Motivated Clinical Research Coordinator with experience in managing multiple studies, compliance to protocols and data management. Skills include team coordination, patient recruitment, data collection, analysis and reporting. Prior roles illustrated high standards of ethics while ensuring accuracy and quality in research outcomes.
Overview
18
18
years of professional experience
Work History
Clinical Research Coordinator III
University of Alabama at Birmingham
Birmingham, Alabama
12.2022 - Current
Manage all aspects of clinical trials as needed from study start-up through trial maintenance to study closure
Serves as a resource person within the area of clinical trial expertise
Train and mentor inexperienced staff on all clinical trial processes and procedures
Communicate with sponsors, PIs, Sub-Is, other departments, home health nurses, and patients acting as liaison between department and study
Develop protocol-specific systems and documents including process flows, training manuals, SOPs, and CRFs
Work effectively with contract, budget, finance, and regulatory to ensure proper budgeting, billing, and compliance for the trials coordinated by internal and external entities
Collect information to determine study feasibility and work with principal investigators to ensure proper trial oversight and data quality
Processing, shipping, and storage of samples; Order supplies and equipment; Coordinate shipping of supplies and equipment
Assist in conducting literature reviews and may contribute to assessing solutions for operational shortcomings of date procurement in protocol design
Assist in maintaining compliance with federal, state, and accrediting agencies (sponsors), including maintaining any required documentation
Conducts monitoring visit activities to ensure compliance with all clinical regulatory aspects of research
Directs recruitment enrollment, site and home visits include assessments of AEs and SAEs scheduling patient’s visits, addressing all queries form patients, and obtaining consent
Clinical Research Coordinator II
University of Alabama at Birmingham
Birmingham, Alabama
02.2021 - 12.2022
Managed all aspects of assigned clinical studies including education
Performed all tasks relevant to study participant selection, including written consent, screening, and educating subjects caregivers, and referral sources on protocol specific details and expectations
Collaborated with sponsors/CROs to create IRB submissions, revisions, and consent material
Submitted applications and revisions for research studies, make amendments to protocols and weekly progress reports
Reported on progress of research programs to IRB, project team, and division
Collected data on research progress, adverse reactions, deviations and results
Ensured regulatory compliance, maintain policy records and procedure materials
Recruited and interviewed study participants; arrange patient visits; Coordinated with study partners to ensure recruitment goals are met
Trained and mentored incoming staff on open research protocols and study procedures
Prepared sponsor files for FDA compliance and GCP guidelines
Created source documents, maintain reports, and meet with monitors on routine site visits
Gathered, processed, and shipped lab specimens
Ordered supplies and equipment, coordinate shipping of supplies and equipment
Maintained a central calendar for tracking study timelines and milestones
Administered payments to participants at study milestones following study procedures
Front Office Coordinator
Brookwood Baptist Health
Alabaster, Alabama
10.2019 - 02.2021
Developed and implemented office management procedures, increasing training efficiency, team productivity and accuracy
Greeted members and patients upon arrival, registered all patients at each visit, verified all patient and insurance information
Established and updated work schedules to account for changing staff levels and expected workloads
Managed filing systems for electronic and hard copy documents to keep organized records
Maintained accurate, current and compliant financial records by monitoring and addressing variances
Managed scheduling, travel arrangements, communication screenings and other administrative support tasks for administrative personnel
Helped employees with day-to-day work and complex problems by applying motivational and analytical strategies
Established positive working relationships with colleagues, managers and customers through regular communication and effective anticipation of needs
Produced highly accurate internal and external letters and memoranda
Managed office supply orders and inventory
Clinical Trials Specialist
University of Alabama at Birmingham
Birmingham, Alabama
09.2017 - 09.2019
Prepared, submitted, and assisted with multiple levels of research documentation related to IRB submissions to UAB and WIRB
Maintained compliance with protocols covering patient care and clinical trial operations
Coordinated clinical trials focused on disorders such as Diabetes and Growth Hormone Deficiency
Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets
Worked with 6-7 principal investigators and multiple sponsors to facilitate daily trial activities and comply with research protocols
Monitored unit budget to meet financial objectives for spend rate and funding
Followed informed consent processes and maintained records
Collected data and followed research protocols, operations manuals, and case report form requirements
Screened patient records, databases, and physician referrals to identify prospective candidates for research studies
Gathered, processed, and shipped lab specimens
Conducted day-day-day duties accurately and efficiently
Research Specialist
University of Alabama at Birmingham
Birmingham, Alabama
07.2014 - 08.2017
Provided support in recruiting, screening, enrolling, and scheduling clinical trial subjects
Conducted study visits, informed consent, data collection, blood drawings, specimen collection and completed case forms for trial participants
Collaborated with sponsors, grants, and contract administrators to complete negotiation of clinical trial agreements, amendments, budgets, and invoicing
Completed and submitted UAB extramural Checklists, Expedited Checklists, no-cost extensions, renewals, and subject incentive debit card applications
Assisted with grant submission, tracking via OCGA E-Reports Assisting principal investigators and/or members of research team with protocols, budgets, and plans for clinical research studies
Analyzed variations in complex tests, experiments, and procedures to produce research data
Guided technical programs and administrative activities in research settings and integrated quality assurance and safety programs
Patient Account Representative
University of Alabama Health Services Foundation, I - Previewer
Birmingham, Alabama
07.2010 - 07.2014
Verified insurance coverage and interacted with network providers and health plans to manage customer expectation obtained precertification and referrals for clinic visits posted all related information to billing system updated account information in billing system and met daily turnover criteria contacted parents if necessary for insurance information followed up with PMP and/or insurance company for delayed referrals
Prepared reports detailing billing actions, flags, and other key information
Utilized computer programs to create invoices, letters, and other documents
Administrative Office Specialist
University of Alabama Health Services Foundation
Birmingham, Alabama
12.2006 - 07.2010
Assisted in answering 5-6 phone lines; Schedule and reschedule patient appointments
Managed clinic templates and calendars for 5 physicians; Scanning and importing documents into electronic medical records; Transcription, correction, printing, and mailing of dictated reports Maintain new patient data base
Coached staff on daily performance and conducted evaluations to constructively address concerns
Collected, arranged and input information into database system
Education
BS - Management
Amridge University
Montgomery, Al
12.2021
High School Diploma -
Southside High School
Selma, Al
05.2001
Skills
Leadership and Compliance
Problem solving
Trial management
Informed consent
Protocol development
Study protocols
Specimen collections
Research experience
Report preparation
Study monitoring
Clinical trial management
Subject retention strategies
Patient recruitment
Clinical research ethics
Timeline
Clinical Research Coordinator III
University of Alabama at Birmingham
12.2022 - Current
Clinical Research Coordinator II
University of Alabama at Birmingham
02.2021 - 12.2022
Front Office Coordinator
Brookwood Baptist Health
10.2019 - 02.2021
Clinical Trials Specialist
University of Alabama at Birmingham
09.2017 - 09.2019
Research Specialist
University of Alabama at Birmingham
07.2014 - 08.2017
Patient Account Representative
University of Alabama Health Services Foundation, I - Previewer
07.2010 - 07.2014
Administrative Office Specialist
University of Alabama Health Services Foundation
12.2006 - 07.2010
BS - Management
Amridge University
High School Diploma -
Southside High School
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