CRA Duties and Responsibilities Include:• Manages small projects under the direction of a Project Manager/Management as assigned• Interact with internal work groups to evaluate needs, resources, and timelines.• Trained to monitor investigational treatment using cytotoxic, targeted, viral, biologic, vaccine and immunologic anti-cancer agents in solid tumor malignancies • Trained to monitor investigational hematology treatment • Performs Site Initiation Visits, Routine Monitoring Visits, and Close Out Visits for industry-sponsored clinical trials• Responsible for all aspects of site management as described in the study plans• Serve as a lead monitor for a protocol or project as assigned• Initial review of study start-up materials: SOPs, draft CRFs, completion manual, compliance forms, study prompters/calendars• Conducts training visits• Participates as a presenter for training classes• Serves as a liaison between study Monitors investigational drug studies in Phases I, II, III, IIIB, and IV.

CRA Duties and Responsibilities Include:• Responsible for monitoring all stages of clinical trials from Pre-Study to Close Out, ensuring compliance with protocol requirements, guidelines set forth by the FDA and ICH, Good Clinical Practice, and respective Standard Operating Procedures and Work Instructions. • Responsible for Site Management and Performance, and documenting as needed the tracking of subject enrollment and site performance. • Proactively identify site issues and work with site staff to provide prompt resolution to any resulting queries. Ensure accurate, complete and timely submission of study related data and sponsor deliverables. • Perform 100 % source document verification, retrieve Case Report Forms (CRFs), performs query resolution in a timely manner and oversee drug accountability and safety at investigative sites. • Ensure Serious Adverse Event (SAE) reporting according to project specifications as well as in accordance to ICH guidelines. • Mentor junior level CRAs and serves as a resource for new employees. Serve as Visit Leader for new CRA training and observation.

• Review and approve monitoring reports ensuring finalization within contractual obligations• Assist Study Managers/Project Managers in study execution by acting as Lead CRA on projects and facilitating communication with Clinical Monitoring team• Perform monitoring evaluation visits with CRAs• Develop and facilitate training for colleagues on clinical, regulatory, administrative and company procedures and processes• Develop study specific tools for tracking and reporting for Clinical Monitoring team• Develop and write Clinical Monitoring Plans • Support project management with assessment of workloads and site assessments within Clinical Monitoring team• Participate and/or present as Bid Defense meetings• Train and mentor junior CRAs and assess ongoing training needs

• Responsible for Site Management and Performance, and documenting as needed the tracking of subject enrollment and site performance. • Proactively identify site issues and work with site staff to provide prompt resolution to any resulting queries. Ensure accurate, complete and timely submission of study related data and sponsor deliverables. • Participate in training of team staff as necessary to ensure consistent monitoring across team.• Responsible for effective communication with site staff, sponsor staff and internal team, ensuring all issues are escalated in accordance to Study Communication and Monitoring Plans.• Coordinate team conference calls and act as liaison between monitoring team and Sponsor Project Management Team.• Ensures monitoring team meets deliverables set forth by INC and Sponsor Project Management. • Responsible for timely review of Monitoring Reports and ensuring related issues are escalated appropriately to the Sponsor. • Provide sign-off of junior monitoring staff for various types of monitoring visits and therapeutic training experience.

CRA Responsibilities:• Implement and monitor clinical trials to ensure sponsor and investigator obligations were met and ensure compliance with applicable local regulatory requirements and ICH guidelines. • Visit sites to assess the qualification of potential investigative sites, initiate studies, instruct site personnel on the proper conduct of studies, to review data and ensure accuracy of data collected and to terminate studies. • Provide regular clinical status information to team members and project management. Work closely with team members to ensure timely resolution of project and/or clinical issues and ensuring proper escalation of applicable issues to upper management as necessary. • Perform investigative site file reconciliation; requests any new or updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project SOPs, and sponsor requirements. • Perform 100 % source document verification, retrieve Case Report Forms (CRFs), performs query resolution in a timely manner and oversee drug accountability and safety at investigative sites. • Ensure Serious Adverse Event (SAE) reporting according to project specifications as well as in accordance to ICH guidelines.

•Identified potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.•Act as team lead by mentoring new project team members•Create project tools to be utilized by team to capture information during all phases of monitoring•Conduct Clinical Staff training and Monitor training at Investigator Meetings•Contributor and active participant in presentations made at Investigator Meeting•Acts as resource for site, sponsor and internal project team members for all aspects of the clinical trial due to extensive experience with Investigational Product, established client relationship since 2004 and internal corporate experience since 2001•Train internal team members and clinical site staff on ICH GCP and FDA guidelines as applicable to current trial•Train team members on effective usage of Siebel Clinical System for data capture and detailed monitoring reports in an expeditious manner•Train internal team members and clinical site staff on Electronic Data Capture system •Conducted site visits to determine protocol and regulatory compliance•Documented all observations during these visits in monitoring reports to our client and via written communication with investigative sites•Verified accurate source documentation and validate case report form entries•Assure prompt thorough query resolution on a ongoing basis•Assessed investigational product accountability through physical inventory and records review•Reviewed regulatory documents and maintain required files at the investigative site and in-house•Assisted in preparation of project publications/tools and sharing ideas/suggestions with team members

•Coordinated training plan for In-House Clinical Research Associate I candidates•Provided direct supervision of candidates in the program assuring that all training goals were met during their tenure in the In-House CRA program•Acted as a mentor for the candidates and made them aware of changes internally and externally within our industry•Identified and interviewed new candidates for the In-House CRA program•Taught training courses as designed for In House Clinical Research Associate program, as well as designed related training and course materials•Interacted with various working groups within corporate structure to ensure In-House candidates were given opportunity to have a working knowledge of their respective functions and practical applications as they apply to the monitoring position•Orchestrated training visits so that In-House candidates would have a practical knowledge and experience to draw upon•Maintained tracking data to coordinate and accurately show training progress for all In-House CRA I candidates and report said metrics to upper management•Conduct unblinded drug accountability visits

•Coordinated the non-clinical/clinical aspects of projects with management teams from different functional groups within corporation and with clients•Provided regulatory document technical expertise to several clinical research trials within the Oncology division. •Responsible for the supervision of assigned clinical administration personnel with as many as 10-19 direct reports at any given time•Responsible for Interviewing and hiring of Clinical Administration Positions, as well as related disciplinary and termination of Clinical Administration staff•Allocated personnel hours and the coordinate clinical research management responsibilities in accordance with expectations set forth by corporate directives •Responsible for analyzing monthly research management costs, personnel hours, and project needs to ensure the most cost effective means of project execution while maintaining high quality standards •Project Clinical Administration personnel work hours for the duration of each trial within the internal Lawson based finance system•Responsible for study set-up and budget set-up within our Siebel Clinical system•Conducted monthly meetings for the Clinical Administration group•Conducted presentations for various face to face meetings with clients related to the clinical administration role on a project team •Conducted training and presentations at Investigator Meetings on Clinical Administration responsibilities of study trials•Conducted On Site Regulatory Reconciliation visits on quarterly basis for assigned trials for which this was contracted•Conducted Regulatory compliance audits, both internal and external as needed or requested by upper management or study sponsor