Description
Syneos Health is seeking a Site Care Partner (Sponsor dedicated) to work in Buenos Aires. The successful candidate will have a minimum of 6 years of previous monitoring experience, ideally in Oncology.
The Site Care Partner will perform site qualification, site initiation, interim monitoring, site management, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance. They will use judgment and experience to evaluate the overall performance of the site and site staff and provide recommendations regarding site-specific actions.
Key responsibilities include:
- Performing site qualification, site initiation, interim monitoring, site management, and close-out visits
- Evaluating overall performance of site and site staff and providing recommendations
- 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 site source documents and medical records
- Applying query resolution techniques remotely and on-site
- 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
- Managing site-level activities and communication to ensure project objectives, deliverables, and timelines are met
- Providing guidance at the site and project level towards audit readiness standards
- May act 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
- Participating in and may lead global clinical monitoring/project staff meetings
- May provide direct supervision, training, and/or mentorship to more junior level CRAs
The ideal candidate will have:
- 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
- Excellent communication, presentation, and interpersonal skills
- Ability to manage required travel of up to 75% on a regular basis