Guidelines for the preparation of protocol and documents in clnical trials
resume
1. Marcie Ann Popovich
2173 Gallagher Court, Las Vegas, NV 89117 • (724)462-0242 • marcie.a.popovich@gmail.com
OBJECTIVE: I am seeking to obtain a position in an environment where I am able to utilize my personal
experience as well as teamwork abilities. Moreover, I would like to put into practice the vast array of work-related
experience I possess to complete the task at hand.
EDUCATIONAL BACKGROUND
Community College of Allegheny County Pittsburgh, Pennsylvania
First Responder Training/Certification
Garfield Business Institute New Brighton, Pennsylvania
Medical Secretarial/Assistant
PROFESSIONAL EXPERIENCE
JDR Dermatology Research (Formerly Del Rosso Dermatology Research) Las Vegas, Nevada
April 2015-Present
Clinical Research Coordinator
• Reports primarily to the Principal Investigator with associated responsibilities to the director of clinical
research
• Ensures that clinical research and related activities are performed in accordance with Federal Regulations
and sponsoring agency (pharmaceutical and/or CRO) policies and procedures
• Assists the PI in study feasibility assessments as requested
• Reviews and comprehends the protocol
• Attends investigator meetings as required
• Prepares IRB and any other regulatory submission documents as required by the protocol
• Prepares other study materials such as, the informed consent document, source documents, enrollment
logs, drug/device accountability logs and temperature logs
• Establishes and organizes study files, including: regulatory binders, study specific source documentation
and other materials
• Reviews and develops a familiarity with the protocol such as: study proceedings and timelines, inclusion
and exclusion criteria, confidentiality, privacy protections
• Assists PI in communication of study requirements to all individuals involved in the study and provides
appropriate training for study team members
• Collects documents needed to initiate the study and submit to the sponsor (FDA Forms 1572, CVs, etc.)
• Develop and implement recruitment strategies in accordance with (IRB) requirements and approvals.
• Conducts or participates in the informed consent process
• Develops advertising and other informational materials to be used in subject recruitment
• Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each
potential participant’s eligibility or exclusion
• Coordinates participant tests and procedures such as: draws blood or collects urine sample for laboratory
testing as specified by the protocol
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2. Marcie Ann Popovich
2173 Gallagher Court, Las Vegas, NV 89117 • (724)462-0242 • marcie.a.popovich@gmail.com
• Prepares the specimens for shipping to laboratory
• Collects data and preforms assessments specified in the protocol; vitals, questionnaires, EKG, photos
• Ensures timely completion of Case Report Forms
• Maintains study timelines
• Maintains adequate inventory of study supplies
• Dispenses study drug to study patients & maintains accountability
• Completes study documentation and maintains study files in accordance with sponsor requirements.
• Track enrollment and visit status of subjects
• Retains all study records in accordance with sponsor requirements
• Maintains effective and ongoing communication with sponsor, research participants and PI during the
course of the study
Las Vegas Skin & Cancer Clinics Las Vegas, Nevada
February 2010-April 2015
Clinical Research Coordinator/Medical Assistant/Front Desk Supervisor
• Work with CRO’s and/or Sponsor’s to initiate new studies at site
• Complete study start-up/regulatory documents
• Subject recruitment
• Meet with CRA’s during their monitoring and/or qualifying visits
• Complete continuing regulatory documents for all studies
• Invoice for subject stipends
• Create source documents for every study
• Conduct all patient visits and assessments per study protocol
• Adhere to all Local and Central IRB requirements for each trial
• Diligent documentation of any protocol variances
• Perform venipuncture and specimen collection
• Process and package lab specimens to be sent to the central lab
• Complete source documents and case report forms
• Complete Close-out visits with CRA’s upon study completions
• Perform ECG’s and transmit to Sponsors per protocols
• Assist Physicians in study assessments
• Assist in all aspects of the back office (MOHS surgery, injections, slide prep, biopsies)
• Resolve employee conflicts and handle patient complaints
• Complete weekly schedules for employees
• Answer a multiline telephone system
• Assist vendors and representatives coming into the clinic
• Help resolve billing and referral questions
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3. Marcie Ann Popovich
2173 Gallagher Court, Las Vegas, NV 89117 • (724)462-0242 • marcie.a.popovich@gmail.com
Tri-State Medical Group, Darlington Darlington, Pennsylvania
July 2009-December 2009
Office Manager
Resolve employee conflicts and handle patient complaints
Complete weekly schedule for employees
Process employee payroll
Manage cash flow and complete daily deposits
Inventory and order supplies as needed
Assist in the front office (multiline phone answering, check in, check out, referral processing)
Assist in the back office (rooming patients, preparing procedures, administering injections)
Support the physician and physician assistant in all aspects of the office
Alexander and Gretchen Kalenak Aliquippa, Pennsylvania
February 2008-December 2009
Personal Nanny
• Provide care and support to two children
• Prepare three meals daily
• Complete laundry, cleaning and shopping for the household
• Assist with homework responsibilites
• Drive the children to their extra curricular activities and assist in practices
• Schedule and transport the children to physician/dental appointments
• Attend school functions and meetings
• Resolve conflict amongst siblings
• Enstill values for childhood development
Tri-State Medical Group, Cardiology Beaver, Pennsylvania
February 2002-February 2008
Clinical Research Coordinator
• Reports primarily to the Principal Investigator with associated responsibilities to the director of clinical
research
• Ensures that clinical research and related activities are performed in accordance with Federal Regulations
and sponsoring agency (pharmaceutical and/or CRO) policies and procedures
• Assists the PI in study feasibility assessments as requested
• Reviews and comprehends the protocol
• Attends investigator meetings as required
• Prepares IRB and any other regulatory submission documents as required by the protocol
• Prepares other study materials such as, the informed consent document, source documents, enrollment
logs, drug/device accountability logs and temperature logs
• Establishes and organizes study files, including: regulatory binders, study specific source documentation
and other materials
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4. Marcie Ann Popovich
2173 Gallagher Court, Las Vegas, NV 89117 • (724)462-0242 • marcie.a.popovich@gmail.com
• Reviews and develops a familiarity with the protocol such as: study proceedings and timelines, inclusion
and exclusion criteria, confidentiality, privacy protections
• Assists PI in communication of study requirements to all individuals involved in the study and provides
appropriate training for study team members
• Collects documents needed to initiate the study and submit to the sponsor (FDA Forms 1572, CVs, etc.)
• Develop and implement recruitment strategies in accordance with (IRB) requirements and approvals.
• Conducts or participates in the informed consent process
• Develops advertising and other informational materials to be used in subject recruitment
• Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each
potential participant’s eligibility or exclusion
• Coordinates participant tests and procedures such as: draws blood or collects urine sample for laboratory
testing as specified by the protocol
• Prepares the specimens for shipping to laboratory
• Collects data and preforms assessments specified in the protocol; vitals, questionnaires, EKG, photos
• Ensures timely completion of Case Report Forms
• Maintains study timelines
• Maintains adequate inventory of study supplies
• Dispenses study drug to study patients & maintains accountability
• Completes study documentation and maintains study files in accordance with sponsor requirements.
• Track enrollment and visit status of subjects
• Retains all study records in accordance with sponsor requirements
• Maintains effective and ongoing communication with sponsor, research participants and PI during the
course of the study
• Presented to the emergency department to complete labs in the event of myocardial infarction subjects
KEY PROFICIENCIES
Computer Skills
• Google sites, Documents, & Calendars (Proficient); Microsoft Access, Excel, Outlook, PowerPoint,
Publisher, & Word (Proficient); Adobe Acrobat Professional (Proficient); Medidata Rave EDC (Proficient);
Inform EDC (Proficient); Canfield Scientific (Proficient); Medrio EDC (Proficient).
Research-Specific
• ICH & GCP Guidelines (Proficient); Hazardous Goods Handling (Proficient); FDA Requirements (Proficient)
Patient Care
• Ability to cater to all patients regardless of community standing, ensure the client is happy with services
provided as well as maintaining appropriate continuous communication with long-standing clients.
o Phlebotomy
o Vital Signs
o CPR/AED Certified (Active)
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5. Marcie Ann Popovich
2173 Gallagher Court, Las Vegas, NV 89117 • (724)462-0242 • marcie.a.popovich@gmail.com
o EKG
o Certified First Responder
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6. Marcie Ann Popovich
2173 Gallagher Court, Las Vegas, NV 89117 • (724)462-0242 • marcie.a.popovich@gmail.com
o EKG
o Certified First Responder
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