Dedicated Clinical Research Coordinator experienced in complying with study protocols, standard operating procedures and good clinical practices. Practiced problem-solver with strong attention to detail. Prepared to offer [10] years' experience in the field and take on a fast-paced position.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Senior Clinical Research Coordinator
Science 37 (Remote)Contract
Culver City, CA
08.2023 - 01.2024
Monitored study progress and documented adverse events in accordance with protocol guidelines.
Coordinated patient visits, including scheduling appointments and collecting informed consent forms.
Trained new team members on the principles of Good Clinical Practice and ICH regulations.
Conducted pre-study site visits to assess compliance with protocols and applicable regulations.
Provided technical support to investigators regarding data entry into electronic case report forms.
Reviewed source documentation for accuracy of data entered into eCRFs.
Performed quality control checks on eCRF data by reviewing discrepancies reported by Data Management staff or generated from database queries.
Maintained accurate records of study documents including CRFs, informed consents, laboratory results.
Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
Placed orders for medications to be used in studies.
Senior Clinical Research Coordinator
Dermatology Treatment and Research Center
Dallas, TX
01.2023 - 08.2023
Adhered to standards in areas involving data collection, research protocols and regulatory reporting.
Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
Collected, processed and delivered specimens from trial participants.
Mentored and provided ongoing support to research team, providing training in research design and conduct.
Took vital signs and collected medical histories as part of study protocols.
Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
Monitored subject enrollment and tracked dropout details.
Senior Clinical Research Coordinator
Vault Health (Remote)
Coral Gables, FL
06.2022 - 10.2022
Mentored and provided ongoing support to research team, providing training in research design and conduct.
Gathered and reviewed study data.
Conducted screening interviews to determine eligibility of possible subjects.
Monitored subject enrollment and tracked dropout details.
Worked closely with team members to deliver project requirements, develop solutions and meet deadlines.
Decentralized trial working remotely and efficiently to provide sponsor clean data.
Clinical Research Coordinator
National Allergy and ENT
North Charleston, SC
04.2014 - 06.2022
Adhered to standards in areas involving data collection, research protocols and regulatory reporting.
Obtained informed consent of research subjects or guardians
Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
Organized, analyzed and modeled study data.
Collected, processed and delivered specimens from trial participants.
Managed clinical research trials involving Asthma, Atopic Dermatitis and Food Allergy disorders.
Checked electronic data capturing systems for integrity and compliance.
Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
Performed pre-study, closeout and interim visits to check on study activities.
Assessed drug storage conditions and procedures to check adherence to standard protocols.
Certified Medical Assistant
National Allergy & Asthma
North Charleston, SC
04.2010 - 03.2014
Relayed messages from patients to physicians about concerns, condition updates or refill requests to facilitate treatment.
Performed preliminary physical tests to accurately record results in patient history summary.
Prepared treatment rooms for patients by cleaning surfaces and restocking supplies.
Educated patients about medications, procedures and physician's instructions.
Interviewed patients to verify information, record medical history and confirm purpose of visit.
Contacted pharmacies to submit and refill patients' prescriptions.
Secured patient information and maintained patient confidence by completing and safeguarding medical records.
Assessed, documented and monitored vital signs for patients within outpatient setting.
Assisted with diagnostic testing by collecting and packaging biological specimens for internal and laboratory analysis.
Followed all principles of asepsis and infection control to meet patient safety guidelines.
Performed, validated and reported laboratory tests for prognosis, diagnosis, treatment and research.
Measured patient peak flows to improve workflow efficiency.
Education
Associate of Applied Science - Medical Assisting
Miller Motte College
North Charleston, SC
02.2010
High School Diploma -
Chino High School
Chino, CA
06.1992
Skills
10 years of clinical trial management experience including industry, investigator-initiated, and decentralized trials
Quality assurance support (data review/queries,study progress reports, and audits)
Adverse Event (AE, SAE), and protocol deviation management
Process improvement, database builds with IT programmers
Electronic Data Capture (EDC) and Trial Master File (TMF) maintenance, management, and user training
Development and completion of case report forms (eCRFs), SOPs, source documents, study protocols, informed consent forms (ICFs), and study logs
Coaching, supervising, mentoring, and project training experience
Phlebotomy, ECG,and Vital sign experience
Microsoft Office (Word, Excel, Powerpoint, Outlook,Teams)
Google Suite( Google drive, Gmail, Google meet, Google Sheets,Google Docs)