• Perform site qualification, site initiation, interim monitoring, and close-out visits (onsite or remotely) ensuring regulatory and protocol compliance • Review completion of proper informed consent procedures• Ensure accurate data reporting via review of site source documents and medical records• Interpret data to identify protocol deviations and risks to subject safety/data integrity• Generate queries and manage resolutions with site personnel• Perform investigational product accountability as per the protocol and Study Monitoring Plan• Evaluate execution of study protocol at the site level by using judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicate/escalate serious issues to the project team• Obtain, review, and process essential regulatory and administrative documents as well as conduct audits of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance• Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documents as per SOPs and Study Monitoring Plan• Understand project scope, budgets, and timelines; manage site-level activities/communication to ensure project objectives, deliverables and timelines are met by being able to quickly adapt to changing variables to achieve goals/targets. • Act as primary liaison with study site personnel• Participate in the identification and selection of investigators and clinical sites• Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes in addition to completing assigned training• Utilize knowledge and experience to suggest improvements and/or innovations to pursue on-going systems improvements• Provide mentoring/training to less experienced staff (may perform Monitoring Evaluation or Quality Assessment Visits)

• Perform site qualification, site initiation, interim monitoring, and close-out visits (onsite or remotely) ensuring regulatory and protocol compliance • Review completion of proper informed consent procedures• Ensure accurate data reporting via review of site source documents and medical records• Interpret data to identify protocol deviations and risks to subject safety/data integrity• Generate queries and manage resolutions with site personnel• Perform investigational product accountability as per the protocol and Study Monitoring Plan• Evaluate execution of study protocol at the site level by using judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicate/escalate serious issues to the project team• Obtain, review, and process essential regulatory and administrative documents as well as conduct audits of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance• Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documents as per SOPs and Study Monitoring Plan• Understand project scope, budgets, and timelines; manage site-level activities/communication to ensure project objectives, deliverables and timelines are met by being able to quickly adapt to changing variables to achieve goals/targets. • Act as primary liaison with study site personnel• Participate in the identification and selection of investigators and clinical sites• Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes in addition to completing assigned training• Utilize knowledge and experience to suggest improvements and/or innovations to pursue on-going systems improvements• Provide mentoring/training to less experienced staff (may perform Monitoring Evaluation or Quality Assessment Visits)

• Monitored clinical trials• Acted in a lead role on studies assuming additional responsibilities• Participated in training and monitoring new staff• Participated in data listing reviews• Identified investigators, helped in preparation of regulatory submissions, designed patient information sheets and consent forms, ensured timely submission of protocol/consent documents/safety reports for IRB approval• Pre-study/placement and initiation visits, conducted regular monitoring visits in accordance with ICON/sponsor SOPs • Communicated with clinical research investigators• Knowledge of good clinical practice and local regulations• Ensured accurate archiving of files at study completion and maintain patient and sponsor confidentiality

• Monitored clinical trials• Worked directly with the sponsor company through CRO• Ensured compliance with the clinical trial protocol• Checked clinical site activities• Made on-site visits• Reviewed Case Report Forms (CRFs) • Communicated with clinical research investigators• Knowledge of good clinical practice and local regulations• Assisted study teams and hospital staff in overall conduct of study protocols and training for accurate and quality drug development

• Provided general administrative support to the Clinical Operations Department and assistance to Project Managers and Project Directors• Assisted the Clinical Operations teams in completion of all required tasks to meet departmental and project goals• Supported Clinical Operations teams with ongoing conduct of studies• Familiar with ICH GCP, regulations, SOPs, and internal tracking systems• Familiar with the role of the Clinical Research Associate (CRA) including site visits processes• Assisted project teams with study specific documentation and guidelines• Set up, organized, and maintained clinical study documentation (Trial Master File [TMF], CRFs, ESF, Investigator Files, etc.) including preparation for internal/external audits, final reconciliation, and archival• Processed Data Collection Forms (i.e., log in, tracking, quality control)• Assisted in quality control audits of clinical study documentation• Coordinated ordering/dispatch and tracking of trial materials• Assisted project team with trial progress tracking by updating the Clinical Trial Management systems• Copied and routed incoming correspondence, internal documentation, CRFs, etc.• Contacted sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, clarification of documentation, etc.)• Assisted in tracking and distribution of safety reports• Coordinated document translation• Attended project team meetings and generate meeting minutes• Assisted the Project Manager and project team with Investigator Meeting/Rejuvenation Meeting coordination, activities preparation, and generate meeting minutes• Assisted in production of presentation materials• Assisted in the coordination of team member tracking

• Co-Chaired Evaluative Study on Retention Committee• Designed, developed, implemented, and maintained quantifiable Program Evaluation process that objectively measures and authenticates effectiveness of service delivery to participants in accordance with Safer’s standards and contractual requirements• Performed monthly file audits and regular comprehensive audits of the Sheridan program and other programs within the Safer Foundation• Provided assistance with updating quality improvement activities within the organization• Performed data entry, statistical analyses, and report writing associated with the various phases of the evaluation and to improve policies and procedures• Worked with outside vendor to create customized reports from the proprietary database system• Developed and implemented strategies for collecting outcome data to describe program success or nonsuccess through items such as employment, educational attendance, financial stability, etc.• Conducted ongoing analysis of the effectiveness of the use of incentives as it relates to retention rates• Accurately compiled and submitted reports to the Program Director and other appropriate individuals within agreed upon time frames• Acted as liaison with IDOC representatives• Trained new employees on the proprietary database system and the creation of Standard Operating Procedures

• Consented Naval Recruits into a Phase III clinical study• Followed-up with Recruits to determine if they present any medical symptomology• Stuffed Recruit medical charts• Maintained client records• Ad hoc tasks as requested by Lead Coordinator or designee

• Oversaw all IRB paperwork for the Center’s multiple research projects• Prepared various grant proposals including creating literature reviews, collecting/analyzing statistical data information, gathering supportive documentation, and formatting/editing• Oversaw all marketing research for The EPEC Project• Organized and maintained The EPEC Project’s multiple databases for marketing, follow-up information, and analyses purposes• Worked on multiple faculty members’ research projects• Researched, wrote, and published literature reviews• Designed and implemented surveys• Recruited, coordinated, and processed participants• Developed and maintained multiple databases• Co-authored publications and reports to stakeholders