Clinical Research Associate I​/II - Sponsor Dedicated - ONC + Gen Med; Home-Based

Clinical Research Associate I/II - Sponsor Dedicated - ONC + Gen Med (Home-Based in Central US)

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries 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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we create a place where everyone feels like they belong.

• 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. Evaluates site and staff performance and provides recommendations; communicates/escalates serious issues to the project team and develops action plans. Maintains working knowledge of ICH/GCP Guidelines or other applicable guidance, regulations, and SOPs/processes.
• Verifies informed consent processes are adequately performed and documented; protects confidentiality; assesses factors affecting subject safety and data integrity at investigator/physician sites (e.g., protocol deviations/violations, pharmacovigilance issues).
• Per CMP/SMP: assesses site processes; conducts source document review of site source documents and medical records; verifies CRF data accuracy/completeness; applies query resolution techniques remotely and on-site; drives query resolution to closure; supports data review and capture; verifies site compliance with electronic data capture requirements.
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security; verifies IP dispensing and administration per protocol; manages issues/risks related to blinded or randomized IP information; ensures IP labelling, import/export in line with GCP/local regulations.
• Routinely reviews the Investigator Site File (ISF) for accuracy and completeness; reconciles ISF with Trial Master File (TMF); ensures archiving of essential documents per local guidelines and regulations.
• Documents activities via confirmation letters, follow-up letters, trip reports, communications logs, and other required project documents; supports subject/patient recruitment and retention; enters data into tracking systems to monitor observations, status and action items.
• Understands project scope, budgets, and timelines; manages site-level activities/communication to meet objectives; adapts to changing priorities to achieve goals.
• May act as primary liaison with study site personnel or with Central Monitoring Associate; ensures all assigned sites and team members are trained and compliant with requirements.
• Prepares for and attends Investigator Meetings and sponsor meetings; participates in global clinical monitoring/project staff meetings and attends training as required.
• Provides guidance toward audit readiness and…