Clinical sites’ main point of contact, accountable for quality and delivery of sites from Initiation to Close out of the trial. Oversees the conduct of the trial at designated sites ensuring the rights and well-being of human subjects are protected, quality and integrity of the reported data and the conduct of the trial follows the currently approved protocol/amendment(s), with GCP and with the applicable regulatory requirement(s).● Build relationships with investigators and site staff… Show more Clinical sites’ main point of contact, accountable for quality and delivery of sites from Initiation to Close out of the trial. Oversees the conduct of the trial at designated sites ensuring the rights and well-being of human subjects are protected, quality and integrity of the reported data and the conduct of the trial follows the currently approved protocol/amendment(s), with GCP and with the applicable regulatory requirement(s).● Build relationships with investigators and site staff. ● Site contract negotiation and appropriate documents collection.● Conduct site qualification, initiation, monitoring, and close-out visits according to ICH-GCP, OCT/Sponsor SOPs, and applicable regulatory requirements.● Responsible for overall site management for assigned sites, including written and verbal communication and scheduling of monitoring visits.● Responsible for completion of visit reports, follow up letters, and maintenance of study-related databases.● Act as resource and facilitate training for new CRAs. Show less

Clinical sites’ main point of contact, accountable for quality and delivery of sites from Initiation to Close out of the trial. Oversees the conduct of the trial at designated sites ensuring the rights and well-being of human subjects are protected, the quality and integrity of the reported data and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP and with the applicable regulatory requirement(s).●Site contract negotiation and appropriate… Show more Clinical sites’ main point of contact, accountable for quality and delivery of sites from Initiation to Close out of the trial. Oversees the conduct of the trial at designated sites ensuring the rights and well-being of human subjects are protected, the quality and integrity of the reported data and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP and with the applicable regulatory requirement(s).●Site contract negotiation and appropriate documents collection.●Facilitate and support site with access to relevant study systems and ensure sites are compliant with project-specific training requirements. ●Address and resolve issues at sites.●Apply working knowledge and judgment to identify and evaluate potential data quality issues. ●Actively participate in Investigator and other external or internal meetings. ●Collect, review, and approve updated/amended site documentation, including regulatory documents as applicable.●Review site recruitment plan in collaboration with the site staff on an ongoing basis. ●Perform and report on-site visits and remote contacts in accordance with the monitoring plan; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions, and concerns.●Assess & manage test article/study supply including supply, accountability, and destruction/return status. ●Review & follow-up site payment status. ●Follow-up on CRF data entry.●Conduct on-site study-specific training.●Perform site facilities assessments●Maintains a sound working knowledge of and ensures compliance with applicable ICH-GCP Guidelines, international and local regulations, SOPs, and other Sponsor training requirements, and specific procedures, plans, and training. Actively participates in Investigator and other external or internal meetings.●Uses site management experience and understanding of clinical trials methodology to demonstrate problem solving. Show less

• Conduct the clinical monitoring aspect of designated projects • Perform clinical on-site monitoring activities (successful drive patient recruitment, source data verification, drug accountability, data collection), Audit experience.• Collect regulatory documentation• Perform qualification, initiation, monitoring and termination of investigational sites