Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator.
You''ll be supported with comprehensive resources based on today''s emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you''ll gain exposure and work in a dynamic environment to over-deliver and outperform.
A career with Syneos Health means your everyday work improves patients’ lives around the world.
The Clinical Research Associate I (CRA I) will be sponsored based in Buenos Aires - Argentina and will perform clinical monitoring activities in accordance with study guidelines, SOPs, and applicable regulations/guidance documents.
* Perform site qualification, site initiation, interim monitoring, and close-out visits ensuring regulatory and protocol compliance. Visits may be performed on-site or remotely. * Review completion of proper informed consent procedures. * Ensure accurate data reporting via review of site source documents and medical records. * Interpret data to identify protocol deviations and risks to subject safety/data integrity. * Generate queries and manage resolutions with site personnel. * Perform investigational product accountability as per the protocol and Study Monitoring Plan. * Evaluate execution of study protocol at the site level. Use judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicate/escalate serious issues to the project team. * Obtain, review, and process essential regulatory and administrative documents. Conduct audits of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance. * Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documents as per SOPs and Study Monitoring Plan. * Understand project scope, budgets, and timelines; manage site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing variables to achieve goals / targets. * Enter data into tracking systems as required. * Act as primary liaison with study site personnel. * Participate in the identification and selection of investigators and clinical sites. * Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; complete assigned training as required. * May interact with representatives of client affiliates as per project requirements. * Provide clinical and technical support for project team as required.
& & EDUCATION REQUIRED:
* Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
MINIMUM TRAINING & PREFERRED EXPERIENCE:
* Minimum of 1 year of prior clinical research or monitoring experience, OR graduates of the iHC Monitoring Foundations program * Knowledge of Good Clinical Practice (GCP)/ICH Guidelines and other applicable regulatory requirements * Strong organizational skills * Must demonstrate good computer skills * Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade * A good command of the English language both verbal and written * Ability to travel as necessary up to 70% depending on assignment. Overnight and occasional weekend travel may be required.
BENEFITS: Competitive remuneration package with excellent benefits Commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization Opportunity to work within a successful and rewarding environment