Clinical Research Coordinator Resume Example
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.
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Beth Israel Deaconess Medical Center – Waltham , MA
- 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.
Beth Israel Deaconess Medical Center – Wayland , MA
- 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.
Wellpath – Middleton , MA
- 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.
Mercy Health System, Externship – City , STATE
- 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.
Northwestern University-NUCATS Institute - City
First Institute - City, State
- Professional development completed in [Subject]
- Coursework in [Subject], [Subject] and [Subject]
Society of Clinical Research Associates (SOCRA)
Model Agreements & Guidelines International (MAGI)
American Society for LaserMedicine and Surgery (ASLMS)
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
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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