Deborah Branigan
Portland,OR
Summary
Dynamic Clinical Research Associate with expertise in FDA regulations and ICH guidelines. Proven ability to ensure subject safety and data integrity while managing complex multi-site studies. Strong coordination and creative problem-solving skills drive successful trial outcomes in diabetes drug and device studies. Committed to excellence in clinical research and regulatory compliance. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Pursuing full-time role in clinical trial monitoring that presents professional challenges and leverages interpersonal skills, effective time management, and problem-solving expertise.
Overview
24
24
years of professional experience
1
1
Certification
5
5
years of post-secondary education
Work History
Clinical Research Associate
Oregon Health & Sciences University
11.2013 - Current
- Monitor the conduct of clinical trials, especially enrollment and quality of data.
- Verify subject safety and site adherence to FDA Regulations and ICH/GCP Guidelines.
- Ensure Adverse Events are reported appropriately, accurately and in a timely manner and that follow-up activities are conducted as necessary.
- Review CRF, Informed Consent Documents and query language/narratives.
- Acquire specific clinical and therapeutic knowledge related to studies monitored.
- Conduct Qualification, Initiation, Interim and Closeout monitoring visits for multi-site studies.
- Ensure complete and thorough study drug reconciliation.
- Manage trip reports, letters, query resolutions and expenses.
- Manage site master file contents and work with sites to ensure communication requirements between site and IRB are adhered to.
- Provide support and timely follow-up for all audit and quality assurance activities.
Research Assistant III Lead
Legacy Research Institute
11.2006 - 11.2013
- Oversee all clinical research coordinators
- Monitor the conduct of clinical trials, especially enrollment and quality of data.
- Verify subject safety and site adherence to FDA Regulations and ICH/GCP Guidelines.
- Ensure Adverse Events are reported appropriately, accurately and in a timely manner and that follow-up activities are conducted as necessary.
- Review CRF, Informed Consent Documents and query language/narratives.
- Acquire specific clinical and therapeutic knowledge related to studies monitored.
- Provide support and timely follow-up for all audit and quality assurance activities.
- Participated actively in regular meetings with fellow researchers to discuss project updates, challenges faced, and lessons learned during ongoing activities.
- Monitored project timelines, ensuring timely completion of tasks while maintaining high-quality output.
Quality Control Technician
Ceva Biomune
05.2001 - 11.2006
- Prepared/maintained all primary, secondary and cell line cultures.
- Performed virus titration, virus neutralizations, ELISAS, and bacterial assays.
- Performed immunofluorescence assays daily to determine viral potency.
- Served as the lead for all quality control testing of Marek’s vaccine.
- Training new technicians, sharing knowledge, best practices, and improving team performance as a whole.
Education
Bachelor of Arts - Chemistry And Biology Education
University of Northern Iowa
Cedar Falls, IA 09.1995 - 05.2000
Skills
- Ethics in Clinical Research
- International Conference on Harmonization Guidelines
- Requirements for FDA regulated drug and device studies
- Health Insurance Portability and Accountability Act
- 15 years experience in writing and managing investigational device exemptions for our diabetes device development group
- Manage DSMB including preparing reports and running open sessions
- Oversee all clinical research coordinators creating a smooth workflow to allow everyone to work effectively as a team
- Monitoring:- Pre-study, Site Initiation, Interim Visit and Close-Out
- Diabetes Clinical Trials
- Reporting and Documentation
- Creative Problem Solving
- Interpersonal and Communication Skills
- Multi-Task Management
- Project Management
Accomplishments
- 15 years experience in clinical trial management and monitoring of single and multi-site investigator initiated trials
- Deep knowledge of monitoring procedures.
- Detailed knowledge of GCP and ICH guidelines including basic understanding of regulatory requirements.
- Excellent knowledge of clinical trial process.
- Comprehensive knowledge of clinical practices, clinical trial monitoring and design controls
- Familiar with the practices and methods of clinical trial methodology and research
- Extensive knowledge of clinical trial management systems as well as the design and implementation of clinical plans
- Strong communication, good interpersonal, organizational, and management skills
- Excellent attention to detail and diverse cultural awareness
Certification
- SOCRA Certification CCRP October 2014
Journals
2023
Jacobs, P.G., Resalat N., Hilts W., Young G., Leitschuh, J., Pinsonault, J., El Youssef, J., Branigan, D., Gabo, V., Eom, J., Ramsey, K., Dodier, R., Mosquera-Lopez, C., Wilson, L., Castle, J.R. Integrating metabolic expenditure information from wearable fitness sensors into an AI-augmented automated insulin delivery system: a randomised clinical trial. Lancet. Vol 5, Issue 9, E607-E617 (2023). https://doi.org/10.1016/S2589-7500(23)00112-7
2023
Gavin M Young, Peter G Jacobs, Nichole S Tyler, Thanh-Tin P Nguyen, Jessica R Castle, Leah M Wilson, Deborah Branigan, Virginia Gabo, Florian H Guillot, Michael C Riddell, Joseph El Youssef. Quantifying insulin-mediated and noninsulin-mediated changes in glucose dynamics during resistance exercise in type 1 diabetes. American Journal Physiology-Endocrinology Metabolism Vol 325, Issue 3, E192-E206 (08AUG2023). https://doi.org/10.1152/ajpendo.00298.2022
2023
Mosquera-Lopez, C., Wilson, L.M., El Youssef, J., Hilts W., Leitschuh, J., Branigan, D., Gabo, V., Eom, J., Castle, J.R., Jacobs, P.G. Enabling fully automated insulin delivery through meal detection and size estimation using Artificial Intelligence. npj Digit. Med. 6, 39 (2023). https://doi.org/10.1038/s41746-023-00783-1
2022
Jessica R. Castle, Leah M. Wilson, Nichole S. Tyler, Alejandro Z. Espinoza, Clara M. Mosquera-Lopez, Taisa Kushner, Gavin M. Young, Joseph Pinsonault, Robert H. Dodier, Wade W. Hilts, Sos M. Oganessian, Deborah L. Branigan, Virginia B. Gabo, Jae H. Eom, Katrina Ramsey, Joseph El Youssef, Joseph A. Cafazzo, Kerri Winters-Stone and Peter G. Jacobs. Assessment of a Decision Support System for Adults with Type 1 Diabetes on Multiple Daily Insulin Injections. Diab Tech & Ther.2022 Nov 25; 24(12): 892-897. https://doi.org/10.1089/dia.2022.0252
2020
Wilson LM, Jacobs PG, Ramsey KL, Resalat N, Reddy R, Branigan D, Leitschuh J, Gabo V, Guillot F, Senf B, El Youssef J, Steineck IIK, Tyler NS, Castle JR. Dual-Hormone Closed-Loop System Using a Liquid Stable Glucagon Formulation Versus Insulin-Only Closed-Loop System Compared With a Predictive Low Glucose Suspend System: An Open-Label, Outpatient, Single-Center, Crossover, Randomized Controlled Trial. Diabetes Care. 2020 Nov;43(11):2721-2729. doi: 10.2337/dc19-2267. Epub 2020 Sep 9. PubMed PMID: 32907828.
2020
Guillot FH, Jacobs PG, Wilson LM, Youssef JE, Gabo VB, Branigan DL, Tyler NS, Ramsey K, Riddell MC, Castle JR. Accuracy of the Dexcom G6 Glucose Sensor during Aerobic, Resistance, and Interval Exercise in Adults with Type 1 Diabetes. Biosensors (Basel). 2020 Sep 29;10(10). doi: 10.3390/bios10100138. PubMed PMID: 33003524; PubMed Central PMCID: PMC7600074.
2020
Jacobs PG, Tyler NS, Vanderwerf SM, Mosquera-Lopez C, Seidl T, Cargill R, Branigan D, Ramsey K, Morris K, Benware S, Ward WK, Castle JR. Measuring glucose at the site of insulin delivery with a redox-mediated sensor. Biosens Bioelectron. 2020 Oct 1;165:112221. doi: 10.1016/j.bios.2020.112221. Epub 2020 Apr 29. PubMed PMID: 32729464.
2020
Tyler NS, Mosquera-Lopez CM, Wilson LM, Dodier RH, Branigan DL, Gabo VB, Guillot FH, Hilts WW, El Youssef J, Castle JR, Jacobs PG. An artificial intelligence decision support system for the management of type 1 diabetes. Nat Metab. 2020 Jul;2(7):612-619. doi: 10.1038/s42255-020-0212-y. Epub 2020 Jun 1. PubMed PMID: 32694787; PubMed Central PMCID: PMC7384292.
2019
Tyler NS, Mosquera-Lopez CM, Wilson LM, Resalat N, Dodier R, Branigan D, et al. 1051-P: Improving Glycemic Outcomes in T1D Using an Automated Decision Support Recommender System: Evaluation In Silico and Compared with Physician Recommendations. Diabetes 2019;68:1051-P. doi:10.2337/db19-1051https://diabetes.diabetesjournals.org/content/68/Supplement_1/1051-P.abstract
2018
Castle JR, El Youssef J, Wilson LM, Reddy R, Resalat N, Branigan D, Ramsey K, Leitschuh J, Rajhbeharrysingh U, Senf B, Sugerman SM, Gabo V, Jacobs PG. Randomized Outpatient Trial of Single- and Dual-Hormone Closed-Loop Systems That Adapt to Exercise Using Wearable Sensors. Diabetes Care. 2018 Jul;41(7):1471-1477. doi: 10.2337/dc18-0228. Epub 2018 May 11. PubMed PMID: 29752345; PubMed Central PMCID: PMC6014543.
2018
Reddy R, El Youssef J, Winters-Stone K, Branigan D, Leitschuh J, Castle J, Jacobs PG. The effect of exercise on sleep in adults with type 1 diabetes. Diabetes Obes Metab. 2018 Feb;20(2):443-447. doi: 10.1111/dom.13065. Epub 2017 Sep 14. PubMed PMID: 28718987; PubMed Central PMCID: PMC6314304
2016
Jacobs PG, El Youssef J, Reddy R, Resalat N, Branigan D, Condon J, Preiser N, Ramsey K, Jones M, Edwards C, Kuehl K, Leitschuh J, Rajhbeharrysingh U, Castle JR. Randomized trial of a dual-hormone artificial pancreas with dosing adjustment during exercise compared with no adjustment and sensor-augmented pump therapy. Diabetes Obes Metab. 2016 Nov;18(11):1110-1119. doi: 10.1111/dom.12707. Epub 2016 Aug 15. PubMed PMID: 27333970; PubMed Central PMCID: PMC5056819.
2016
Castle JR, Youssef JE, Branigan D, Newswanger B, Strange P, Cummins M, Shi L, Prestrelski S. Comparative Pharmacokinetic/Pharmacodynamic Study of Liquid Stable Glucagon Versus Lyophilized Glucagon in Type 1 Diabetes Subjects. J Diabetes Sci Technol. 2016 Sep;10(5):1101-7. doi: 10.1177/1932296816653141. Print 2016 Sep. PubMed PMID: 27325390; PubMed Central PMCID: PMC5032962.
2015
Castle JR, El Youssef J, Bakhtiani PA, Cai Y, Stobbe JM, Branigan D, Ramsey K, Jacobs P, Reddy R, Woods M, Ward WK. Effect of Repeated Glucagon Doses on Hepatic Glycogen in Type 1 Diabetes: Implications for a Bihormonal Closed-Loop System. Diabetes Care. 2015 Nov;38(11):2115-9. doi: 10.2337/dc15-0754. Epub 2015 Sep 4. PubMed PMID: 26341131; PubMed Central PMCID: PMC4613914.
2015
Jacobs PG, Resalat N, El Youssef J, Reddy R, Branigan D, Preiser N, Condon J, Castle J. Incorporating an Exercise Detection, Grading, and Hormone Dosing Algorithm Into the Artificial Pancreas Using Accelerometry and Heart Rate. J Diabetes Sci Technol. 2015 Oct 5;9(6):1175-84. doi: 10.1177/1932296815609371. PubMed PMID: 26438720; PubMed Central PMCID: PMC4667295.
2015
Leng TD, Li MH, Shen JF, Liu ML, Li XB, Sun HW, Branigan D, Zeng Z, Si HF, Li J, Chen J, Xiong ZG. Suppression of TRPM7 inhibits proliferation, migration, and invasion of malignant human glioma cells. CNS Neurosci Ther. 2015 Mar;21(3):252-61. doi: 10.1111/cns.12354. Epub 2014 Dec 1. PubMed PMID: 25438992; PubMed Central PMCID: PMC4339490.
2015
Bakhtiani PA, El Youssef J, Duell AK, Branigan DL, Jacobs PG, Lasarev MR, Castle JR, Ward WK. Factors affecting the success of glucagon delivered during an automated closed-loop system in type 1 diabetes. J Diabetes Complications. 2015 Jan-Feb;29(1):93-8. doi: 10.1016/j.jdiacomp.2014.09.001. Epub 2014 Sep 16. PubMed PMID: 25264232; PubMed Central PMCID: PMC4281277.
2014
Jacobs PG, El Youssef J, Castle J, Bakhtiani P, Branigan D, Breen M, Bauer D, Preiser N, Leonard G, Stonex T, Ward WK. Automated control of an adaptive bihormonal, dual-sensor artificial pancreas and evaluation during inpatient studies. IEEE Trans Biomed Eng. 2014 Oct;61(10):2569-
2014
El Youssef J, Castle JR, Bakhtiani PA, Haidar A, Branigan DL, Breen M, Ward WK. Quantification of the glycemic response to microdoses of subcutaneous glucagon at varying insulin levels. Diabetes Care. 2014 Nov;37(11):3054-60. doi: 10.2337/dc14-0803. Epub 2014 Aug 19. PubMed PMID: 25139882; PubMed Central PMCID: PMC4207205.
2012
Ward WK, Engle JM, Branigan D, El Youssef J, Massoud RG, Castle JR. The effect of rising vs. falling glucose level on amperometric glucose sensor lag and accuracy in Type 1 diabetes. Diabet Med. 2012 Aug;29(8):1067-73. doi: 10.1111/j.1464-5491.2011.03545.x. PubMed PMID: 22150642; PubMed Central PMCID: PMC3697744.
2012
Ward WK, Castle JR, Branigan DL, Massoud RG, El Youssef J. Discomfort from an alkaline formulation delivered subcutaneously in humans: albumin at pH 7 versus pH 10. Clin Drug Investig. 2012 Jul 1;32(7):433-8. doi: 10.2165/11632840-000000000-00000. PubMed PMID: 22568666; PubMed Central PMCID: PMC3683840.
2011
Jacobs PG, El Youssef J, Castle JR, Engle JM, Branigan DL, Johnson P, Massoud R, Kamath A, Ward WK. Development of a fully automated closed loop artificial pancreas control system with dual pump delivery of insulin and glucagon. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:397-400. doi: 10.1109/IEMBS.2011.6090127. PubMed PMID: 22254332.
2011
El Youssef J, Castle JR, Branigan DL, Massoud RG, Breen ME, Jacobs PG, Bequette BW, Ward WK. A controlled study of the effectiveness of an adaptive closed-loop algorithm to minimize corticosteroid-induced stress hyperglycemia in type 1 diabetes. J Diabetes Sci Technol. 2011 Nov 1;5(6):1312-26. doi: 10.1177/193229681100500602. PubMed PMID: 22226248; PubMed Central PMCID: PMC3262697.
2011
Coombes E, Jiang J, Chu XP, Inoue K, Seeds J, Branigan D, Simon RP, Xiong ZG. Pathophysiologically relevant levels of hydrogen peroxide induce glutamate-independent neurodegeneration that involves activation of transient receptor potential melastatin 7 channels. Antioxid Redox Signal. 2011 May 15;14(10):1815-27. doi: 10.1089/ars.2010.3549. Epub 2011 Jan 26. PubMed PMID: 20812867; PubMed Central PMCID: PMC3078500.
2010
Chai S, Li M, Branigan D, Xiong ZG, Simon RP. Activation of acid-sensing ion channel 1a (ASIC1a) by surface trafficking. J Biol Chem. 2010 Apr 23;285(17):13002-11. doi: 10.1074/jbc.M109.086041. Epub 2010 Feb 25. PubMed PMID: 20185828; PubMed Central PMCID: PMC2857104.
2010
Li M, Inoue K, Branigan D, Kratzer E, Hansen JC, Chen JW, Simon RP, Xiong ZG. Acid-sensing ion channels in acidosis-induced injury of human brain neurons. J Cereb Blood Flow Metab. 2010 Jun;30(6):1247-60. doi: 10.1038/jcbfm.2010.30. Epub 2010 Mar 10. PubMed PMID: 20216553; PubMed Central PMCID: PMC2916164
2010
Inoue K, Branigan D, Xiong ZG. Zinc-induced neurotoxicity mediated by transient receptor potential melastatin 7 channels. J Biol Chem. 2010 Mar 5;285(10):7430-9. doi: 10.1074/jbc.M109.040485. Epub 2010 Jan 4. PubMed PMID: 20048154; PubMed Central PMCID: PMC2844191.
2009
Xiong JS, Branigan D, Li M. Deciphering the MSG controversy. Int J Clin Exp Med. 2009 Nov 15;2(4):329-36. PubMed PMID: 20057976; PubMed Central PMCID: PMC2802046.
2009
Jiang Q, Li MH, Papasian CJ, Branigan D, Xiong ZG, Wang JQ, Chu XP. Characterization of acid-sensing ion channels in medium spiny neurons of mouse striatum. Neuroscience. 2009 Aug 4;162(1):55-66. doi: 10.1016/j.neuroscience.2009.04.029. Epub 2009 Apr 17. PubMed PMID: 19376200.
Timeline
Clinical Research Associate
Oregon Health & Sciences University
11.2013 - Current
Research Assistant III Lead
Legacy Research Institute
11.2006 - 11.2013
Quality Control Technician
Ceva Biomune
05.2001 - 11.2006
Bachelor of Arts - Chemistry And Biology Education
University of Northern Iowa
09.1995 - 05.2000
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