Clinical Operations Manager
Resume:
ERICA D. BROWN
**** ****** ***, ******** **, ****3
*****.*.*****.***@*****.***
QUALIFICATIONS SUMMARY
Passionate and dedicated professional with solid experience in neuropsychology, clinical and non- clinical research, clinical auditing, FDA audit preparation, budgets, financial analyses, marketing, mentoring, and administrative/business operation supports. Related skills, practicum, and experience include:
Clinical Support: Trains university research staff on new health technology and data management. Supervise and trains new coordinators and research technicians in research protocol implementation. Ability to successfully initiate and implement resource-planning strategies to improve and enhance project productivity. Coordinated with business managers to determine budget needs during negotiations, study fund management, invoicing, departmental allocations and supplies dispensed. Extensive experience in the areas of neuropsychological evaluation, psychosocial interviews, obtaining informed consents, statistical analysis, research protocol and IRB submissions, adhering to DOD, GCP, GLP, GMP, GxP, ICH, NIC, FDA and IACUC guidelines and protocols designs, edits and submits grant proposals and budgets, correspondence with federal regulatory entities, and data maintenance. Proficient in statistical tools such as SPSS, R-studio, JMP; neuro-imaging software, UNIX environments, SPM, Microsoft Office Package, EPIC, Visio Pro, OnCore Clinical Research Data Management System, RAVE, Medidata, eTMF/TMF Management, Veeva Vault, Siebel CTMS, Velos CTMS, REDCap, and Adobe.
Communication: Outstanding use of oral communication skills and writing conventions appropriate to purpose and context. Effective interpersonal skills facilitated by active and accurate listening. Outstanding adaptability of communication style to accommodate diverse professionals. Proficiently collaborates with others to complete projects within strict timeframes.
Achievements/Strengths: Capacity to understand and integrate new technological methods quickly and fluidly. Strong communication and group dynamics skills exercised to work productively as a member of a team. Successfully supervise research technicians and junior coordinators, setting research and professional goals. Effectively plan and execute projects independently with minimal supervision. Results driven, thrives on challenges that require advanced problem-solving skills and attention to detail. Ethically and responsibly manage and use information and technology.
EDUCATION & CREDENTIALS
o DBA Candidate- Haub School of Business: 2027 SAINT JOSEPH'S UNIVERSITY, Philadelphia, Pennsylvania
o MBA- Pharmaceutical and Healthcare Marketing: 2023 SAINT JOSEPH'S UNIVERSITY, Philadelphia, Pennsylvania
o Bachelor of Science Degree in Psychology & Neuroscience: 2005 UNIVERSITY OF PITTSBURGH, Pittsburgh, Pennsylvania
o CPR, AED, and Basic First Aid Certification: Adult, Child and Infant. Exp. 11/9/2027
o D. Gur, J.H. Sumkin, M.L. Zuley, A.H. Klym, E.D. Brown, D. Lederman. The Baseline Mammogram: Are we doing enough to reduce recall rates? Presented at RSNA 2011, Chicago, IL
o Zheng B, Tublin M, Lederman D, Klym A, Brown E, Gur D, Classification of thyroid nodules using a resonance-frequency based electrical impedance spectroscopy: progress assessment, Proc SPIE 8218-51. o Research Assistant (volunteer) April 2008 - June 2012: Hippocampus extraction, slicing, and culture to create natural cellular signals. Practiced GLP, adhered to IACUC guidelines, aseptic technique, IF and IHC staining procedures.
Immunofluorescence and Immunohistochemistry double staining to identify GAD interneurons and CAMKII receptors in areas CA1and CA3: UNIVERSITY OF PITTSBURGH, Pittsburgh, PA
PROFESSIONAL EXPERIENCE
Coalition of Cancer Cooperative Groups: Clinical Operations, Philadelphia, PA Clinical Team Manager (June 2023 - present)
• Reporting to the Senior Director, responsible for managing senior clinical project managers, associate project managers, contract monitors, and clinical research associates. Trains all internal staff and traveling clinical monitors on GCP, drug accountability, effort and budget allocations to maintain fiscally positive studies, eTMF and TMF maintenance, vendor management and audit readiness.
• Conducts Clinical Operations oversight meetings to ensure cross functional alignment of activities. Increased meeting frequency is determined based on clinical priorities, new studies, and staffing
• Completes 1:1 bi-weekly meetings with 15 direct reports to determine progress, professional development, and learn the interest of the staff. Conducts performance evaluations, creates performance and mitigation plans as needed, and moderates meetings and processes when reportable events occur
• Introduced a new budgeting framework that optimized resource allocation, saving $2 million over the life of a study due to reduction of rework, effective effort tracking and increased staff retention.
• Implemented a Clinical Project Management training program based on a detailed gap assessment and analysis, audit findings, and identified rework/overburn in budget hours
• Manages the new hire orientation process including record retention and reconciliation prior to requalification audits or reviews by potential new clients
• Coordinates the development of project teams including members of the Medical, Data Management, Regulatory, Monitoring and Clinical Supplies departments as needed
• Collaborates with Finance to develop study proposal costings, budgets, and FTE for assigned staff
• Authorizes and tracks PTO for the research teams
• Reviews and approval of all billable hours, travel, and expenses for the research teams
• Oversee the site reimbursement process for the research teams
• Reviews resource assignment and effort allocation. Adjusts as required based on study needs, workloads, and turn over
• Acts as liaison for department as it relates to potential HR related issues and concerns
• Coordinates communication with and within all departments regarding the delegation of study tasks and team(s)
• Serves as back up for PMs during leave if necessary
• Coordinates departmental communication regarding the delegation of study tasks and teams(s)
• Attends relevant meetings for sponsor-related activities, cooperative groups and the organization’s staff meetings
• Assists with CAPA and training related to research compliance, quality control, and quality assurance.
IQVIA Biotech: Oncology, USA, Remote
Clinical Trial Manager- Contract (January 2023 – June 2023)
• Worked with Project Manager (PM) to define program targets for clinical monitoring staff and assured work is documented within contracted project scope. Communicated and documented all interactions with client as required by SOP.
• Serve as client advocate within IQVIA Biotech.
• Developed and implemented Clinical Monitoring Plan.
• Team Duties/Responsibilities:
• Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes, including:
• Coordinated site management activities.
• Site identification, recruitment, and selection.
• Regulatory document collection and review.
• Overall scheduling and management of all site visits.
• Developed site/monitoring tools and training materials.
• Reviewed and identified trends in enrollment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions.
• Coordinated and oversaw daily operations of clinical monitoring team:
• Set and enforced project timelines with the assigned study team.
• Coordinated remote review of clinical data within EDC system.
• Oversaw monitoring visit schedule to ensure compliance with frequency set forth in contract.
• Reviewed and approved trip reports and follow-up letters within required timeframe.
• Scheduled and managed weekly CRA project team meetings.
• Ensured CRAs assigned to team receive therapeutic and project-specific training.
• Managed quality and regulatory compliance among clinical monitoring team and investigational sites.
• Managed project milestones and proactively addressed deficiencies:
• Attended and provided information at monthly projections meetings.
• Attended and provided information at weekly client teleconferences/team meetings.
• Assisted Project Manager in identifying Out of Scope activities and assuring that such activities do not begin until the client provides authorization.
• Managed CRA performance:
• Defined and implemented functional standards, goals, and expectations with clinical monitoring team.
• Served as CRA mentor and perform accompanied field assessment visits as required.
• Participated in the performance appraisal program by providing timely and accurate feedback regarding the performance of each respective CRA.
• Documentation Duties/Responsibilities:
• Assured that the appropriate IQVIA Biotech and/or sponsor SOPs are followed.
• Ensured all project documentation is appropriately filed per IQVIA Biotech SOPs .
• Assisted PM in preparation of audit responses, as appropriate.
• Assisted PM with preparation of information for inclusion in monthly report to client.
• Budget/Contract Duties/Responsibilities:
• Presented/participated in the bid defense for study requiring budget adjustment. o Assisted PM in reviewing project budgets, monitoring costs, potential overruns and proposed/implemented cost effective solutions.
• Defined the scope of work with the client and clinical monitoring team.
• Assisted PM in identifying and generating changes in scope and notify client of potential changes in scope.
• Reviewed and approved CRA travel expenses and time sheets. University of Pennsylvania School of Medicine: Department of Compliance and Monitoring, Philadelphia, PA
Senior Clinical Research Monitoring Specialist/Clinical Team Manager (October 2017 – December 2022)
• Reporting to the Director, Abramson Cancer Center Department of Operations, Compliance and Monitoring (DOCM), responsible for scheduling, coordinating and conducting monitoring and/or auditing of all oncology studies being conducted within the Abramson Cancer Center. 5 to 8 audits per month of IIT, multi-site (including international trials with 55+ sites)
• Perform quality monitoring/auditing of studies of special interest (to the DSMC) and high- risk oncology clinical research trials.
• Independently assess pharmacy support and conduct.
• Assists with CAPA and training related to research compliance, quality control and quality assurance.
• Re-train study team members and investigators on compliance, quality control, quality assurance, subject safety, and GCP.
• Enhanced Auditing of rare disease oncology trials in preparation for the external audits and treatment approvals. Participates in NCTN, FDA, and Theradex external audits.
• Assist the CCO-CR with data and reporting needs for the NCI Cancer Center Support Grant. Updating NCI-CTRP with site accrual, reportable data verification and site participation.
Thomas Jefferson University: Jefferson Clinical Research Institute, Philadelphia, PA Project Specialist (June 2015 – October 2017)
• Project Manager for the implementation of the new patient remuneration process using Greenphire’s ClinCard technology, while improving current remuneration processes. o Conducts weekly webinar trainings for the research community including Research Coordinators, Financial Administrators, and Directors across the University. o Organizes and leads bi-weekly meetings with high level KOLs within the university and hospital system
o Develops small, focused, work groups with assigned tasks to design the detailed process for each level of remuneration.
o Develops SOPs for payment process, remuneration budget negotiations, access to the system, universal consent language, payment approvals, and card distribution. Central liaison between Greenphire and TJU.
o Organizes IDT and RFP process at the departmental level.
• Supports the University’s research community as the CTMS Project Manager conducting monthly OnCore trainings with Research Coordinators, Clinical Managers, and Business Operations teams at all affiliate sites. Presents bi-monthly at Jefferson Clinical Research Forums
• Member of the EPIC implementation and S.U.P.E.R User training team; interfacing OnCore with Epic to streamline patient research billing. Assists with the design of JCRI’s website.
• Develops clinical trial calendars used for patient visits, budget and MCA development, research invoicing, patient tracking and CRO reporting.
• Provides OnCore access and role management to the University staff. OnCore is the clinical research data management system required for all IRB submissions and maintenance of all aspects of clinical trials.
• Resolves data management and Health IT tickets for all TJU and TJH users. University of Pennsylvania School of Medicine: Department of GI Research, Philadelphia, PA Clinical Research Project Manager (October 2013 – July 2014)
• Supervised a team of five coordinators. As a unit we supported the implementation and maintenance of clinical trials for pharmaceutical companies, and investigator-initiated studies that examine the efficacy of new drugs for the treatment HCV and the prevention of HCC post liver transplant. Delegated tasks to each direct report and held weekly supervision meetings to discuss progress, growth potential and issues.
• Completed and submitted regulatory documents including, but not limited to, protocol development and review, finishing progress reports, assisting with grant submissions, manuscript editing and submitting, IRB submissions, COI reporting, IND reporting, FDA correspondence, and reporting of SAEs, SIVs, and COVs for local and multi-site trails
(managing 12 sites). Ensures all associated research protocols are prepared for external audits and monitoring visits and protocols are executed in accordance with GCP and ICH federal guidelines
• Recruited, consented and tracked patients participating in multi-site clinical trials with extended follow-up visits. Monitored patient recruitment statistics and outcomes. Performed complete Q&A data checks for each coordinated study.
• Constructed, maintained and analyzed databases involving all individuals transplanted with cancer within the department of liver transplant. Provided summary statistics for physician presentations and publications.
o Oversaw and maintained confidential, sensitive information as outlined by the IRB’s Human Subjects Control policies not accessible by the researchers o Completed University of Pennsylvania’s Clinical Research Coordinator and Supervisory certifications with training in EPIC, REDCap, Med View, OTTR with experience in clinical interviews. Analyzed research data using STATA. University of Pennsylvania School of Medicine Treatment Research Center: Department of Psychiatry and Addictions, Philadelphia, PA
Clinical Research Coordinator C (July 2012- October 2013)
• Supported the implementation and maintenance of single site and multi-site clinical trials for pharmaceutical companies, NIAAA, and investigator-initiated studies that examine the efficacy of new drugs for the treatment of populations with various addictions.
• Performed complete Q&A data checks for each supervised study. Conducted internal monitoring of other research sites and internal studies as well as study start up and close- out procedures, site initiation visits, generated queries for Coordinators to rectify prior to external/sponsor monitoring visits. Performed statistical analyses on requested research data submitted with PI publications, assisted with grant submissions, protocol development and review, manuscript editing and submitting.
• Supervised research technicians, conducted weekly supervision meetings to discuss study progress, performance, goals, and outside opportunities for the technician’s development. Back-up to the Project Manager when required: conducted supervision meetings with research coordinators, managed external site queries from research sponsors, managed all day to day tasks for the treatment center.
• Coordinated weekly meetings and monthly seminars regarding research progress within the division, recruitment progress and future endeavors for the committee, and the implementation of improved research procedures for the staff.
• Completed and submitted regulatory documents including, but not limited to, finishing progress reports, grant submissions, manuscript edits, IRB submissions, IND reporting, FDA correspondence, and reporting of AEs and SAEs. Ensured all associated research protocols are prepared for external audits and monitoring visits ensuring all protocols were executed in accordance with GCP and ICH federal guidelines.
• Aided as the back-up for the petty cash coordinator when needed
• Monitored patient recruitment statistics and medical charts, and aiding as a study back-up for technicians when necessary (Processes and stores UDS and blood samples of potential participants, conducts required assessments relative to specific studies)
• Interviewed and trained new research technicians as well as providing ongoing training for existing technicians. Implemented professional development Q&A sessions for research technicians.
o Research focus is toward opiate, cocaine and alcohol addiction treatment utilizing Cognitive Behavioral Therapy, testing the feasibility of using Skype for participant visits. Non-treatment behavioral studies examine participant’s cravings for illicit drugs after tempting cues are presented. Oversees maintains confidential, sensitive information as outlined by the IRB’s Human Subjects Control policies not accessible by the researchers
o Assisted in the recruitment and retention of research participants using phone screens, brochures, flyers, and administers follow-up calls and surveys o Completed University of Pennsylvania’s Clinical Research Coordinator and Supervisory certifications with training in ASI, TLFB, CGI, COWS, VAS assessments and clinical interviews.
University of Pittsburgh School of Medicine: Department of Radiology Research Imaging, Pittsburgh, PA
Research Specialist (June 2008 - June 2012)
• Provided direct research support to the Senior Principal Investigator, radiologists and technologists, in the clinical imaging facilities with the execution of specific methodology. Research focused on using new tomography (Hologic), and cone beam technology to approve mammogram imaging. Served as “honest broker” of the research projects.
• Maintained IRB submissions, regulatory documents, and participated in monthly budget meetings.
• Participated in the preparation and set up of pilot studies necessary for the development of finalized protocols for complex observer performance studies. Coordinated activities for 2 multi-site trials and longitudinal studies for breast imaging analysis. Supervised and trained research personnel on protocol execution and paradigms.
• Collaborated with faculty researchers and the division director in the development of research protocols, manuscript abstracts and data analyses. Developed and accurately maintained confidential databases as outlined by the IRB’s Human Subjects Control policies not accessible by the researchers.
• Assisted with editing and formatting of grants and national presentations. Interviewed and supervised interns and work study students. Set performance goals to enhance the student’s repertoire, required presentations at the end of the term on research conducted. Provided recommendations for employment, graduate and medical school applications. o Co-Author of “The Baseline Mammogram: Are We Doing Enough to Reduce Recall Rates”, presented as a scientific paper at RSNA 2011. o Zheng B, Tublin M, Lederman D, Klym A, Brown E, Gur D, Classification of thyroid nodules using a resonance-frequency based electrical impedance spectroscopy: progress assessment, Proc SPIE 8218-51. o Played a key role in tracking, obtaining, and de-identifying imaging examination cases across various UPMC platforms
o Managed 5 clinical sites locally and conducted SIV, monitoring and COV of 11 distant sites
o Maintained organized confidential databases for patient follow-up and tracking diagnostic “truths”. Created new QA tools to ensure database accuracy using Microsoft Access.
o Summarized and performs analyses of experimental data using ROC, SPSS, and SAS.
ADDITIONAL SKILLS
MBA & Pharmacy Technician
Pharmaceutical R&D Mapping: Expertly mapped the pharmaceutical R&D process from target identification to commercialization, identifying activities, risks, and distinguishing processes for medical devices and diagnostic products. Cost Analysis & Milestones: Predicted and analyzed major cost drivers, key decision points, and critical milestones in the R&D process to optimize resource allocation. Social Impact Evaluation: Assessed the social impact of pharmaceutical drug development, clinical research, direct-to-consumer (DTC) advertising, and executed corporate social responsibility (CSR) initiatives.
Strategic HR Integration: Integrated human resource management with overall business strategy to achieve competitive advantage through attracting, developing, and retaining a highly effective workforce; focused on leadership and team dynamics. ROI Maximization: Critiqued portfolios, development plans, and organizational changes in pharmaceutical R&D companies to maximize return on investment (ROI). Pharmaceutical Marketing Strategy: Researched pharmaceutical ethics guidelines and advertising provisions; developed marketing plans for new drugs; designed marketing research studies addressing current market mixes and new opportunities; incorporated global, economic, clinical, ethical, political, social, legal, regulatory, environmental, and diversity factors into strategic decision-making.
Financial Management & Accounting: Applied managerial accounting, invoicing, financial management, and budgeting skills to conduct corporate financial analyses; determined viability of new products, assessed company stability, and performed cost-benefit analyses of pipeline and market products; evaluated business unit performance and modeled strategic alternatives within ethical frameworks and generally accepted accounting principles
(GAAP).
Cost & Profit Analysis: Computed breakeven analysis, sensitivity analysis, and contribution margins; interpreted cost-volume-profit (CVP) graphs; understood cost types, behaviors, and estimations; utilized cost data for informed decision-making; compiled capital, operating, cash, cost, and sales budgets.
Financial Reporting & Analysis: Prepared balance sheets, income statements, and statements of cash flows; read and interpreted financial statements of public companies; performed comparative financial analyses of large pharmaceutical companies; made critical business decisions using management accounting data.
Ethical Framework Application: Built ethical arguments based on defensible constructs; assessed and applied ethical considerations to pricing, healthcare allocation, product promotion, advertising, and profit strategies in pharmaceutical and healthcare sectors. Optimized Pharmaceutical Care: Performed pharmacy functions, including accurately filling and processing prescriptions in compliance with department protocols, ensuring optimal patient care.
Regulatory Compliance: Maintained precise records of drug shipments and managed ordering and proper storage of controlled substances in accordance with DEA policies. Advanced Information Management: Managed sensitive data using an advanced electronic pharmacy management system, ensuring confidentiality and accuracy. Patient and Provider Liaison: Acted as a critical link between patients, physicians, and insurance companies to ensure satisfaction and compliance; conducted extensive research to resolve concerns and enhance patient care.
VOLUNTEER & MENTORING EXPERIENCE
YMCAs of Delaware & Edge Fitness, DE/NJ/PA – (2013-present) Certified Instructor: Formats - Spin, Les Mills Pilates, Les Mills GRIT, Rhythm Ride Regional Rhythm Ride Trainer and Format Auditor
o Cultivates an inspirational workout community built on effort and camaraderie, in a safe space for self-expression
o Trains fitness instructors on Rhythm Ride format and methods to increase rider participation and retention
Boys and Girls Club - Bear, DE
Certified Bokwa Instructor L1-L3 (2013-present)
• Instructor of a new group exercise class built around the combination of boxing and a South African musical style titled Kwaito.
o Leads a group of 20 or more youth in an hour exercise class using universal sign language and Bokwa hand signals to identify letters, numbers and movements for each workout set
o Generate a playlist that is appropriate for a wide age range of participants o Closes each class with nutritional tips for healthy living o Member of the Bokwa Fit team.
University of Pittsburgh Anointed Steps of Faith Campus Ministry, Pittsburgh, PA Executive Board Step Master (2001-2005); Graduate Chair (2005-2008); University Advisor
(2008-2012)
• Acted as the liaison between the ministry and the university. Provided advice and insight to constitutional changes, ministry fundraising, development and implementation of annual showcases in collaboration with other universities in the area and church ministries throughout the city of Pittsburgh.
o Set up weekly advising/mentoring sessions with members of the ministry to discuss current or future endeavors.
o Set up weekly study sessions and meetings to discuss major fields of study, class schedules, and career counseling. Submitted numerous letters of recommendation and endorsements on my behalf of my mentees for graduate and professional programs.
o Supervised weekly executive board meetings to ensure the ministry followed proper protocol and procedures, while making everyone feel comfortable within the step ministry.
o Assisted in keeping a diverse, enjoyable, encouraging environment where all members can freely express themselves with love.
o Organized community clean-up sessions in neglected neighborhoods around Pittsburgh. Fostered a relationship between the ministry and The Pittsburgh Family House, The Ronald McDonald House of Pittsburgh as well as local high schools to allow the ministry members opportunities to tutor local youth, and provide entertainment and baked goods to the PFH and RMH families.
Mount Ararat Baptist Church, Pittsburgh, PA
Youth Ministry Mentor (2004-2008)
• Coached, mentored, and tutored a ministry comprised of 25 African American young ladies ages 8-18. Developed appropriate and effective showcases of the ministry targeting young Christian women in the Pittsburgh area.
o Organized various volunteer opportunities at local soup kitchens and community clean-up events.
o Implemented monthly health discussions covering, but not limited to, development, hygiene, abstinence/sexual health. Created worksheets and games to encourage active learning and participation.
o Created rubrics for preparing for the next stages in school, i.e. the transition from middle to high school, high school to college, and from college to careers. Set up sessions for SAT prep, essay writing, application prep, interviewing tactics and appropriate attire. Conducted weekly study sessions, each highlighting a subject and topic particularly difficult for each age group within the ministry (subjects included simple to complex IB mathematics, social studies to high school history, and general sciences to IB biology
o Conducted weekly practices that began with bible studies and ended with positive speaking of self. This was created to evoke good self-esteem, individualism, and team building
o Held open forums where the mentees could have open, non-judgmental discussions centered on avoiding being part of the negative stereotypes and becoming well- informed, well-versed, intelligent women
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