Carole Kringel, ACRC
Bradenton,Florida
Summary
Dedicated, Certified 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 several years' experience in the field and take on a fast-paced position.
Overview
25
25
years of professional experience
Work History
Clinical Research Coordinator
Sarasota Arthritis Centers
Sarasota
03.2025 - 01.2026
- 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.
- 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.
- 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 lnformed Consent.
- Educate participants on studies and anticipated outcomes.
- Experience with phlebotomy sample collection, processing & shipping; IATA certified.
- ICH-GCP certified.
Clinical Research Coordinator, Regulatory Coordinator
The Roskamp Institute
Bradenton
08.2021 - 03.2025
- Collaborated with Sponsors, Investigators, CROs to carry out efficient and fully compliant research trials.
- Adhered to standards in areas involving data collection, research protocols and regulatory reporting.
- Proficient in various tasks related to study start-up, site selection, initiation, recruitment, on-going coordination, and data management.
- Successfully managed (a) Alzheimer's and (1) Multiple Sclerosis Study, concurrently.
- Conducted screening and evaluations to determine eligibility of subjects for the PACT Trial- Preventing Alzheimer's Disease with Cognitive Training, USF Successful Aging Lab.
- Communicated 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.
- Completed IRB submissions, approvals, and renewals.
- Experienced in cognitive assessments relating to Neurological Disease & conditions.
- Conducted 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 lnformed Consent.
- Educated participants on studies and anticipated outcomes.
- Experience with phlebotomy sample collection, processing, and 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
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 and Performed study visits per Protocol, maintaining study timelines and metrics with efficiency and increase in patient enrollment into Intraocular Lens Survey Study with 100% increase in enrollment.
- Expert level experience with collection and Electronic Data Capture of study data with timely query resolution.
- Prepared and collaborated on budgets and implemented Clinical Trial Agreements (CTA/CDA) for multiple ophthalmic device and drug studies.
- Assisted in Protocol Synopsis and Protocol submission to sponsors, lRB, FDA for ophthalmic device and pharmaceutical studies including post market (FDA approved) studies.
- Developed a source document and Excel spreadsheet for data collection, leading to the primary investigator's 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, and post-op.
- Measurement & testing for use determining surgical options, lens implementation and superior outcomes.
Clinical Monitoring Associate II
PAREXEL International
San Diego
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, 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/CTA) including budget, site specific lnformed Consent Forms (lCF) and Source Documents.
- Collaborated on CSA including budget, IRB submissions and site specific ICF negotiations involving Clinical Trail Specialists (CTS).
- Collected, reviewed, and submitted site and study specific documents for lRB, EC and FDA.
- Followed up to secure IRB submission, approval, and renewal as required.
- Maintained 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
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
Bachelor of Science - Psychology, Chemistry
Florida State University
Tallahassee, FLAssociate of Arts - Biology, Pre-Med
Palm Beach State College
Lake Worth, FLSome College (No Degree) - Optometry
Southern College of Optometry
Memphis, TNSkills
- Trial management
- Specimen handling
- Informed consent
- Adverse event tracking
- Case report management
- Study protocols
- Good clinical practices
- Electronic data capture
- Patient recruitment
- Investigational product management
Affiliations
Phi Theta Kappa
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
Bachelor of Science - Psychology, Chemistry
Florida State University
Associate of Arts - Biology, Pre-Med
Palm Beach State College
Some College (No Degree) - Optometry
Southern College of Optometry