Documents activities via letters, reports, logs, and other required documents; supports recruitment, retention and awareness strategies; enters data into tracking systems to monitor observations and action items.
* Understands project scope, budgets, and timelines; manages site-level activities/communication to meet objectives; adapts to changing priorities.
* May act as primary liaison with project site personnel or with Central Monitoring; ensures sites and team members are trained and compliant.
* Prepares for and attends Investigator Meetings; participates in and may lead meetings and trainings as required.
* Provides guidance toward audit readiness and supports audit preparation and follow-up actions.
* May train or mentor junior CRAs; may perform training and sign-off visits for junior staff.
* May be mentored and assigned clinical operations lead tasks under supervision of experienced staff.
* For Real World Late Phase (RWLP), the Sr. CRA I will use the business-card title of Sr. Site Management Associate I. Additional responsibilities include site support throughout the study lifecycle, knowledge of local requirements for RWLP designs, chart abstraction and data collection, collaboration with Sponsor and local staff, identifying out-of-scope activities, suggesting sites, improving processes, developing country-level informed consent forms, and coordinating with RWLP Regulatory teams.
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 regulatory requirements
* Good computer skills and openness to new technologies
* Excellent communication, presentation and interpersonal skills; basic level of critical thinking
* Ability to travel up to 75% regularly
Additional Information
Discover what our more than 29,000 employees already know: work here matters everywhere. We work hard and smart to bring therapies to patients who need them. A career with Syneos Health means your everyday work improves patients' lives worldwide. We are committed to compliance with applicable laws and to providing reasonable accommodations when appropriate.
Syneos Health (Nasdaq:SYNH) is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.
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