Project Manager/Clinical Research Coordinator

DIANA COOPER-HAVLIK

**** ******** *****

Katy, TX 77494

Cell: 281-***-****

E-Mail: *************@*****.***

PROFESSIONAL SUMMARY

Results-driven professional with experience in data analysis. database management/reporting/presentation, research studies, customer service, staff office management and administrative duties. Consistently successful interactions with leadership and all staff levels while providing excellent customer service and flexibility using highly effective verbal and written communication skills. Strong analytical ability to evaluate workflow systems, identify opportunities for improvement, develop, implement and monitor action plans. Self-directed, independent and organized. Great at multi-tasking and very flexible. Instrumental in problem-solving departmental needs. Adaptable to various automated processes. Maintain functionality of operational system for departments while ensuring ultimate internal/customer satisfaction, accuracy, consistency and integrity in support of performance improvement measures.

TEMP WORK-General 3/11-present

BAYLOR COLLEGE OF MEDICINE 4/10-02/11

Clinical Research Coordinator III

Internal Medicine/Gastroenterolgy & Hepatology

* Managed BRAIN database for departmental protocols.

* Worked on Regulatory documents and submitted protocols to IRB for approval/renewal/amendments with Research doctors.

* Assisted in the applications for grants to NIH in concert with Research doctors.

* Managed budget/finances for drug-sponsored protocols.

* Analyzed project goals, plan deadline schedule for project completion; from inception to completion.

* Prepared and participated in the preparation of reports for research work.

* Acted as liaison between patient and physicians regarding problems, adverse reactions and follow-ups-all patient care matters.

* Registered patients, in charge of patient care plan; including consents, appointments, treatment.

* Contacted all Drug-Sponsored & Investigational New Drug protocols.

* Analyzed and ensured accurate data collection/entry and abstraction for all protocols/patients.

* Worked with various clinical specialists and physicians at every hospital in the Houston Medical Center & private physicians.

* Implemented excellent customer skills daily to relay information, train, meet directors, staff & clients.

* Assisted departmental Administrator with proposals, grants, contracts, budgets for all research studies.

* Advertised for Baylor Clinical IBD Studies in Green Sheet, Baylor Research Website & Baylor Website for students/interns.

* Interacted with patient insurance companies for claims, payments and resolutions.

* Supervised, analyzed and created performance improvement plans.

* ICD-9 experience in database management.

* Insurance verification experience.

* Direct administrative support to faculty; experience with research/academic functions; grant/manuscript submissions.

* Supervised office/clinic staff for 7 physicians.

BAYLOR COLLEGE OF MEDICINE 10/08-8/09

Project Manager, CONFLICT OF INTEREST (COI)

Research Oversight Administration

* Managed BRAIN for COI, ICOI and ECOI.

* Reported Institutional/Individual/Industry Conflict of Interest for the College.

* Used customer skills daily to relay information, train and meet directors and staff.

* Immediately reported Individual Conflict of Interest for the College and Principal Investigators.

* Alerted leadership regarding actual and/or potential conflict of interest for their review.

* Worked with programmers in the formulation of ideas to include COI features, reporting mechanisms and testing.

* Participated in staff training for clinical research and compliance.

* Analyzed and calculated Metrics; including reporting and presentation preparation.

* Instrumental in the re-organization/re-structure of dissolved departments.

* Interviewed potential staff; exit interviews for staff of dissolved departments.

* Supervised staff/office; including interviewing, hiring, terminations, training, performance improvement plans.

* ICD-9 experience in database management.

* Insurance verification experience.

* Direct administrative support to faculty; experience with research/academic functions; grant/manuscript submissions.

BAYLOR COLLEGE OF MEDICINE 11/06-10/08

Project Manager, Clinical Research

Center for Cell & Gene Therapy

* Conducted orientation, training and re-training, if applicable, for new and current research staff.

* Closely managed all aspects of patients and their care while on studies; including medications, study-mandated testing,

possible problems, designed and implemented plans to provide continual patient/study coverage.

* Organized and held meetings to disseminate/discuss new, altered and relevant information to research staff regarding

studies, patient safety, number of new patients, IRB regulation updates, tracking/updating patient data and records.

* Represented staff in relaying information to administrators and physicians; including process improvements.

* Managed projects to ensure implementation in accordance with specified objectives.

* Analyzed project goals, planned deadline schedule for project completion; from inception to completion.

* Developed, recommended and implemented necessary improvements/changes for department.

* Prepared and participated in the preparation of research reports.

* Coordinated day to day activities of clinical research protocols.

* Registered patients, ensured ongoing eligibility, patient safety; including consents, appointments, explanation of treatment

plan and possible adverse events.

* Acted as patient contact/liaison between patients and physicians regarding problems, adverse reactions, weekly checking of

patient wellness and follow-up appointments.

* Coordinated all care for enrolled patients to ensure study implementation and data collection.

* Performed literature searches and prepared literature reviews for patients and their families.

* Evaluated and analyzed clinical research data.

* Coordinated and ensured accurate study conduct for protocols; disseminated reports to committees.

* Reviewed/revised development of database features with programmer for use by staff.

* Authored policies & procedures related to the new database.

* ICD-9 experience in database management.

* Insurance verification experience.

* Direct administrative support to faculty; experience with research/academic functions; grant/manuscript submissions.

* Supervised office/clinic staff for 8 physicians.

BAYLOR COLLEGE OF MEDICINE 07/03-11/06

Lead Project Coordinator

Center for Cell & Gene Therapy

* Assisted in creation, development, testing and maintenance of database for research studies and patients.

* Analyzed and ensured accurate data collection/entry and abstraction; identified database problems and fixes.

* Collected and entered patient data; including reports and summations of research data for review.

* Coordinated and scheduled research patients appointments for tests and procedures related to studies.

* Interfaced with prospective patients/families, shared and explained applicable educational materials.

* Assisted in determining patient eligibility for research studies; including assurance of on-going eligibility.

* Participated in various investigator and coordinator clinical research meetings.

*Coordinated project activities to meet the goals and deadlines of the studies.

*Assisted in the development and implementation of project policies and procedures.

*Prepared documentation necessary to obtain initial and continued IRB approval for the specific research protocols.

*Organized research protocols as designated by specific protocol guidelines and Primary Investigator specifications.

*Conduct patient interviews to evaluate patient eligibility for study.

*Entered study data into a computerized database and case report forms; including patient charts for Primary Investigators

and hospitals.

* Maintained records for clinical studies and regulatory documents.

* Completed, maintained and updated patient files, case report forms and adverse event reporting.

* Created scheduled reports and prepared audits for DRC, IRB, FDA committees and agencies.

* Determined patient-specific health needs; including creation/implementation of tailored plan of care and patient calendar.

* Worked with clinical specialists and physicians at various Medical Center Hospitals and private physicians regarding

referred patients; including sharing of information as allowed by HIPPA.

* Assisted in the screening, interviewing and final decision process for prospective employees.

* Contact for physicians regarding in patient/out patient status and disseminated information to staff.

* ICD-9 experience in database management.

* Insurance verification experience.

* Direct administrative support to faculty; experience with research/academic functions; grant/manuscript submissions.

* Supervised office/clinic staff for 8 physicians.

UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER 09/98-07/03

Database Specialist, Data Management/Information Systems

Harris County Psychiatric Center

* Performed data entry, analysis and quality control of data collection systems for hospital-wide departments.

* Evaluated the credibility and integrity of primary procedures related to databases/patients.

* Synthesized patient data into summary tables, graphs, spreadsheets and reports for presentations hospital-wide.

* Reviewed all patients charts monthly to ensure accuracy, quality control for clinical and data purposes.

* Reported time-sensitive patient data to MHMRA to ensure ongoing funding.

* Created hospital-wide resource indicators and various data collection instruments/methodologies.

* Prepared graphical representation of data to hospital-wide committees for trend tracking.

* Worked with programmer to build and implement new database to capture patient information.

* Insurance verification experience.

* Clinical trials encompassing psychology and psychiatric patients; including assessments/enrollment/screening.

UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER 09/97-09/98

Senior Support Specialist, Quality Programs

Harris County Psychiatric Center

* Maintained and reconciled monthly budget reports and BUY CARD transactions using database.

* Processed requests and consulted with staff regarding FMLA standards and requests.

* Monitored staff files for continuing education, compliance and training; entered data and updated database.

* Prepared personnel action requests for salary adjustments, transfers and terminations using database.

* Tracked and reported weekly time sheets for staff using database.

* Created graphical storyboard projects highlighting patient and departmental progress using database and collected data.

* Analyzed patient satisfaction surveys; provided results/suggestions for customer service improvement per data results.

Houston Independent School District 05/90-08/97

School Registrar

* Reported student data and faculty attendance for state compliance and funding.

* Maintained student records/data and faculty personnel files.

* Managed grade reporting, including data/reporting for the State of Texas.

* Performed as Site Coordinator for data entry regarding student demographic information.

* Registered incoming students and withdrew transferring students; updated database.

* Transferred student records to receiving schools. Requested transfer student records.

* Handled monies for school lunch program.

* Assisted school Principal in various duties including general office supervision of 10 staff, 45 teachers and 850 students.

EDUCATION - 143 credit total hours

Houston Baptist University, earned 79 credits

Houston Community College, earned 12 credits

University of Texas at Austin, earned 52 credits

CERTIFICATION

Currently attending classes for Certification

COMPUTER SKILLS

Microsoft Applications: Outlook, Word, Excel, Access, PowerPoint, Windows XP, Internet, EPIC, Logician

ADDITIONAL SKILLS

Completely Bilingual-Spanish: speaking/reading/writing. Ability to work in various capacities and multi-task. Advanced level in data entry and analysis. Proficient in medical terminology. Experience in project analysis and evaluation. Solid interpersonal and customer service skills. ICD-9 experience in database management. Experience managing clinical trials/protocols and interacting/testing/enrolling psychiatric patients within the extensive psychology realm. Knowledge and practical use of the DSM IV.

STUDIES AND DISEASES WHILE CLINICAL RESEARCH COORDINATOR/PROJECT MANAGER:

Lymphoma (including CLL), Leukemia (Acute and Chronic Myeloid), Hemophagocytic Disease, Hodgkins Disease. Neuroblastoma Nasopharyngeal Carcinoma

Phase I/II Study of anti-Human CD45 monoclonal Antibodies in Patients with Advanced Leukemia prior to Allogeneic Stem Cell Transplantation: This study uses monoclonal antibodies and high dose chemotherapy and radiotherapy combined with autologous stem cell transplantation to treat patients with hematologic malignancies.

Phase I/II Study of CD45 Antibodies and Alemtuzumab Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation of Patients with Hematological Diseases: This study uses monoclonal antibodies and low dose chemotherapy and radiotherapy combined with allogeneic stem cell transplantation to treat patients with hematologic malignancies who also have other complications such as kidney, liver, or heart disease.

CD34-selection for ex vivo T-cell Depletion of Mobilized Peripheral Blood Stem Cells for Recipients of HLA Haploidentical Related Donor Stem Cell Grafts Receiving Intensive Conditioning: This study uses a monoclonal antibody and high dose chemotherapy and radiotherapy combined with haploidentical allogeneic stem cell transplantation to treat pediatric patients with hematologic malignancies.

Administration Of LMP Specific Cytotoxic T-Lymphocytes To Patients With Relapsed EBV-Positive Hodgkin Disease: This study uses autologous EBV specific T-Lymphocytes targeting the EBV proteins LMP1 and LMP2 to treat lymphoma.

Treatment of Chronic Lymphocytic B-Leukemia (B-CLL) with Human IL-2 and CD40 Ligand Plasmid Gene Modified Autologous Tumor Cells: This study uses autologous gene modified tumor cells (also referred to as a vaccine) which release IL-2 and CD40L to treat patients with CLL.

Treatment of Chronic Lymphocytic B-Leukemia (B-CLL) with Human IL-2 Gene Modified and Human CD40 Ligand-Expressing Autologous Tumor Cells after Depletion of Regulatory T Cells: This study uses a combination of monoclonal antibodies and autologous gene modified tumor cells (also referred to as a vaccine) which release IL-2 and CD40L to treat patients with CLL.

Prolonged Immunisation with Autologous CD40 Ligand and IL-2-expressing Tumor Cells for Treatment of B-Chronic Lymphocytic Leukemia (B-CLL): This study uses autologous gene modified tumor cells (also referred to as a vaccine) which release IL-2 and CD40L to treat patients with CLL given over a longer period of time than other studies.

Administration Of LMP Specific Cytotoxic T-Lymphocytes To Patients With Relapsed EBV-Positive Hodgkin Disease: This study uses autologous EBV specific T-Lymphocytes targeting the EBV proteins LMP1 and LMP2 to treat lymphoma

Administration of Peripheral Blood T-Cells and EBV Specific CTLs Transduced to Express GD-2 Specific Chimeric T Cell Receptors to Patients with Neuroblastoma: This study uses EBV and 14G2a (a neuroblastoma specific antibody) specific T-Lymphocytes to treat patients with neuroblastoma.

Phase I/II Study of Immunization with Lymphotactin and Interleukin 2 (IL2) Gene Modified Neuroblastoma Tumor Cells after High-Dose Chemotherapy and Autologous Stem Cell Rescue in Patients with High Risk Neuroblastoma: This study uses a vaccine made from allogeneic neuroblastoma tumor cells which have been modified to release lymphotactin and IL-2. The vaccine will be given to patients that also receive chemotherapy and a stem cell transplant.

Phase I/II Study of Allogeneic Stem Cell Transplantation for Patients with Hematologic Malignancy, Using Haploidentical Family Donors and Sub-Myeloablative Conditioning with Campath 1H: This study uses a monoclonal antibody, low dose chemotherapy and radiation combined with haploidentical allogeneic stem cell transplantation to treat patients with hematologic malignancies who have already received a stem cell transplant or who also have other complications such as kidney, liver, or heart disease.

Administration of EBV-Specific T-Lymphocytes to Patients with EBV-Positive Nasopharyngeal Carcinoma: This study uses autologous EBV specific T-Lymphocytes to treat nasopharyngeal carcinoma.

Administration Of LMP1- And LMP-Specific Cytotoxic T-Lymphocytes To Patients With EBV-Positive Nasopharyngeal Carcinoma: This study uses EBV specific T cells to treat patients with EBV positive NPC.

Administration of LMP1 and LMP2 Specific Cytotoxic T Lymphocytes Following CD45 Antibody Administration to Patients with EBV-Positive Nasopharyngeal Carcinoma: This study uses EBV specific T cells in combination with a monoclonal antibody to treat patients with EBV positive NPC.

A PHASE III, LONG TERM, RANDOMIZED, OPEN LABEL STUDY TO EVALUATE THE SAFETY OF DROPER ON SUBJECTS DIAGNOSED WITH STAGE I HYPERTENSION

CHANGES IN INFLAMMATORY BOWEL DISEASE WITH MENOPAUSE

MID-ATLANTIC AFRICAN AMERICAN IBD (INFLAMMATORY BOWEL DISEASE) STUDY (MAAAIS)

EUS EVALUATION OF PERIANAL AND PERI-RECTAL FISTULIZING CROHN'S DISEASE WITH CERTOLIZUMAB TREATMENT

A MULTI-CENTER NATIONAL PROSPECTIVE STUDY OF PREGNANCY AND NEONATAL OUTCOMES IN WOMEN WITH INFLAMMATORY BOWEL DISEASE EXPOSED TO IMMUNOMODULATORS AND BIOLOGIC THERAPY

A NON-INTERVENTIONAL LONG TERM POST MARKETING REGISTRY OF PATIENTS TREATED WITH CERTOLIZUMAB PEGOL (CIMZIA) FOR CROHN'S DISEASE

THE ROLE OF RACE AND ETHNICITY ON INFLAMMATORY BOWEL DISEASE (IBD)

FUNCTIONAL DYSPEPSIA TREATMENT TRIAL

CD INFORM: INVESTIGATING NATALIZUMAB THROUGH FURTHER OBSERVATIONAL RESEARCH AND MONITORING

A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF USTEKINUMAB THERAPY IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY TREATED WITH TNF ANTAGONIST THERAPY – CERTIFI

PATIENT ASSISTANCE PROGRAM AND COMPLIANCE OF TREATMENT FOR HEPATITIS C

A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, BLINDED, MULTICENTER STUDY OF THE INDUCTION AND MAINTENANCE OF CLINICAL RESPONSE AND REMISSION BY VEDOLIZUMAB (MLN0002) IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, BLINDED, MULTICENTER STUDY OF THE INDUCTION AND MAINTENANCE OF CLINICAL RESPONSE AND REMISSION BY VEDOLIZUMAB (MLN0002) IN PATIENTS WITH MODERATE TO SEVERE CROHN'S DISEASE

A PHASE 3, OPEN-LABEL STUDY TO DETERMINE THE LONG TERM SAFETY OF VEDOLIZUMAB (MLN0002) IN PATIENTS WITH ULCERATIVE COLITIS AND CROHN'S DISEASE

USE OF CURCUMIN FOR MILD TO MODERATELY ACTIVE ULCERATIVE COLITIS: A RANDOMIZED, DOUBLE BLINDED, PLACEBO CONTROLLED PILOT STUDY

RESPONSE TO INFLIXIMAB FOR ACTIVE ULCERATIVE COLITIS (UC): REPOSITORY TO COLLECT SPECIMENS AND CLINICAL DATA FROM UC PATIENTS RECEIVING INFLIXIMAB (REACT STUDY)

DETERMINATION OF THE OPTIMAL DOSE OF METHOTREXATE BY MEASURING METHOTREXATE

POLYGLUTAMATE LEVELS IN CROHN'S DISEASE PATIENTS

HAIRLOSS IN INFLAMMATORY BOWEL DISEASE

TRANSITIONING OF INFLAMMATORY BOWEL DISEASE PATIENTS FROM PEDIATRIC TO ADULT CARE

A PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF INTRAVENOUS INFUSION OF HUMAN PLACENTA-DERIVED CELLS (PDA001) FOR THE TREATMENT OF ADULTS WITH MODERATE-TO-SEVERE- CROHN'S DISEASE

RANDOMIZED, DOUBLE BLIND, PROSPECTIVE TRIAL INVESTIGATING THE EFFICACY OF METHOTREXATE IN INDUCTION AND MAINTENANCE OF STEROID FREE REMISSION IN ULCERATIVE COLITIS (METHOTREXATE RESPONSE IN TREATMENT OF UC - MERIT-UC)

PROSPECTIVE, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL COMPARING REMICADE (INFLIXIMAB) AND PLACEBO IN THE PREVENTION OF RECURRENCE IN CROHN'S DISEASE PATIENTS UNDERGOING SURGICAL RESECTION WHO ARE AT AN INCREASED RISK OF RECURRENCE

PHASE I, OPEN LABEL SAFETY STUDY OF VSL#3 IN ADULTS WITH IRRITABLE BOWEL SYNDROME

IMPACT OF DIET AND NUTRITION ON INFLAMMATORY BOWEL DISEASE

COMPARISON OF APRISO VERSUS APRISO AND RIFAXIMIN FOR ACTIVE UC

LONG-TERM OUTCOME OF INFLAMMATORY BOWEL DISEASE PATIENTS

PROSPECTIVE, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIALCOMPARING REMICADE® (INFLIXIMAB) AND PLACEBO IN THE PREVENTION OF RECURRENCEIN CROHN’S DISEASE PATIENTS UNDERGOING SURGICAL RESECTION WHO ARE AT ANINCREASED RISK OF RECURRENCE-PREVENT

PUBLICATIONS:

www.biomedexperts.com/Profile.bme/452002/Adrian Gee

www.bcm.edu/clinicalstudies/index.cfm?pmid=7190

www.bcm.edu/medicine/gi/index.cfm?PMID=12506

http://www.isbtc.org/meetings/am07/presentations/saturday/brenner.pdf

clincancerres.aacrjournals.org/cgi/reprint/11/19/6916.pdf

www.labome.org/expert/usa/baylor/rice/l-rice-223934.html

leukemia.physiciansforpatients.com/do/clinical-trials/1825

https://www.bcm.edu/cancercenter/clinicaltrials/.../PRMS%20org%20chart.pdf

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