Sponsor Referral Coordinator
Resume:
Ernest Evans
**** **** ** *** *** Bladensburg MD 20710 (cell) 202-***-**** email:**************@*****.***
PROFESSIONAL EXPERIENCE
Senior Data Manager
Virginia Cancer Specialist 4/2020 – Present
Fairfax, VA
Knowledgeable of all assigned protocols and reporting requirements. Transmits and distributes protocol information. Responsible for submission, verification, and maintenance of protocol specific information on the Research Protocol Library, as appropriate.
Maintains regulatory binder for each assigned protocol. With assistance, prepares and submits annual renewal requests, amendments and adverse event reports with clinical input according to IRB and Sponsor requirements. Adheres to all protocol requirements to ensure the validity of the clinical research data.
Assist the principal investigator and/or program manager in defining information and plans required to accomplish goals of studies. May help design and create protocol specific data collection forms with assistance.
Verifies patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements.
Confirms patient registrations and relevant data points in databases for the Clinical Research Office and Oncology Information Systems.
Maintains a research chart for each patient. Collects, enters and compiles clinical data from a variety of sources.
Ensures accuracy and timeliness of data so that information can be used by the physician in treatment planning for individual patients, presentations and publication.
Verifies and schedules patient appointments, tests, and followup visits at the appropriate time in the treatment cycle to ensure completion of protocol requirements.
Designed and compile materials which aid physicians/other staff in complying with protocol requirements for these visits and tests.
Senior Clinical Research Coordinator
Maryland Oncology Hematology 1/2018 – 4/2020
Brandywine, MD
Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on protocol.
Coordinates patient care in compliance with protocol requirements. May disburse investigational drug and provide patient teaching regarding administration. Maintains investigational drug accountability.
Collaborates with the physicians, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.
Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities.
Maintains regulatory documents in accordance with USOR SOP and applicable regulations.
Responsible for education of clinic staff regarding clinical research.
Collaborates with Research Site Leader in the study selection process.
Additional responsibilities include working directly with other (non-USOR) research bases and/or sponsors.
Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.
Responsible for compiling and reporting protocol activity, accrual data, and research financial information to practice administration and physicians.
Oversees the preparation of orders by physicians to assure that protocol compliance is maintained. Communicates with physician regarding study requirements, need for dose modification, and adverse event reporting.
Provides a safe environment for patients, families, and clinical staff at all times through compliance with all federal, state, and professional regulatory standards as issued through OSHA and the CDC.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Senior Clinical Research Coordinator
Georgetown University Hospital
Lombardi Cancer Center 1/2016 -1/2018
Washington DC
Screens patients for clinical trials, to include patient eligibility, and assists in the consent process.
Collects, prepares, and organizes data into case report forms, databases, and other required formats.
Assists physicians in completing flow-sheets in medical records and progress notes.
Participates in site initiation visits, monitoring visits and audits, and schedules audits with pharmaceutical sponsors and other agencies.
Reports and documents serious adverse events.
Monitors, records and reports patient’s condition and reaction to drugs and treatments to the appropriate physician/nurse.
Ensures that all pre-study laboratory/medical tests are completed and that eligibility requirements are completed.
Arranges pre- and post-procedure laboratory/medical tests.
Acts as a liaison with nurses, staff, physicians, pharmaceutical companies and federal agencies in regards to patients that are on clinical trials.
Schedules in-service for appropriate staff, provides patient education about treatment and possible side effects.
Performs all duties in accordance with all applicable laws and regulations and with Georgetown University Medical Center’s philosophy, policies, procedures and standards – to include Protection of Human Subjects and patient confidentiality.
Research Program Lead
Medstar August 2013- April 2015
Division of Endocrinology & Metabolism, Hyattsville, MD
Assists in direct management of the clinical research program, assisting in supervising clinical research staff and overseeing program activities.
Primary Essential Duties
Assists in the oversight of recruitment and enrollment efforts for the clinical trials program, periodically acting as the clinical liaison between medical providers and research staff at Whitman-Walker as well as within the research community at large.
Day to day oversight of the screening and evaluation of potential trial patients
Provides information about current and upcoming trials to the health center’s medical providers
Assists in ensuring that research staff strictly adheres to research protocols (e.g. records are properly maintained, drugs properly stored, labs processed according to protocol, and all processes are carried out in accordance with the study’s IRB of record).
Assists in implementing internal quality control measures, adjusting staffing and internal protocols/procedures, as necessary
Provides direct primary care to trial patients when appropriate, making referrals and following up
Builds and maintains productive relationships with sponsors and the health center’s research network
Problem solves technical issues with staff and uses excellent judgment to inform the Director of Clinical Research of atypical activities and issues
Other duties as assigned
Budget Responsibilities
Collaborates with administrative and financial staff to assist Director of Clinical Research in managing funding sources, expenses, and revenue.
Management Responsibilities
Assists in supervising the activities of clinical investigation staff under the direction of the Director of Clinical Research
Develop audit schedules; conduct clinical and non-clinical trial audits
Review clinical protocols and reports to ensure appropriate quality for the intended purpose
Prepare and/or review written reports for audits and inspections
Research Program Coordinator
Johns Hopkins University School of Medicine Nov. 2012- July 2014
Division of Endocrinology & Metabolism, Baltimore, MD
Responsible for coordinating Clinical Research Activities related to studies, including monitoring the progress of research protocol for multi-center studies, collection of research data on patients entered in research protocols, date management and entry, carrying out day to day activities such as meeting the goals of a variety of research projects.
Responsible for organization, entry, maintenance, and accuracy of all patient clinical research data in a timely and ongoing manner.
Maintains good working knowledge of all assigned protocols, maintains regulatory binder for each assigned protocol, maintains a research chart for each patient, may assist principal investigator in defining information and plans required to accomplish goals of studies.
Verify patient eligibility for studies and meets regularly with principal investigators and supervisors of studies for review data accuracy and overall progress.
Research Data Manager
Johns Hopkins Hospital Aug. 2011- Nov. 2012
Sidney Kimmel Cancel Center, Baltimore, MD
Knowledgeable of all assigned protocols and reporting requirements. Transmits and distributes protocol information. Responsible for submission, verification, and maintenance of protocol specific information on the SKCCC Research Protocol Library, as appropriate.
Maintains regulatory binder for each assigned protocol. With assistance, prepares and submits annual renewal requests, amendments and adverse event reports with clinical input according to IRB and Sponsor requirements. Adheres to all protocol requirements to ensure the validity of the clinical research data.
Assist the principal investigator and/or program manager in defining information and plans required to accomplish goals of studies. May help design and create protocol specific data collection forms with assistance.
Verifies patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements.
Confirms patient registrations and relevant data points in databases for the SKCCC Clinical Research Office and Oncology Information Systems.
Maintains a research chart for each patient. Collects, enters and compiles clinical data from a variety of sources.
Ensures accuracy and timeliness of data so that information can be used by the physician in treatment planning for individual patients, presentations and publication.
Verifies and schedules patient appointments, tests, and followup visits at the appropriate time in the treatment cycle to ensure completion of protocol requirements.
Designed and compile materials which aid physicians/other staff in complying with protocol requirements for these visits and tests.
Clinical Research Coordinator
Emory University Hospital Nov. 2004- Aug. 2011
Winship Cancer Institute, Atlanta, GA
Evaluate new and/or relapsed/refractory patients for initial eligibility for research trials and communicate those findings to attending Physicians, clinical staff, and members of the team.
Provide interdisciplinary communication and coordination between Physicians, mid-level providers, clinical staff, sponsoring agencies and patient/families involved in clinical trials.
Maintain clinical database including obtaining subject consents, extracting data from medical records and querying reports.
Serve as a fully participatory team member and a resource for data management and computer expertise.
Administer clinical coordination logistics and database knowledge for other team members and clinical research staff.
Develop and maintain tracking reports, scorecards, and other tools to monitor quality
Develop audit schedules; conduct clinical and non-clinical trial audits
New Patient Referral Coordinator
Emory University Hospital Nov. 2002- Nov. 2004
Winship Cancer Institute, Atlanta, GA
Coordinated the daily clinical operations for health care professionals.
Resolved problematic issues and managed risks.
Served as a liaison for the clinical team with the billing office and department administration.
Addressed patient concerns and, if required, referred patients to appropriate resources.
Ensured patient visits and procedures are pre-authorized by third-party payers, managed care organizations and HMO’s.
Patient Service Agent/Call Center Coordinator
Emory University Hospital Nov. 1997- Nov. 2002
Winship Cancer Institute, Atlanta, GA
Answered and screened all cancer patient, Physician and family member calls and correspondence.
Verified all insurance coverage and obtained referrals as needed.
Responsible for researching and resolving complaints to ensure customer satisfaction.
Ordered medication via Lotus Notes, signaled urgent matters and followed-up on calls from patients.
Scheduled patients through IDX database for appointments, new patient visits, procedures and infusions.
EDUCATION/CERTIFICATION & TRAININGS
Project Management, Certified Associate in Project Management (CAPM),
University of the District of Columbia Community College, 50 hours, Apr 2017
Dealing with difficult people. Grace Hill certification Nov. 2015
Prince George’s Community College, Largo, MD Sept. 2012- Present
Health and Information
Atlanta Metropolitan College, Atlanta, GA Sept. 2007-June 2011
Biology Major
Goldey Beacom College, Greenville, Delaware June 2001
Collaborative Institutional Training Initiative (C.I.T.I.) Certification Sept. 2016
ADDITIONAL SKILL/PROGRAM SYSTEMS
Typing skills 50 wpm
SAP System, IDX System
EPR System
Microsoft Office 2007/2010
Meditech System
Epic System
Medical Terminology Training
EKG Tech
TrialMaster
PROFESSIONAL REFERENCES
Joan Giblin, Nurse Manager, Winship Cancer Institute 404-***-****
Imaan Khan MD, Maryland Oncology Hematology 618-***-****
Charles Rudin, Medical Director Johns Hopkins 410-***-****
Jillian Thompson NP, Lombardi Cancer Center 336-***-****
Marwa Enam Manager, VCS 202-***-****
Nicholas Baron Data Manager 703-***-****
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