Irina Mechikow

** ***** *** **** * • Shrewsbury, MA 01545

*** ****** *** • Newton, MA 02460 • 315-***-****

adzk0w@r.postjobfree.com

•Medical Professional offers multiyear experience and academic training in Clinical Research, Medical Practice, and Health Care Management.

•Solid medical background as Pediatrician and Medical Administrator in Ukraine, with proven clinical, analytical, and management skills.

•Technically proficient in Windows XP and Microsoft Office Suite.

Education

Master of Arts in Health Care Administration

FRAMINGHAM STATE UNIVERSITY 2010 to 2013

Doctorate in Pediatrics

L'VIV STATE MEDICAL UNIVERSITY L'VIV - Lviv, Ukraine

July 1990 to July 1996

Professional Experience

Clinical Research Coordinator- DM Clinical Research

DM Clinical Research

77 Pond Avenue, Ste 205c, Brookline, MA 02445

•The Clinical Research Coordinator I, will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor

•The CRC I will also ensure study enrollment meets or exceeds Sponsors' expectations

•To ensure company goals are achieved on a timely basis

•Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis

•Completing all the relevant training prior to study-start and on a continued basis in a timely manner

•Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training

•Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner

•Adherence to ALCOA-C Standards with all the relevant clinical trial documentation

•Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations

•Demonstration of appropriate and timely follow-up on the action items, at their respective sites

•Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols

•Liaising with Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols

•Submitting required administrative paperwork per company timelines

•Participating in subject recruitment and retention efforts

•Engaging with Research Participants and understanding their concerns

Clinical Regulatory Coordinator - Pediatric Infection Diseases

Boston Medical Center

670 Albany Street, Room 633, Boston, MA 02118

•Institutional Review Board (IRB) submissions and management for human clinical research trials in the Section, including cede review applications to commercial IRBs, new applications, amendments, continuing review reports, study personnel changes, safety report submissions per IRB policies and procedures, protocol deviations, etc.;

•Creation and maintenance of regulatory documents for research studies in the Section, primarily industry-sponsored, including but not limited to delegation logs, financial disclosures, 1572s, training tracking, communication with sponsor and CRO as applicable, study document maintenance and dissemination;

•Participation in site monitoring visits (pre-site selection, site initiation, and interim visits, plus follow-up after visits) for applicable research studies in the Section, including taking the lead or assisting in scheduling;

•Data management lead or backup for applicable human research studies, including data entry and query resolution;

•Regulatory liaison between the Section and the Investigational Pharmacy Service (IPS) at BMC for applicable studies, including completion of protocol worksheets for the IPS and setting up communication between the IPS and study team in Pedi ID;

•Velos-CT initial study submission and maintenance, and research visit entries, as applicable for human research studies in the Section;

•Maintaining and disseminating monthly active protocol lists for research studies in the Section;

•Disseminating email reminders/yearly schedules for, and taking research minutes at, monthly administrative/research meetings;

Clinical Research Coordinator II- Cardiovascular Medicine

UMass Memorial Medical Center - Worcester, MA

May 2020 to September 2020

•Provide support to project through implementation of work plans, and preparation of deliverables. Assist in the documentation of project writing and preparation of material for project meetings.

•Review treatment protocols as they are developed to ensure that the treatment guidelines are consistent throughout the document and the appropriate documentation for the central reviews of research intervention as specified.

•Develop protocol specific tools (e.g., treatment data and/or therapeutic checklists) to aid with data collection and submission.

•Set up the protocol treatment template in the department's database by abstracting the details of the protocol to aid in on-study patient tracking.

•Extract and transcribe treatment data from hospital and clinical records required to complete study patient's record and sponsor's case report forms. Monitors quality and timelines of data submissions.

•Monitors status of all studies in the database and ensures that all patient data (on-study and follow- up) are submitted, and responds to data queries from sponsoring organization, in a timely manner.

•Track and maintain accurate data of studies, accrual, and patient status activity in database.

•Maintains effective working relationships with research nurses and investigators participating in the study.

•Monitors strict adherence to protocols. Assures that cases are being finalized and reviewed by appropriate clinician.

•Prepares regular reports reviewing the status of the study. Reviews protocol requirements with physicians and research nurses. Identifies and resolve issues with protocol compliance. Keeps principal investigator and research nurse aware of any issues on compliance.

•Monitors notices from the Cooperative Group to ensure that protocol document has current amendments. Informs staff and updates database.

•Provides data to study investigators as requested and submits data to the Cooperative Groups for analysis. Runs quality control checks on data prior to transfer.

•Serves as a resource to physician and nurses to locate information for special reports and treatment decisions.

•Adheres to Good Clinical Practice (GCP) guidelines and all human subject protection practices.

•Participates in all office staff meetings. Presents current status of studies assigned.

•Participates in regularly held Protocol Review Committee meetings.

•Participates in the documenting work procedures specific to new studies.

•Perform other duties as required.

Clinical Research Coordinator II- Neurosurgery Department

UMass Memorial Medical Center - Worcester, MA

February 2019 to May 2020

Clinical Research Coordinator II- Neurocritical Care Unit, Department of Neurology

UMass Memorial Medical Center - Worcester, MA October 2016 to February 2019

•Provide support to project through implementation of work plans, and preparation of deliverables. Assist in the documentation of project writing and preparation of material for project meetings.

•Review treatment protocols as they are developed to ensure that the treatment guidelines are consistent throughout the document and the appropriate documentation for the central reviews of research intervention as specified.

•Develop protocol specific tools (e.g., treatment data and/or therapeutic checklists) to aid with data collection and submission.

•Set up the protocol treatment template in the department's database by abstracting the details of the protocol to aid in on-study patient tracking.

•Extract and transcribe treatment data from hospital and clinical records required to complete study patient's record and sponsor's case report forms. Monitors quality and timelines of data submissions.

•Monitors status of all studies in the database and ensures that all patient data (on-study and follow- up) are submitted, and responds to data queries from sponsoring organization, in a timely manner.

•Track and maintain accurate data of studies, accrual, and patient status activity in database.

•Maintains effective working relationships with research nurses and investigators participating in the study.

•Monitors strict adherence to protocols. Assures that cases are being finalized and reviewed by appropriate clinician.

•Prepares regular reports reviewing the status of the study. Reviews protocol requirements with physicians and research nurses. Identifies and resolve issues with protocol compliance. Keeps principal investigator and research nurse aware of any issues on compliance.

•Monitors notices from the Cooperative Group to ensure that protocol document has current amendments. Informs staff and updates database.

•Provides data to study investigators as requested and submits data to the Cooperative Groups for analysis. Runs quality control checks on data prior to transfer.

•Serves as a resource to physician and nurses to locate information for special reports and treatment decisions.

•Adheres to Good Clinical Practice (GCP) guidelines and all human subject protection practices.

•Participates in all office staff meetings. Presents current status of studies assigned.

•Participates in regularly held Protocol Review Committee meetings.

•Participates in the documenting work procedures specific to new studies.

•Perform other duties as required.

Clinical Research Coordinator I - Neurocritical Care Unit, Department of Neurology

UMass Memorial Medical Center - Worcester, MA

January 2015 to October 2016

•Contribute to the development of research protocols

•Gather and submit all required documentation to gain trial approval following strict IRB/FDA guidelines

•Conduct educational session with ICU staff

•Evaluate ICU patients for enrollment into appropriate research trial

•Process specimens and blood samples.

•Present a detailed description of the qualifying research trial to the patient and/or legal representative for possible enrollment

•Perform daily assessments of all drug study patients, including: drug infusion, reconciliation, lab result, AE's/SAE's criteria, mRS, NIHSS, GCS and others exams; providing all necessary information related to the ongoing trial to clinicians or patient/family;

•Maintain clinical trial databases (EDCs, WEBDCU, RedCAP, etc)

•Conduct weekly meetings with the research team

•Participate in the weekly neuroICU conference, Trauma and Grand rounds.

Clinical Research Assistant - Department of Emergency Medicine

UMass Memorial Medical Center - Worcester, MA

January 2014 to January 2015

•Perform all duties and procedures associated with the research studies under the responsibility of the physician investigators.

•Screen of potential participants for inclusion in the study.

•Enroll eligible subjects into research studies.

•Obtain follow-up information on subjects according to protocol requirements.

•Assist with the preparation and submission of protocols, amendments, adverse event reports, and other reports to the Institutional Review Board.

•Obtain medical history of patients and collect data from patient examinations.

•Manage existing database, create new databases for lab studies, perform data analysis

•Accurately organized, tracked and maintained study records and files including medical files.

•Attend investigators meetings and conferences with Principal Investigator whenever necessary.

•Maintain inventory of all supplies needed for clinical research including devices, lab kits, and medical supplies.

•Process specimens and blood samples.

Research Assistant

Cardiovascular Medicine - Worcester, MA

February 2013 to January 2014

•Collaborate with investigators in the design, development, and documentation of data forms, questionnaires, and other survey materials

•Responsible for aspects of the development of research recommendations and the design of research projects

•Participate in the grant, manuscript, and Internal Review Board process

•Develop overall research plan for conducting surveys in the community

•Recruit subjects for studies

•Monitor selection and randomization process of study participants

•Coordinate data collections of study participants, complete case report forms, develop and maintain spreadsheets

•Collect and maintain questionnaires and other data forms from study participant

•Perform literature searches and write detailed written summaries of the findings

•Collaborate with other project leaders on data presentation, interpretation and writing of scientific reports

•Develop and maintain computerized data files for all data to be collected

•Prepare summary reports and ongoing project evaluations for investigators

•Conduct quality control check on field data collection system

•Collaborate with other research sites to insure consistency between research sites and accuracy of documentation

•Process specimens and blood samples.

Research Data Coordinator – Volunteer

UMass Memorial Medical Center - Worcester, MA

December 2011 to February 2013

•Maintain all regulatory activities for assigned project

•Enter data in sponsors' Electronic Data Capturing System

•Create and update patient's screening and enrollment logs.

•Verify and resolve of queries of clinical trial data.

•Create study binders with required documentation and data forms.

•Implement procedures for data collection from patient charts and medical records.

•Evaluate and interpret collected data and prepare appropriate documents.

•Order supplies, scan, photocopy, print, and assist with processing for presentations

•Obtain and ship blood samples, cultures and other specimens for laboratory analysis

Support Lab Technician

Charles River Laboratory - Stone Ridge, NY

July 2009 to December 2009

•Ensured operation of equipment and use of supplies in compliance with the company's safety guidelines and procedures.

•Tasked with caring for laboratory animals, including cleaning, feeding, watering, bedding, husbandry, breeding and maintaining animal health.

Chief of Air Unit Medical Department

DEFENSE MINISTRY OF UKRAINE

2002 to 2005

•Supervised medical and diagnostic departments and laboratories, ensuring quality patient

•Conducted thorough quality assurance inspections of diagnostic, treatment, and record-keeping

Air Unit Medical Officer

DEFENSE MINISTRY OF UKRAINE

1998 to 2002

•Responsible for diagnosing military pilot health status based on clinical data, medical history, laboratory tests, and clinical assessments.

Medical Officer

DEFENSE MINISTRY OF UKRAINE

1997 to 1998

•Oversaw health evaluation and treatment of pilots and military personnel.

Pediatrician

L'VIV CHILDREN'S POLYCLINIC NO

1996 to 1997

•Provided medical care for children in ICU and ER departments.

Languages

•English, Russian, Ukrainian - Fluent

Military Service

Branch: AirForce Service Country: Ukraine Rank: Captain

June 1996 to October 2005

Assessments

Data entry: Accuracy — Familiar

January 2021

Entering data quickly and accurately

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