Implement necessary activities required for setting up and monitoring a study, completing accurate study status reports and maintaining study documentation. Conducted Onsite Competency Evaluations (OCE's), Involved in the submission of protocol, consent documents for ethics/IRB approval, and assist in the preparation of regulatory submissions as needed. Dedicated to Rare Deisease Studies.

Manage and execute the timely implementation of clinical research activities for assigned studies sites across North America. Performing clinical monitoring activities (site evaluation, initiation, interim monitoring visits, remote, and close-out) in compliance with Good Clinical Practices (GCP) and applicable regulations.

Responsible for site management and monitoring activities at assigned sites across assigned projects and ensuring the trial is conducted in compliance with the protocol, ICH/GCP, applicable regulatory requirements, and applicable SOPs or Work Instructions.

Independently and proactively coordinate all necessary activities required for setting up and monitoring a study, completing accurate study status reports and maintaining study documentation. Conducted Onsite Competency Evaluations (OCE's), Involved in the submission of protocol, consent documents for ethics/IRB approval, and assist in the preparation of regulatory submissions as needed. Dedicated to Vaccine studies: COVID19 and Botulism.

Manages all North America regional clinical operational and quality aspects of allocated studies, in compliance with ICH GCP. Works together with the North American clinical team to meet project deliverables. Ensures the implementation and training of standardized clinical monitoring processes within the study are completed across North America, per standard operating policies. Verifies timelines, resources, interactions, and quality are kept. Responsible for overseeing the archiving of documents and study materials within trial master file in a timely manner. Regularly reviews North America projects, using tracking and management tools and managing CRF collection and query resolution.

Independently and proactively coordinate all necessary activities required for setting up and monitoring a study, completing accurate study status reports and maintaining study documentation. Involved in the submission of protocol, consent documents for ethics/IRB approval and assist in the preparation of regulatory submissions as needed.

Manages all clinical operational and quality aspects of allocated studies, in compliance with ICH GCP. Works together with the clinical team to meet project deliverables. Ensures the implementation and training of standardized clinical monitoring processes within the study are completed per standard operating policies. Verifies timelines, resources, interactions, and quality are kept and. Responsible for overseeing the archiving of documents and study materials within trial master file in a timely manner. Regularly reviews projects using tracking and management tools and managing CRF collection and query resolution.

Completes project activities associated with site management and monitoring functions for Phase I-IV clinical research studies. Conducts study feasibility and site selection activities. Develops and implement innovative approaches for and participates in site recruitment, selection and initiation activities. Performs investigator site management activities, in adherence to all applicable regulatory guidelines and standard operating procedures (SOPs).

Monitor ophthalmic drug and device trials and manage site-sponsor relationships with a focus on Dry Eye, Glaucoma, External Disease, Cataracts, Intraocular Lenses, Diabetic Retinopathy and Age Related Macular Degeneration; ensure subject safety, protocol adherence and data integrity. Provide site management support to ensure adherence to FDA regulations, ICH/GCP and ISO standards.

-Oversee the management and administration of all aspects of clinical trials/studies involved in each step of the clinical trial/study.-Assist with preparation of protocols and other necessary documents required for trial approval by HA.-Prepare protocols and other necessary documents required for trial approval by EC and getting EC approval on time.-Monitor and coordinate the clinical trial conduction in whole process by following GCP and SOP strictly.-Make monitoring plan, co-monitoring plan, budget and tracking plan and follow it during trial process.-Track progress, status and performance regularly, find current problems/issues and make appropriate action plans.-Coordinate and giving input to all activities including query resolution, site closure and collection of documentation required for clinical trial reports after trail end.-Ensure but not limited to, IMPACT, EDC system for administration of clinical trials is updated in a timely and accurate manner in accordance with requirements.-Ensure all SAEs/adverse drug reactions are reported and followed up in a timely manner according to internal relevant SOP-Maintain, update and archive all clinical trial files on time.-Maintain up to date knowledge of diabetes treatment, company products, and clinical trial conduction.-Coach CRA from technical point.-All other responsibilities and duties which may be required as needed

-Take responsibility for specific tasks on projects, or acts as the main CRA contact on individual projects-Train team members on selected tasks-Keep manager informed about work progress and any issues to avoid surprises.-Build relationships with investigators and site staff-Participate in Investigator and other external or internal meetings as required-Arrange on-site visits and logistics (e.g. travel arrangements)-Perform on site visits in accordance with the monitoring plan-Conduct on-site study-specific training (if applicable)-Perform site facilities inspection-Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations-Monitor and maintain ICH-GCP compliance-Responsible for the completeness and quality of the on-site files-Respond to site issue alerted from Clinical Monitoring Associate such as non-responsive site, Protocol Deviations concerns, quality issues etc...-Collect SRP documents during QV and other visits as needed-Establish site recruitment plan in collaboration with site during Qualification Visit; follow-up and update at Initiation Visit and Monitoring Visit-Update all relevant tracking system on an ongoing basis-Collaborate with CMA on site issues/actions-Generate visit/contact report in accordance with monitoring plan-Code and scan Central File documents where applicable-Ship relevant wet-ink signature documents to the Assistant or back to the site-Escalate any issues that require immediate action to the CRA Coordinator/GRO Lead-Attend audits / Regulatory Inspection if requested