Carole Kringel
Clinical Research Coordinator
Bradenton,USA
Summary
Dedicated and accomplished Clinical Research Coordinator and Clinical Monitoring Associate background with over 20 years of clinical and research experience to include Ophthalmology, Neurology, Arthritis/Autoimmune Disease & Oncology.
Overview
25
25
years of professional experience
Work History
Clinical Research Coordinator
Sarasota Arthritis Centers
Sarasota, FL
03.2025 - 01.2026
- Coordinated clinical trial activities, ensuring compliance with regulatory guidelines and protocols.
- Collaborate with Sponsors, Investigators, CROs to carry out efficient and fully compliant research trials.
- Managed patient recruitment processes, enhancing participant engagement and retention rates.
- Expert level with data collection, electronic data capture, management to include, but not limited to Veeva, Rave, RedCap, ensuring accuracy and timely reporting of results.
- Successfully managed (2) Psoriatic Arthritis, (1) GCA and (4) Sjorgren's studies concurrently.
- Extensive experience developing Source Documents, design, preparation, modification and implementation.
- ICH-GCP certified.
- Phlebotomy experience, sample collection, processing & shipping. IATA certified.
Clinical Research Coordinator, Regulatory Coordinator
The Roskamp Institute
Bradenton, FL
08.2021 - 03.2025
- Collaborate with Sponsors, Investigators, CROs to carry out efficient and fully compliant research trials.
- Adhere to standards in areas involving data collection, research protocols and regulatory reporting.
- Proficient in the various tasks related to study start-up, site selection, initiation, recruitment, on-going coordination, and data management.
- Successfully managing (4) Alzheimer’s and (1) Multiple Sclerosis Study, concurrently.
- Conduct screening and evaluations to determine eligibility of subjects for the PACT Trial – Preventing Alzheimer’s Disease with Cognitive Training, USF Successful Aging Lab.
- Communicate effectively and efficiently with Investigators, study staff, Sponsors, vendors, IRB personnel and other stakeholders throughout the life cycle of trials.
- Extensive experience with Source Document design, preparation, modification, and implementation.
- Complete IRB submissions, approvals, and renewals.
- Experience in cognitive assessments relating to Neurological Disease & conditions.
- Conduct screening interviews and evaluations to determine eligibility of possible subjects.
- Responsible for set-up and maintenance of Trial Master Files, Subject & Regulatory Binders.
- Qualified to implement Informed Consent.
- Educated participants on studies and anticipated outcomes.
- Experience with phlebotomy sample collection, processing & shipping; IATA certified.
- ICH-GCP certified.
- Montreal Cognitive Assessment (MoCA), Mini-Mental State Examination (MMSE) & CSSRS certified rater.
Clinical Research Coordinator, Certified Ophthalmic Technician
The Eye Associates
Bradenton, FL
02.2017 - 08.2021
- Conducted clinical trials according to Sponsor, Investigator, CRO and Protocol specifications under ICH-GCP, IRB and FDA guidelines.
- Collected and captured data onto Source Documents and into EDC for multiple study modalities: Intraocular pressure control drugs (Glaucoma), Ocular anti-inflammatories, Dry Eye relief, Drug delivery methods & systems for ocular anti-inflammatories, Macular Degeneration and Glaucoma medications, Intraocular Lens Implants (Cataracts & Refractive Errors).
- Responsible for over 100% increase in patient enrollment into Intraocular Lens Survey Study.
- Performed study visits per Protocol, maintaining study timelines and metrics with efficiency and accuracy.
- Expert level experience with collection and Electronic Data Capture of study data with timely query resolution.
- Prepared and collaborated on budgets and implementing Clinical Trial Agreements (CTA/CDA) for multiple ophthalmic device and drug studies.
- Assisted in Protocol Synopsis and Protocol submission to sponsors, IRB, FDA for ophthalmic device and pharmaceutical studies including post market (FDA approved) studies.
- Developed Source Document and Excel Spreadsheet for data collection leading to Primary Investigator medical journal publication and Pharmaceutical/Device continued data support.
- Efficient handling of patients & quality care and evaluations for multiple specialties in Ophthalmology to include examinations, testing, pre-op & post-op.
- Measurement & testing for use determining surgical options, lens implantation and superior outcomes.
Clinical Monitoring Associate II
PAREXEL International
San Diego, CA
01.2016 - 10.2016
- Responsible for conducting and facilitating specific study start-up activities, site selection and patient selection/enrollment from initiation to patient enrollment for Oncology study leading to drug approval and availability in Europe and Japan.
- Built collaborative relationships with Sponsors, Principal Investigators, Parexel staff and site staff.
- Functioned as Parexel’s remote contact/liaison with multiple assigned clinical sites.
- Compiled Site Regulatory Package (SRP) for review and approval.
- Submitted and followed up with sites on Clinical Site Agreements (CSA) including budget, site specific Informed Consent Forms (ICF) and Source Documents.
- Collaborated on CSA including budget, IRB submissions and site specific ICF negotiations involving Clinical Trial Specialists (CTS).
- Collected, reviewed, and submitted site and study specific documents for IRB, EC and FDA.
- Followed up to secure IRB submission, approval and renewal as required.
- Maintained a complete understanding of the various tasks related to study start-up, site selection and initiation, recruitment, and on-going monitoring processes.
- Prepared and maintained Trial Master File.
Certified Ophthalmic Technician, Study Coordinator, Sub-Investigator, Surgical Assistant
Gordon Schanzlin Vision Institute
San Diego, CA
02.2001 - 12.2015
- Efficiently and thoroughly handled patient consults for all types of ophthalmic care and Refractive, Cataract and Clear Lens Exchange procedures including both pre and post op evaluations, testing and instruction.
- Coordinated and participated in Clinical Trials: Refocus, Cross-linking, Topo-Guided Laser Treatment, Presbia, Femtosecond Laser for LASIK flap.
- Provided surgical assistance for all types of Refractive, Cataract and other office procedures.
- Expertly performed comprehensive ophthalmic exams, including visual acuity, refraction, intraocular pressure measurements and slit lamp biomicroscopy.
- Proficient in data entry, electronic medical records, Nextech.
Education
Some College (No Degree) - Optometry
Southern College of Optometry
Memphis, TNBachelor of Science - Psychology, Chemistry
Florida State University
Tallahassee, FLAssociate of Arts - Biology, Pre-Optometry
Palm Beach State College
Lake Worth, FLSkills
- Clinical Research Coordinator
- Clinical Monitoring Associate
- Certified Ophthalmic Technician
- ICH-GCP and HIPPA Certified
- MoCA, MMSE & CSSRS Certified Rater
- Exemplary Communication skills - verbal and written; Word and Excel proficient
- Extensive experience with multiple Electronic Data Capture platforms - Veeva, Rave, RedCap, Inform, Clario
- Surgical Assistant
- Languages: English proficient, Spanish conversational
LANGUAGES
English
Spanish
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Clinical Research Coordinator
Sarasota Arthritis Centers
03.2025 - 01.2026
Clinical Research Coordinator, Regulatory Coordinator
The Roskamp Institute
08.2021 - 03.2025
Clinical Research Coordinator, Certified Ophthalmic Technician
The Eye Associates
02.2017 - 08.2021
Clinical Monitoring Associate II
PAREXEL International
01.2016 - 10.2016
Certified Ophthalmic Technician, Study Coordinator, Sub-Investigator, Surgical Assistant
Gordon Schanzlin Vision Institute
02.2001 - 12.2015
Associate of Arts - Biology, Pre-Optometry
Palm Beach State College
Some College (No Degree) - Optometry
Southern College of Optometry
Bachelor of Science - Psychology, Chemistry
Florida State University