Clinical Research Coordinator Resume Example Advanced Dermatology

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

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

Clinical Research Coordinator Resume Example

Resume Score: 80%

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