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Clinical Research Coordinator Resume Example

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CLINICAL RESEARCH COORDINATOR
Professional Summary

Focused Clinical Research Coordinator well-versed in study protocols, regulatory submissions, standard operating procedures, and general trial oversight. Excellent problem-solving abilities with a detail-oriented nature. Ready to bring over five years of related experience to a challenging new role.

Skills
  • Trial Management
  • Process Improvement
  • Microsoft Office
  • Study Contracts
  • Informed Consent
  • Regulatory Submissions
  • Publication Editing
  • Data Entry
  • Case Report Forms
  • Clinical Research
  • Adverse Events and Serious Adverse Events
  • Medication dispensing
  • Scheduling
  • Team management
  • Study Payments
  • Project Organization
  • Good Clinical Practices
  • Budgets
  • Study Protocols
  • IDE- Creation and Submission
  • Research SOPs Understanding
  • Data Collection
  • Recruitment
  • Documentation Requirements
  • Patient Safety
  • Patient Care
  • Specimen collections
  • Schedule Coordination
  • Marketing
Certifications
Certified Clinical Research Professional, SOCRA, 7/2018 Certified Clinical Medical Assistant, 6/2013
Work History
Clinical Research Coordinator, 02/2019 to Current
Advanced Dermatology – Lincolnshire, IL
  • Work With Principal Investigator and Sponsors to Facilitate Daily Trial Activities and Comply with Research Protocols.
  • Assist the Principal Investigator with Start-up of Two Investigator-Initiated Trials.
  • Assist in Writing Two Protocols and Informed Consent.
  • Prepare IDE for Investigator-Initiated Trials for FDA Review.
  • Handle all FDA Submissions, including IDE and Safety Determination Submissions.
  • Prepare Initial Review Form on Investigator-Initiated Trials for IRB approval.
  • Prepare Regulatory Submissions and Supporting Documents for IRB Review.
  • Responsible for Entering and Maintaining Data on Current Trials into clinicaltrials.gov.
  • Negotiate and Complete Clinical Research Contracts and Budgets for Various Studies.
  • Participate in Initiation Visits and Investigator Meetings, Implementing Trials in Accordance with Study Timelines and Budgets.
  • Monitor and Create Study Budgets to Meet Financial Objectives.
  • Develop Team Communications and Information for Research Department Meetings.
  • Maintain Compliance with Protocols Covering Patient Care and Clinical Trial Operations.
  • Recruit and Consent Study Participants.
  • Follow Informed Consent Processes and Maintained Records.
  • Create Recruitment Plan.
  • Screen Patient Records, Databases and Physician Referrals to Identify Prospective Candidates for Research Studies.
  • Monitor and Document Adverse Events.
  • Prepare and Submit SAE Forms.
  • Create Source Documents and CRFs for Investigator-Initiated Trials.
  • Perform Precise Data Collection and Data Entry Into Case Report Forms (CRF).
  • Maintain Temperature and Investigational Product Logs.
  • Prepare Investigational Product for Administration.
  • Track Study and Patient Payments.
  • Assist Physician with Publication Editing.
  • Assist with Marketing.
  • Collect, Evaluate, and Model Collected Data.
  • Gather, Process, and Ship Lab Specimens.
  • Coordinated clinical trials focused on disorders such as Atopic Dermatitis, Cosmetic Treatments, and Cyrolipolysis.
Clinical Research Coordinator, 02/2015 to 06/2018
Comprehensive Urologic Care – Lake Barrington, IL
  • Worked with Principal investigator and Sponsors to Facilitate Daily Trial Activities and Comply with Research Protocols on Eight Trials.
  • Recruited and Consented Study Participants.
  • Followed Informed Consent Processes and Maintained Records.
  • Screened Patient Records, Databases and Physician Referrals to Identify Prospective Candidates for Research Studies.
  • Monitor and Document Adverse Events.
  • Prepared Regulatory Submissions and Supporting Documents for IRB Review.
  • Performed Precise Data Collection and Data Entry Into Case Report Forms (CRF).
  • Collected Data and Followed Research Protocols, Operations Manuals and Case Report Form Requirements.
  • Negotiated and Complete Clinical Research Contracts and Budgets for Various Studies.
  • Prepared and Administered Investigational Product.
  • Maintained Temperature and Investigational Product Logs.
  • Tracked Study and Patient Payments.
  • Gathered, Processed and Shipped Lab Specimens.
  • Participated in Initiation Visits and Investigator Meetings, Implementing Trials in Accordance with Study Timelines and Budgets.
  • Coordinated clinical trials focused on disorders such as Bladder Cancer, Prostate Cancer, and Overactive Bladder.
Lead Certified Clinical Medical Assistant, 10/2013 to 02/2015
Comprehensive Urologic Care – Lake Barrington, IL
  • Managed All Correspondence for Physician.
  • Triaged Calls.
  • Oriented and Trained New Staff on Proper Procedures and Policies on Floor and on Computer Systems.
  • Assisted with Routine Office Procedures by Setting Up and Operating Special Medical Equipment and Apparatus.
  • Explained Procedures to Patients to Reduce Anxieties and Increase Patient Cooperation.
  • Assisted in Diagnostic Testing by Collecting and Processing Specimens.
  • Venipuncture.
  • Ordered Lab Testing, Schedule Procedures, and Call Patients with Test results.
  • Entered Information from Patient Visit into EMR.
  • Communicated Clearly and Effectively with Patients to Verify Information, Determine Purpose of Visit and Record Medical History.
  • Collected and Documented Patient Medical Information Such as Blood Pressure and Weight.
  • Obtained Client Medical History, Including Medication Information, Symptoms and Allergies.
  • Maintained Detailed Records of Test Results by Entering Data and Patient Information into Computer.
  • Sent Patient Prescriptions and Refills to Pharmacy.
  • Promoted Office Efficiency, Coordinating Charts, Completing Insurance Forms and Helping Patients with Diverse Needs.
  • Enhanced Patient Outcomes by Providing Knowledgeable Education on Procedures, Medications and Other Physician Instructions.
  • Scheduled Appointments, Registered Patients and Distributed Sample Pharmaceuticals as Prescribed.
Medical Assistant, 01/2013 to 03/2013
Mercy Health System, Externship – Woodstock, IL
  • Communicated clearly and effectively with patients to verify information, determine purpose of visit and record medical history.
  • Obtained client medical history, including medication information, symptoms and allergies.
  • Explained procedures to patients to reduce anxieties and increase patient cooperation.
  • Sanitized, restocked and organized exam rooms and medical equipment.
  • Conducted preliminary evaluations, including measuring weight, temperature and blood pressure, and documented results with accuracy.
  • Directed patients to exam rooms, fielded questions and prepared for physician examinations.
Education
Bachelor of Science: Health SciencePurdue University Global - Indianapolis, iN
CRC Basic Training Live: Clinical Research Coordinator Training, 09/2016
Northwestern University-NUCATS Institute - Chicago, IL
Certificate in Medical Assisting: Medical Assisting, 03/2013
First Institute - Crystal Lake, IL
  • Professional development completed in [Subject]
  • Coursework in [Subject], [Subject] and [Subject]
Affiliations

Society of Clinical Research Associates (SOCRA)

Model Agreements & Guidelines International (MAGI)

American Society for Laser Medicine and Surgery (ASLMS)

Trials Conducted

1. JOWL VOLUMA: A Randomized, Open-Label Study to Assess Jowl Improvement with Injectable Fillers: Jawline Injections alone vs Jawline and Cheek Injections (Investigator Initiated Trial).

2. GALDERMA: A Randomized, Double-Blind, Placebo-Controlled Study to Assess Immunization Responses in Adult and Adolescent Subjects with Moderate-to-Severe Atopic Dermatitis Treated with Nemolizumab.

3. VOLITE: A Randomized, Multicenter, Evaluator Blind, Controlled Study to Evaluate the Safety and Effectiveness of JUVEDERM VOLITE XC Injectable Gel for the Improvement of Cheek Skin Smoothness.

4. PREDICT: A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastesis in Patients with Castration-Resistant Prostate Cancer.

5. PERSPECTIVE; A Prospective, Non-interventional, Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder (OAB)

6. PRONOUNCE: A Multi-Center, Randomized, Assessor-Blind, Controlled Trial Comparing the Occurrence of Major Adverse Cardiovascular Events (MACEs) in Patients with Prostate Cancer and Cardiovascular Disease Receiving Degarelix (GnRH antagonist) or Leuprolide (LHRH agonist)

7. TRUMPET: A Prospective Observational Cohort Study of Patients with Castration-Resistant Prostate Cancer (CRPC) in the United States.

8. CONQUER: A Randomized, Multicenter, Two Arm, Randomized, Single Dose, Placebo-Controlled, Double-Blind, Phase 3 Study of Intravesical Qapzola (Apaziquone) as a Surgical Adjuvant in the Immediate Postoperative Period in Patients Undergoing Transurethral Resection for Non-Muscle Invasive Bladder Cancer.

9. VISTA: An Open Label, Muticenter, Phase 3 Study to Evaluate the Efficacy and Tolerability of Intravesical Vicinium in Subjects with Non-Muscle Invasive Carcinoma in Situ (CIS) and/or High Grade Papillary Disease of the Bladder Previously Treated with Bacillus Calmette-Guerin (BCG)

6. ENACT: A Randomized Study of Enzalutamide in Patients with Localized Prostate Cancer Undergoing Active Surveillance

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Resume Overview

Companies Worked For:

  • Advanced Dermatology
  • Comprehensive Urologic Care
  • Mercy Health System, Externship

School Attended

  • Purdue University Global
  • Northwestern University-NUCATS Institute
  • First Institute

Job Titles Held:

  • Clinical Research Coordinator
  • Lead Certified Clinical Medical Assistant
  • Medical Assistant

Degrees

  • Bachelor of Science : Health Science
    CRC Basic Training Live : Clinical Research Coordinator Training , 09/2016
    Certificate in Medical Assisting : Medical Assisting , 03/2013

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