Clinical Research Manager ER Trauma (NIH)
Grady Hospital ER
12.2012 - 03.2015
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team
- Prepared and maintained regulatory documents for clinical trial submissions
- Developed strong relationships with investigators and site personnel to ensure ongoing compliance with study requirements.
- Established drug trial methodologies and procedures to support business and clinical trial endeavors
- Developed strong relationships with investigators and site personnel to ensure ongoing compliance with study requirements
- Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations
- Submitted routine reports and follow-up letters to facilitate internal and external communication
- Collaborated with cross-functional teams to successfully meet project timelines and deliverables
- Provided clinicians with data to conduct clinical trials and determine methods to prevent, screen for, diagnose and treat disease
- Followed informed consent processes and maintained records
- Maintained comprehensive knowledge of applicable regulations and guidelines, ensuring full compliance throughout all stages of clinical trials
- Maintained awareness of industry trends by attending conferences and participating in relevant professional development opportunities
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion
- Reviewed referral information and kept track of intakes from various referral sources
- Oversaw project developments to provide quality deliverables while maintaining optimal efficiency
- Supported successful completion of clinical trials by proactively managing risks and addressing challenges throughout all stages of study process
- Collected data and followed research protocols, operations manuals, and case report form requirements
- Conducted clinical trial in accordance with protocol and recorded and monitored progress
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related outstanding data inquiries
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality
- Gathered and organized clinical trial documentation to meet rigorous standards for site approval
- Leveraged knowledge, expertise and problem-solving techniques to resolve investigative site issues
- Scheduled outside of state 40% of time to meet with Clinical Investigator and staff for updates, training and working management reports
- Interfaced with clinical investigators and site staff to foster ethical research consistent with research plans
- Assessed safety reporting requirements for each study, ensuring proper documentation and notification procedures were followed consistently
- Supported successful completion of clinical trials by proactively managing risks and addressing challenges throughout all stages of study process
- Maintained accurate and up-to-date case report forms and source documents for traceability
- Ensured protocol adherence, conducting regular site visits and providing training to study staff as needed
- Liaised with Clinical Coordinator personnel to communicate important clinical data and in house training and events
