I am pursuing a career path focused on the development of an ethical framework for academic and pharmaceutical industry research collaborations. Combining clinical trial expertise gained through my diverse academic background in psychology, oncology/cancer biology and bioethics with my specific interests in medical ethics, quality assurance, regulatory affairs, pharmacovigilance, and health policy, I am interested in examining ways to address and implement rubrics for the growing trend of alliances between academia and the pharmaceutical industry.

GxP Quality Assurance Auditor @ -Auditor & Consultant for internal and external research teams (Principal Investigators, Clinical Research Coordinators, Clinical Research Nurses, Data Managers, Project Managers, Clinical Operations, Quality Assurance, Regulatory Affairs) re: FDA regulations, ICH GCP interpretation and guidance, as well as internal institutional policies for research & clinical quality related recommendations for cancer immunotherapy clinical trials, specifically the groundbreaking research involving chimeric antigen receptor-modified T cells—or CART-19. -Prepare and distribute audit reports summarizing all potentially significant findings for the following types of audits: 1) GCP/PV audits of investigator sites, clinical studies, suppliers, vendors. 2) Document audits: Sponsor and site Trial Master File (TMF), protocol, ICF, SOP, etc. Specific goal of developing an adapted and user-friendly academic model of existing Drug Information Association (DIA) guidelines. 3) Process audits: research specific procedures/processes, internal departmental processes, internal institutional processes. 4) Vendor audits (as necessary): qualification, quality management systems. - Site Initiation Visit (SIV) representative for the Quality Assurance (QA) team for new trials. - Developer and educator of rapidly changing guidance for QA related topics. * Proactive management of GCP noncompliance issue identification, escalation and management of Corrective and Preventive Action (CAPA) plans, from verification through closure. * Lead and participate in FDA pre-inspection preparation, inspection hosting, and post-inspection activities to promote their successful outcome. Extensive previous experience with FDA pre-inspection preparation (N = 12+ inspection preps, no issuance of FDA Form 483). -Development of Quality Systems Management by leading & participating in SOP authorship and review teams. From March 2015 to Present (10 months) Greater Philadelphia AreaClinical QA Auditor @ Starting position 1/5/2016. From December 2015 to Present (1 month) Sr. Monitor & Auditor; Scientific Review Committee Manager; DSMC Manager @ --Senior Monitoring Specialist: 1) Conducted more than 200 GCP & PV audits (routine, for cause, FDA-inspection prep, etc.) 2) Conducted regular monitoring visits for high risk institutional/in-house investigator initiated trials for the following cancer-related clinical trials: NCI Cooperative Group, Pharmaceutical/Biotech, NCI/CTEP funded/supported, institutional/in-house. Areas addressed in audits: regulatory documentation, consent and regulatory procedures, protocol adherence, eligibility criteria, treatment administration & accountability, recording and reporting of adverse events, response assessment, subject follow-up, adherence to IRB policy, overall quality of data, manufacturing (where applicable). --Clinical Trials Scientific Review and Monitoring Committe (CTSRMC) Manager: 1) Managed registration of all new cancer related clinical trials conducted at Penn of the following study types: therapeutic, prevention, supportive care, Screening, Early Detection, Diagnostic, Epidemiologic, Observational, Outcome, Ancillary, Correlative. 2) Registered and process initial submissions of Full Board, Expedited and Exempt reviews. 3) Assigned Primary, Secondary, Biostatistical & Regulatory reviewers to each newly submitted protocol. 4) Compiled reviewers' comments and write formal stipulation letters to Principal Investigators. 5) Drafted initial study review approval letters. 6) Managed responses to studies approved with stipulations or disapproved. --Data Safety and Monitoring Committee (DSMC) Manager: Was responsible for organizing monthly committee meetings to review subject safety issues, coordinate the review, evaluation and approval/disapproval of protocol deviations and exceptions, review of on-site/off-site Adverse Events (AE) and Serious Adverse Events (SAE), assessment and development of SMPs and examination of evaluations conducted by industry site monitors, Medical Monitors and Data and Safety Monitoring Boards (DSMB). From August 2013 to March 2015 (1 year 8 months) Senior Regulatory Compliance Monitor & Auditor @ --Coordinate and conduct GCP and PV audits and regular monitoring visits (high risk studies only) of cancer research studies with a view to quality control and assurance to ensure programmatic compliance with all applicable regulations. --Act as a backup to the Manager of Research Compliance with PV duties. --Responsible for managing submissions of external monitoring reports to the DSMC. --Assist the Director and Manager of Research Compliance with various aspects of CTSRMC and DSMC responsibilities. --Assist in preparation of federal and other external audits. From September 2011 to August 2013 (2 years) Sr. Clinical Research Coordinator/Data Manager - Center for Clinical Epidemiology and Biostatistics @ --Manage/coordinate breast cancer epidemiology studies --Supervise Research Assistant’s work --Evaluate patient eligibility using medical records --Collect study data (questionnaires, serum and tissue collection) from patients and from medical records at time of enrollment and throughout follow up period --Maintain study database --Prepare and follow up for internal regulatory audits --Project manager for ISPY2 - Clinical Trial From February 2007 to September 2011 (4 years 8 months) Clinical Research Coordinator - Abramson Cancer Center & Department of Rehabilitation Medicine @ --Screened medical charts for potentially eligible subjects; recruited these eligible subjects and enrolled them into research protocols. --Participated in conceptualization and formulation of new projects; including protocol development and IRB applications. --Monitored patient accrual, protocol adherence and data quality; coordinated data review; coded data and prepared for data analysis. --Prepared progress reports and audits; identified adverse events. --Interfaced with collaborating investigators on primary research projects to facilitate data collection, management, and responded to data queries. From November 2004 to February 2007 (2 years 4 months) Lead Residential Teacher & Enrichment Supervisor @ --Provided training to new residential teachers in data collection and management, behavioral interventions, house routines, clinical reviews, and goal implementation. --Taught social, living, and recreational skills to children and adults with autism, developmental disabilities, and other neurological disorders. --Analyzed data to chart progress of acquired skills and behaviors, presenting at biweekly clinical reviews. From August 2001 to November 2004 (3 years 4 months) Research Assistant/Subject Coordinator @ --Neuropsychological testing of schizophrenic patients, analyzed data. --Devised and implemented a schedule for testing patients and controls. --Collated data and maintained patient and control records. From September 1998 to August 2000 (2 years)

Master of Bioethics (MBE), Deptartment of Medical Ethics & Health Policy @ University of Pennsylvania School of Medicine From 2010 to 2013 Bachelor of Arts (BA), Psychology Major (honors), Linguistics Minor @ Northwestern University From 1997 to 2001 Luke Velders is skilled in: Clinical Research, Clinical Trials, Research, Data Analysis, IRB, Oncology, Medicine, GCP, Public Health, Regulatory Affairs, Epidemiology, Grant Writing, Statistics, Molecular Biology, Nonprofits