Clinical Research Manager
Resume:
DEBORAH B. UNGER
NEW YORK, NY 10024
*********@*******.***
EDUCATION:
Yeshiva University, MSW LMSW #061718
Thesis: “End of Life Issues in Terminally Ill Cancer Patients”
Intern, NRL Resources – Substance Abuse Outpatient Facility/Intern, Gilda’s Club – Cancer Support Community Hofstra University, BA
EXPERIENCE:
ST. LUKE’S ROOSEVELT HOSPITAL CENTER 2011-2012
Research Protection Programs Manager (RPPM)
• Responsible for the management of research protection and program development to ensure research compliance with federal regulations, state law, contemporary guidance and hospital policy.
• The point of contact for the research community; provides information regarding regulatory protection of the welfare of human subjects, animal care and use, responsible conduct of research and cost policy.
• Develop, maintain, and revise policies and procedures related to the responsible conduct of research, enhancement of IRB/IACUC operations and standard operating procedures for administrative functions.
• Identify and coordinate the translation of revised and new government regulations and guidance into compliant policy
• Develop and conduct educational workshops and training programs regarding policies and procedures, regulations and investigator responsibilities. Training program to include new investigator orientation, educational activities for Committee membership to stay abreast of current events and focused training based on findings from risk assessments and audits.
• Conduct research protection risk assessments/audits including but not limited to investigator conflict of interest, IRB proper use of expedited and exempt categories, IRB timeliness of staff, response and continuing review, IRB/IACUC completeness of meeting minutes, determine if protocols are implemented as approved.
OPTIMAL SOLUTIONS GROUP 2010-2011
Clinical Quality Improvement Specialist (home based)
• Focusing on the evaluation of quality improvement projects in Medicare managed care environments, the provision of technical support and education to health plan staff and the provision of clinical support for the maintenance of hospital quality measures and the review quality improvement initiatives. Utilize HEDIS measures.
• Provide technical support for the development and maintenance of performance measures to assess quality of care in hospital inpatient and outpatient departments.
• Design, deliver, and document educational programs and technical assistance initiatives.
• Evaluate the quality improvement activities of managed care organizations.
• Ensure compliance with legal and procedural guidelines and quality standards for outgoing deliverables.
• Communicate to the project team relevant facts on new developments in the area of hospital quality measures and their relevance to the projects at hand.
• Perform research and project management tasks, as assigned; assist with other health policy projects and projects in Optimal’s other research centers, if necessary.
UNITED STATES CENSUS BUREAU 2010-2010
Crew Leader Assistant, United States Census Bureau
• Managed a group of fourteen (14) enumerator’s
• Conducted daily meetings with enumerators to check for data compliance and review issues with tenants, doormen, and property managers
• Reviewed enumerators’ time sheets prior to submission to the Crew Leader.
• Assumed Crew Leader’s responsibilities in her absence.
• Met with Field Operating Supervisor (FOS) in Crew Leader’s absence and when requested,
• Travelled to the Local Census Office (LCO) when necessary; to pick up additional work for distribution to enumerator’s to attend meetings.
• Spearheaded the “blitz” operation during NFRU. This encompassed getting as many completed questionnaires completed on a weekend. managed the staff during this activity as the Crew Leader was not present. Was available to provide supplies, help out with doormen issues and difficult tenants.
HOSPITAL FOR SPECIAL SURGERY 2006-2010
Manager, Clinical Research, Clinical Research Administration 2008-2010
• Clinical Trial Facilitator for Metabolic Bone, Rehabilitation, Spine, Anesthesiology, Scoliosis, Metabolic Bone, Limb Lengthening, Nursing, Trauma, Foot & Ankle, Neurology, and Physiatry Departments.
• Liaison between sponsor and Principal Investigator on all clinical trial issues; budget, contract, staff.
• Manages the ongoing approval process of the contract and budget by collaborating with the Sponsor, Finance, and Legal Departments.
• Maintains ongoing established relationships with all sponsors.
• Evaluates Clinical Research Staff in each area with regard to current and upcoming clinical trials; trains staff according to each specific protocol; how to consent patients, how to manage their workflow.
• Establishes strong service relationships with Principal Investigators, Clinical Research Coordinators, and Sponsors for smooth protocol execution.
• Oversees, supervises, and trains each Clinical Research Coordinator responsible for the flow of their Clinical Trial.
• Monitors high risk studies within the institution as required by the CRRAC Committee (Clinical Research Regulatory Affairs Committee)
• Participates in weekly Trials Facilitation meetings with other members of Clinical Research Administration, Legal, and Technology Development.
• Produces a “Kick-Off” meeting with the Principal Investigator, Research Coordinator and every other departments that has any activity in the trial.
HOSPITAL FOR SPECIAL SURGERY 2006-2010
Manager, Clinical Research Staff, Clinical Research Department 2006-2007
• Manages (indirectly) a staff of seventy-five (75) Clinical Research Staff employees and one (1) directly.
• Manages all aspects of Trial Facilitation for the Anesthesiology, Scoliosis, Metabolic Bone, Limb Lengthening, Nursing, Trauma, and Physiatry Departments. This includes all activities associated with Clinical Trials, supervising the Clinical Research Staff’s study tasks, generating budgets and contracts, liaison among the sponsor, Principal Investigator, and Clinical Research Coordinator.
• Manages (indirectly) a staff of seventy-five (75) Clinical Research Staff employees and one (1) directly.
• Supervise and initiate all Medical Education programs pertaining to Clinical Research Staff.
• Develops and leads monthly Education meetings for Clinical Research Staff.
• Provide guidance to Clinical Research Staff during pharmaceutical company site visits.
• Generates meeting agendas, identifies valuable research-specific topics to enhance knowledge of attendees.
• Provide educational updates on current HSS policies and procedures for Clinical Research.
• Mentors new and existing clinical research staff on Good Clinical Practices and Hospital for Special Surgery (HSS) policies for conducting clinical research.
• Meets regularly with Clinical Research Staff to review current projects and to answer questions regarding Clinical Research related activities.
• Monitors and evaluates Clinical Research Staff retention and Time and Effort for each trial.
• Provides guidance, oversight and assistance to the Clinical Research Staff through helping to problem solve specific issues related to Clinical Research activities.
• As needed, works with new staff in preparation for external monitoring visits, attends external monitoring visit, etc.
• Provides guidance and recommendations to investigators regarding the staffing needs for a protocol or a research project. Provides feedback to investigators on existing Clinical Research Staff (6 Month and Annual Reviews).
• Performs telephone screening and in-person interviews of potential new Clinical Research Staff candidates. Documents impressions of interviews. As determined, recommends qualified candidates for second round interviews with investigators and or his designee.
• Creates Personnel Change Forms allocating budgets for Clinical Research Staff appropriately.
• Conducts Kick-Off meetings for new Clinical Trials with Clinical Research Coordinator and Principal Investigator.
• Conducts Clinical Research Staff evaluations and provides feedback to the Principal Investigator.
WEILL CORNELL MEDICAL COLLEGE (WCMC) 2001-2006
Compliance Manager, Research and Sponsored Programs 2002-2006
• Responsible for providing leadership, oversight, and corrective actions of research compliance activities for the Institutional Review Board (IRB) by conducting “for-cause” and “not-for-cause” audits.
• Educates Principal Investigators and Research Staff in Quality Assurance regarding Human Subject Research.
• Ensures that appropriate safety is provided for all involved in human subject research activities at the college.
• Creates research infrastructure with Clinical Research Coordinators at WCMC in departments where necessary.
• Implements and integrates Research Compliance Program for the WCMC.
• Investigates and analyzes “for-cause” audits; trends and conditions common throughout the institution.
• Develops and presents research-training, educational workshops, and programs based on audit outcomes and research community feedback.
• Created DVD for educating all staff conducting Clinical Research; Principal Investigators, Clinical Research Coordinators, Fellows, and Residents. These DVDs include “How To Consent A Patient, “How To Be Audit Ready”, and “How To Smoothly Run a Trial When the Coordinator is Absent”
• Facilitates a user-friendly administrative research environment for all WCMC research staff.
• Responds to internal challenges while focusing on minimizing risks associated with clinical research compliance.
Sr. Research Coordinator, Dept. of Neurology-Neuroscience/Memory Disorders Program 2001-2002
• Utilized Social Work credentials with research subjects where needed.
• Managed all Clinical Trials (including pharmaceutical company trials) for the Memory Disorders Program.
• Organized all financial budgets of Alzheimer’s Disease studies.
• Collaborated with Senior Medical Associate from Merck & Company on a monthly basis to receive protocol audits.
• Oversight of research subjects and informants for their scheduled research appointments to ensure proper neurological and medical assessments.
• Conducted Neuropsychological testing; Mini Mental Scale Examination, Hamilton Depression, Alzheimer’s Diagnostic Assessment Scale, and Blessed Dementia Scale with research subjects.
• Managed all aspects of recruitment (liaison with Human Resources, reviewing resumes, interviewing and checking references) for support and Clinical Research Staff.
MEMORIAL SLOAN-KETTERING CANCER CENTER (MSKCC) 1993 - 2001
Research Manager, Dept. of Thoracic Surgery 1999 - 2001
• Supervised, recruited, and trained Thoracic Surgery Clinical Research Staff; Research Study Assistants, Research Interns, and Research Nurse. Managed all Clinical Research for six (6) Thoracic Surgeons
• Spearheaded Sputum Induction Site for MSKCC with the induction protocol sponsored by Moffitt Cancer Center.
• Oversight for all cooperative and pharmaceutical group studies; create budget where necessary.
• Organized cooperative group protocol meetings with off-site and research staff in order to coordinate studies.
• Implemented standards for research protocol management, policies.
• Created Lung Advocacy Committee to educate patients with Lung Cancer by publicizing existing support groups.
• Initiated the design and systematization of departmental administrative needs: Thoracic Surgery Policy and Protocol manual for Fellows, Residents and Students.
• Coordinated multi-disciplinary clinical research projects by working with investigators to formulate
appropriate interfaces among hospital staff, research staff, and research management.
• Performed research administrative and regulatory functions for Thoracic Surgery; Institutional Review Board, amendments, consent forms, continuing review reports, closures, and all Cooperative Group communications.
• Reviewed random sample of protocols, records and databases for compliance with quality control.
• Assess data quality during interim and final analysis.
Research Data Coordinator, Dept. of Epidemiology and Biostatistics, 1997-1998
Data Mgmt. Resource Group
• Participated in the institutional auditing program for Clinical Research protocols as deemed by the Physician-In-Chief.
• Coordinated aspects of the design, implementation and maintenance of the institutional Clinical Research
Database (CRDB) specific to Memorial Sloan-Kettering Cancer Center.
Research Study Assistant, Dept. of Radiation Oncology 1995 - 1997
• Established and executed Quality of Life protocol for Head and Neck cancer patients; set up protocol and validated tools, IRB process.
• Coordinated: patient identification, staff communication, liaison, patient enrollment in clinic areas;
Medical Oncology, Radiation Oncology, Surgical Oncology, Dental, and Speech and Hearing Departments.
• Oversaw the flow of the Quality Life Issues for Head and Neck Cancer Patients through the approval process of accrued patients on CRDB.
Medical Secretary, Depart of Radiation Oncology
Showtime Networks, Inc.
Photography Coordinator, Public Relations Department
Advertising Assistant, Advertising Department
MTV Networks, Inc.
Secretary, Vice President, Western Sales Division
DDB Needham Worldwide
Creative Assistant, Creative Department
• Reported to the Director of Casting.
• Coordinated casting and go-see sessions.
• Assisted in the trafficking of actors and models for casting sessions.
• Interacted with talent, model agents/managers and outside studio professionals
• Scheduled meetings and appointments.
VOLUNTEER: 1993 - 2001
• Visited in-patients who preferred to talk with someone about their illness and/or other conversation.
• Helped patients where possible; getting them a book or magazine, fixing a pillow, calling a nurse.
OTHER
• Member of the Perfect Attendance Club, Memorial Sloan-Kettering, 1995-2001.
REFERENCES: Furnished upon request.
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