I O Email & Phone Number

United States

1. Clinical Trial Oversight:- Monitor and conduct site visits to ensure compliance with study protocols, GCP (Good Clinical Practice), and applicable regulatory guidelines.- Review and verify data accuracy, source documentation, and case report forms (CRFs) for completeness and consistency.- Identify and address any issues or deviations from the study protocol, taking appropriate corrective and preventive actions.- Collaborate with investigators, site staff, and study… Show more 1. Clinical Trial Oversight:- Monitor and conduct site visits to ensure compliance with study protocols, GCP (Good Clinical Practice), and applicable regulatory guidelines.- Review and verify data accuracy, source documentation, and case report forms (CRFs) for completeness and consistency.- Identify and address any issues or deviations from the study protocol, taking appropriate corrective and preventive actions.- Collaborate with investigators, site staff, and study coordinators to provide support and ensure smooth study conduct.2. Site Management and Relationship Building:- Establish and maintain strong relationships with investigative sites, fostering effective communication and cooperation.- Provide training and guidance to site personnel on study procedures, protocol requirements, and data collection methods.- Act as the main point of contact for sites, addressing their queries and concerns promptly.3. Regulatory Compliance:- Ensure adherence to all relevant regulatory guidelines and local/international standards.- Participate in preparing, submitting, and maintaining regulatory documentation, including IRB/EC (Institutional Review Board/Ethics Committee) submissions.4. Data Management:- Ensure accurate and timely data collection, verification, and entry into the study database.- Assist in data cleaning and query resolution processes.5. Study Documentation:- Maintain comprehensive and organized study documentation, including study files and records.- Prepare monitoring visit reports, progress updates, and other study-related documentation as required.6. Team Collaboration:- Collaborate with cross-functional teams, including project managers, clinical trial managers, biostatisticians, and medical monitors.- Participate in study team meetings and contribute to study planning and progress discussions. Show less

United States

● Independently resolved protocol questions with the Project Manager (PM) and patient-related issues with the Medical Monitor (MM).● Routinely anticipates/identifies potential issues and implements corrective actions independently. ● Kept project leadership apprised of team issues, seeking guidance as needed.● Maintains strong working knowledge of protocols and Monitoring Plans for assigned projects.● Perform site selection, initiation, monitoring and close-out visits in… Show more ● Independently resolved protocol questions with the Project Manager (PM) and patient-related issues with the Medical Monitor (MM).● Routinely anticipates/identifies potential issues and implements corrective actions independently. ● Kept project leadership apprised of team issues, seeking guidance as needed.● Maintains strong working knowledge of protocols and Monitoring Plans for assigned projects.● Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. ● Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. ● Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.● Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.● Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.● Facilitate Investigator site identification process and perform site evaluation visits to ensure that investigational sites are suitable and capable of conducting the prospective study.● Facilitate site start up activities including budget negotiation, contract development and negotiations, site initiation visits and GCP instruction to Investigators/Research Personnel.● Perform Trip Report review, management, resolution and escalation.● Conduct project co-monitoring visits and team training.● Serve as site contact for protocol clarifications and subject enrollment.● Manage Protocol Deviation documentation, tracking, and escalation.● Relate project status and issues to Project Manager.● Attends and participates in team teleconferences/meetings providing mentoring and training. Show less