Daniel E. Kuraska
North Charleston,SC
Summary
Versatile clinical research professional knowledgeable about coordinating patient information, laboratory samples and compliance documents for diverse clinical trials. Highly organized and thorough with good planning and problem-solving abilities. Certified in GCP and IATA
Overview
7
7
years of professional experience
Work History
Primary research
- Coordinator for a research grant
- Purpose: Collect quantitative data from eligible cochlear implant recipients.
- Performed statistical, qualitative, and quantitative analysis
Clinical Research Coordinator II
Sarah Cannon Research Institute/HCA Healthcare
11.2022 - 06.2023
- Perform routine operational activities for multiple research protocols
- Ensure the integrity of the data submitted on Case Report Forms or other data collection tools by careful source document review; monitor data for missing or implausible data
- Collect, complete, and enter data into study specific case report forms or electronic data capture systems
- Collaborate closely with various site departments/teams, including finance, relevant hospital administrative representatives, and the local IRB, if applicable
- Review the study design and inclusion/exclusion criteria with physician and patient
Study Activation Specialist
Sarah Cannon Research Institute/HCA Healthcare
05.2022 - 11.2022
- Perform Clinical Trial Site Activation activities that include initiation and coordination of activities and essential document management during the study start-up; responsible for compiling Investigator Initiation Package (IIP)
- Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines are not reached: investigates and provides clear rationale for delays, provides support on contingency plan to mitigate impact, and escalates the issue as soon as identified
- Develop relationships with sponsors and contract research organizations (CROs), which provide potential studies
Clinical Research Specialist
Medical University of South Carolina
05.2020 - 10.2020
Clinical Research Coordinator
Articularis Healthcare
10.2020 - 05.2020
- Implement a variety of patient recruitment strategies to successfully meet study accrual goals
- Screen all patients that have been newly diagnosed, have progressed, or experienced a recurrence for possible inclusion into an active clinical trial
- Inform eligible patients on study specifics, obtain informed consent, thoroughly go through inclusion/exclusion criteria and coordinate protocol specific assessments and procedures including phlebotomy, EKGs, and vital signs
- Timely and accurately collect and submit data into sponsor specific eCRF databases; address any applicable queries and provide solutions and preventative action plans for protocol deviations
Clinical Research Coordinator
Dermatology, Clinical Research Center of the Carolinas, Dermatology
02.2019 - 03.2020
- Assisting with audits, maintaining study binders/reg documents, coordinating study start up and close out and attending SIV’s
- Dispense investigational product to enrolled study subjects via IWRS systems and perform drug accountability when required per protocol
- Perform the following using proper technique; phlebotomy, peripheral blood smears, skin microbiome swab analysis, proper processing of collected blood samples according to IATA guidelines
Clinical Research Coordinator
Malignant Hematology, MUSC Hollings Cancer Center
07.2018 - 01.2019
- Timely and accurately submit serious adverse events to sponsor, IRB, and DSMC per institutional guidelines
- Attend weekly tumor board meetings in order collaborate with treating physicians and determine the best possible oncology treatment plan for each patient including potential enrollment on the sites enrolling studies
- Perform investigational product accountability as well as PK collection per study protocols
Health Information Associate/Patient Coordinator
Whittingham Cancer Center
11.2016 - 06.2018
- Release of medical records upon the request of external providers for continuity of patient care and proper filing of reports for physician review in a timely manner using Cerner EMR software
- Responsible for new patient coordination by obtaining and analyzing all necessary medical records relevant to the diagnosis of the patient from referring physician offices, determining the urgency of treatment and scheduling consults accordingly with the correct specialty physician(s)
- Maintain a strong understanding of HIPAA compliance regulations, oncology/hematology terminology and diagnostic testing procedures that correspond to each diagnosis
- Completed EHR audit quality maintenance procedures, processed chart requests, facilitated chart purges and organized medical record copy requests
Education
CPR and AED Certified, American Red Cross ICH GCP and IATA (Biological Substances, Category B -
Bachelor of Science - Public Health
Southern Connecticut State University
New Haven, CT05.2016
Skills
- Detail Oriented
- Data Analysis
- Electronic Data Capture (EDC)
- Critical thinking
- Clinical Development
- Organized
Accomplishments
- EXPERIENCE AND DELEGATION WITH THE FOLLOWING CLINICAL TRIALS: (including but not limited to)
- A Multi Center, Randomized, Double-Blind, Placebo-and Active Comparator-Controlled Phase III Study to Evaluate the
- Efficacy and Safety of BMS-986165 in Subjects with Moderate-to-Severe Plaque Psoriasis
- Phase II evaluation of safety, tolerability, and efficacy of BI 730357 in patients with moderate-to-severe plaque psoriasis
- A phase III Efficacy and Safety Study of Tapinarof for the Treatment of Plaque Psoriasis in Adults
- A randomized, double blind, vehicle-controlled multicenter phase III study to evaluate the safety and efficacy of BF-200 ALA (Ameluz) and BF-RhodoLED in the treatment of superficial basal cell carcinoma (sBCC) with photodynamic therapy (PDT)
- A phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study Of The Efficacy And Safety Of Apremalist (CC10004) In Subjects With Mild To Moderate Plaque Psoriasis
- A randomized, double-blind, multicenter study assessing short (16 weeks) and long-term efficacy (up to 1 year), safety, and tolerability of 2 subcutaneous Secukinumab dose regimens in adult patients with moderate to severe hidradenitis suppurativa (SUNSHINE)
- A Phase III, 8-Week, Parallel Group, Double Blind, Vehicle Controlled Study of the Safety and Efficacy of ARQ-151 Cream3% Administered QD in Subjects with Chronic Plaque Psoriasis
- A Single Center, Open-Label Pilot Study to Evaluate the Safety and Efficacy of DT Skin Lightener in Subjects with Melasma
- A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and
- Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants with Diffuse Large B-Cell Lymphoma
- Phase 2 study of Acalabrutinib in ibrutinib (IBR)-intolerant patients (pts) with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)
- A Phase 1/2 A Open-Label, Multi-Dose, Multi-Center Escalation and Exploratory Study of Cerdulatinib (PRT06207) in
- Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) or B-Cell or T-
- Cell Non-Hodgkin Lymphoma (NHL) A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy and Safety Study of Methotrexate to Increase Response Rates in Patients with Uncontrolled Gout Receiving KRYSTEXXA (pegloticase) (MIRROR Randomized Controlled Trial [RCT])
- Eli Lilly and Company/ A randomized, Controlled Pragmatic Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid
- Arthritis
- A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib
- Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib
- Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis
- Scipher Medicine Corporation Study to Accelerate Information of Molecular Signatures (AIMS) in Rheumatoid Arthritis
Timeline
Clinical Research Coordinator II
Sarah Cannon Research Institute/HCA Healthcare
11.2022 - 06.2023
Study Activation Specialist
Sarah Cannon Research Institute/HCA Healthcare
05.2022 - 11.2022
Clinical Research Coordinator
Articularis Healthcare
10.2020 - 05.2020
Clinical Research Specialist
Medical University of South Carolina
05.2020 - 10.2020
Clinical Research Coordinator
Dermatology, Clinical Research Center of the Carolinas, Dermatology
02.2019 - 03.2020
Clinical Research Coordinator
Malignant Hematology, MUSC Hollings Cancer Center
07.2018 - 01.2019
Health Information Associate/Patient Coordinator
Whittingham Cancer Center
11.2016 - 06.2018
Primary research
CPR and AED Certified, American Red Cross ICH GCP and IATA (Biological Substances, Category B -
Bachelor of Science - Public Health
Southern Connecticut State University