Shalayna Woodly
Cincinnati,USA
Summary
Dynamic professional with extensive hands-on experience in Clinical Research, skilled at navigating challenges through a strategic mindset. Strong problem solver with a proactive approach to tasks, ensuring efficiency and effectiveness in all endeavors. Recognized for adaptability, creativity, and a results-oriented focus that consistently drives success. Demonstrates strong analytical, communication, and teamwork skills, with proven ability to quickly adapt to new environments. Committed to making meaningful contributions that advance organizational goals and foster growth while cultivating an environment of collaboration and innovation.
Overview
26
26
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator II
Cincinnati Children's Hospital and Medical Center - Heart Institute Research Core
12.2011 - Current
- Coordinated clinical trial activities and ensured compliance with regulatory requirements.
- Assisted in developing study protocols and informed consent documents for participant recruitment.
- Managed participant scheduling, including follow-up appointments and data collection sessions.
- Reviewed and maintained study documentation to ensure accuracy and completeness of records.
- Involved in screening, recruitment, and enrollment of research participants.
- Performed study start-up including database, data dictionary and database management plan creation, CRF design, IRB submissions of protocol, consent and study materials.
- Worked closely with Principal Investigators regarding project design, milestones and data quality deliverables.
- Implemented process improvements that streamlined data management workflows within research projects.
- Gathered, processed, and shipped lab specimens.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.
- Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
- Contributed to the successful completion of clinical trials by proactively resolving issues, mitigating risks, and meeting deadlines in a fast-paced environment.
- Coordinated for both NIH, Industry and In-House research studies.
- Performed all study responsibilities in accordance with GCP, IRB and SOP instructions.
CLERK II
12.2004 - 01.2011
- Provided administrative and clinical support to cardiologists and principal investigators.
- Developed and maintained databases for a variety of research projects.
Researcher
The Procter & Gamble Company - Corporate Technology Development, Personal Health Care
01.2000 - 01.2003
- Responsible for designing and developing technologies and product prototypes for new business ventures, e.g. pet waste containment systems, nutritionally fortified beverages, and hand cleansing products.
- Developed laboratory methods, formulated prototypes and conducted pilot scale evaluations of promising leads.
- Experienced with a range of research equipment including INSRTON, SEM, Extruder, Refractometer, HORIBA, Colorimeter, and Microfluidizer.
Turbine Airfoils Center of Excellence (TACoE)
General Electric Aircraft Engines - Aerospace Engineering Co-op
- Responsible for the redesign of an electronic data storage file system that included an integrated web-based format that lead to increased ease of access to the data. (1997)
CFM56 Engine Product Assembly
General Electric Aircraft Engines - Aerospace Engineering Co-op
- Responsible for redesigning part distribution kit carts that resulted in smoother engine assembly.
- Cooperatively worked with domestic and foreign employees to manage engine component supplies.
- Led an initiative to improve the proper disposal of defective parts that resulted in less defected parts on hand. (1998)
Large Commercial Engine Life Management
General Electric Aircraft Engines - Aerospace Engineering Co-op
- Responsible for determining stress concentration factors to establish the life values of LM2500 engine parts.
- Prepared critical feature reviews and documented life results.
- Utilized ANSYS for modeling of engine components. (1999)
Heat Transfer and Fluid Systems Design
General Electric Aircraft Engines - Aerospace Engineering Co-op
- Responsible for building and analyzing a 3D heat transfer model of a CF6 diffuser. The model was later used to troubleshoot a field cracking failure in that engine component. (1998)
Education
Aerospace Engineering
University of Cincinnati, College of Engineering
Cincinnati, OH06-1999
Instrumental and Vocal Music, Music Theater, and Drama
The School For The Creative And Performing Arts
Cincinnati, OH06-1996
Skills
- Supportive team-oriented mindset with the impact of cross-function teamwork and detail oriented support
- Microsoft Office proficient
- Database development via REDCap
- Skilled in EDC platforms including Medidata Rave, Bioclinica, INFORM, eClinical, Oracle Clinical One and REDCap
- Excellent communication and dependability, practiced multitasking, and expert critical thinking skills
- Active listening techniques combined with problem resolution to create a collaborative environment for colleagues and research study participants
- Adept in verbal communication, problem resolution, time management and leadership energy
Accomplishments
Association of Blood Pressure-Related Increase in Vascular Stiffness on Other Measures of Target Organ Damage in Youth.
Haley JE, Woodly SA, Daniels SR, Falkner B, Ferguson MA, Flynn JT, Hanevold CD, Hooper SR, Ingelfinger JR, Khoury PR, Lande MB, Martin LJ, Meyers KE, Mitsnefes M, Becker RC, Rosner BA, Samuels J, Tran AH, Urbina EM.
Hypertension. Author manuscript. 2022 Jun 28;79(9):2042-2050. doi: 10.1161/HYPERTENSIONAHA.121.18765. PMCID: PMC9378473
Associations Between Characteristics of Individuals With Fontan Circulation With Blood and Urine Biomarkers of Kidney Injury and Dysfunction.
Katz DA, Gao Z, Freytag J, Mahendran A, Szugye C, Woodly S, Alvarez TCE, Lubert AM, Alsaied T, Goldstein SL, Opotowsky AR.
J Am Heart Assoc. 2023 Jun 22;12(13):e029130. doi: 10.1161/JAHA.122.029130. PMCID: PMC10356073
Methylprednisolone for Heart Surgery in Infants - A Randomized, Controlled Trial.
Hill KD, Kannankeril PJ, Jacobs JP, Baldwin HS, Jacobs ML, O'Brien SM, Bichel DP, Graham EM, Blasiole B, Resheidat A, Husain AS, Kumar SR, Kirchner JL, Gallup DS, Turek JW, Bleiweis M, Mettler B, Benscoter A, Wald E, Karamlou T, Van Bergen AH, Overman D, Eghtesady P, Butts R, Kim JS, Scott JP, Anderson BR, Swartz MF, McConnell PI, Vener DF, Li JS; STRESS Network Investigators.
N Engl J Med. Author manuscript. 2022 Nov 6;387(23):2138-2149. doi: 10.1056/NEJMoa2212667. PMCID: PMC9843240
Woodly, S.A., Small, L.E., Mehansho, H., Krummen, R.W., Nunes, R.V.(2008). Compositions Comprising Protein and Fatty Acid (U.S. Patent No. 7393552-B2 ). U.S. Patent and Trademark Office.
Certification
Society of Clinical Research Coordinators (SOCRA) since 2017
Timeline
Clinical Research Coordinator II
Cincinnati Children's Hospital and Medical Center - Heart Institute Research Core
12.2011 - Current
CLERK II
12.2004 - 01.2011
Researcher
The Procter & Gamble Company - Corporate Technology Development, Personal Health Care
01.2000 - 01.2003
Turbine Airfoils Center of Excellence (TACoE)
General Electric Aircraft Engines - Aerospace Engineering Co-op
CFM56 Engine Product Assembly
General Electric Aircraft Engines - Aerospace Engineering Co-op
Large Commercial Engine Life Management
General Electric Aircraft Engines - Aerospace Engineering Co-op
Heat Transfer and Fluid Systems Design
General Electric Aircraft Engines - Aerospace Engineering Co-op
Aerospace Engineering
University of Cincinnati, College of Engineering
Instrumental and Vocal Music, Music Theater, and Drama
The School For The Creative And Performing Arts