Senior Clinical Research Associate I - Remote (FSP)

About the role

Syneos Health is hiring a Sponsor Dedicated FSP Senior CRA I for a remote position. The role covers site qualification, initiation, interim monitoring, site management and close-out visits, performed on-site or remotely, and includes chart review, query resolution and site compliance checks. For Real World Late Phase (RWLP) studies, the business card title is Sr. Site Management Associate I.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits, evaluating site performance and escalating serious issues
• Verify informed consent, protect subject confidentiality and assess factors affecting safety and data integrity
• Review source documents and medical records, verify CRF data accuracy and completeness, and resolve queries remotely and on site
• Check site compliance with electronic data capture requirements and, if needed, review investigational product inventory, dispensing and labelling
• Maintain the Investigator Site File and reconcile it with the Trial Master File
• Document activities, support recruitment and retention, enter data into tracking systems and manage site-level communication
• Act as liaison with site personnel, prepare for and attend investigator and sponsor meetings, and guide sites toward audit readiness
• Train and mentor junior CRAs, and may be mentored by an experienced Clinical Operations Lead
• Additional duties: site support throughout the study lifecycle, chart abstraction, country-level informed consent forms, bid defence meetings, and suggesting potential sites

Required profile

• Bachelor's degree or RN in a related field, or equivalent education, training and experience
• Good computer skills and willingness to adopt new technologies
• Excellent communication, presentation and interpersonal skills, and basic critical thinking
• Ability to travel regularly up to 75%

Required skills

• Knowledge of Good Clinical Practice (ICH-GCP) and other applicable regulatory requirements
• ICH-GCP and ICH guidelines