Melissa Cohen
Minneapolis,MN
Summary
Dynamic clinical research coordinator with a proven track record of managing clinical trials and ensuring strict adherence to protocols while maintaining meticulous documentation. Expertise in patient recruitment, data collection, and regulatory submissions, complemented by a results-driven approach that consistently leads to successful study outcomes. Strong focus on fostering team collaboration and adaptability to meet evolving project demands, contributing to a cohesive and efficient research environment. Committed to making a significant impact in the field of clinical research through dedication and professionalism.
Overview
43
43
years of professional experience
Work History
Clinical Research Coordinator
Veterans Administration Medical Center, Division of Cardiology
05.2022 - Current
- Responsible for the daily management of the study operations including recruitment, enrollment and follow up of study participants in the division of Cardiology.
- Facilitated adherence to GCP and IRB guidelines through comprehensive management of protocol-related activities.
- Designed comprehensive policies and procedures aimed at enhancing best practices within research initiatives.
- Led collaboration efforts with health care providers and study personnel to enhance project execution. Managed relationships with regulatory agencies and sponsor representatives to ensure compliance and alignment. Fostered teamwork to drive successful project outcomes.
- Managed the preparation and submission of regulatory documents in alignment with local and central IRB guidelines.
- Developed comprehensive budgets and contracts to ensure project alignment with organizational goals.
- Directed monitoring and reporting of research data to ensure accuracy and compliance.
- Facilitated training sessions for health care personnel and stakeholders on research-related activities.
Clinical Research Coordinator
Mayo Clinic Division of Hematology/Oncology CAR-T
Rochester, MN
01.2021 - 05.2022
- Executed coordination of high-risk interventional therapeutic clinical research protocols, maintaining strict compliance with regulatory requirements and institutional guidelines.
- Engaged with research team to analyze feasibility and implement strategies for effective recruitment of research participants.
- Managed scheduling logistics and monitored research activities to ensure effective subject participation.
- Conducted thorough reviews and generated reports on adverse events and protocol deviations to ensure compliance and safety.
- Directed monitoring and reporting of research data to uphold quality assurance and regulatory compliance.
- Facilitated educational sessions and training programs for departmental staff.
- Executed administrative and regulatory responsibilities to ensure compliance with study protocols.
Clinical Research Coordinator II
SUNY Upstate Medical Center (ICON Clinical)
Syracuse, NY
08.2020 - 12.2020
- Managed coordination of multiple research trials for Institute for Global Health, encompassing early to late phase FDA-regulated studies.
- Oversaw design, administration, and monitoring of clinical trials to ensure compliance and integrity.
- Engaged with clinicians, sponsors, and cooperative groups to ensure compliance with institutional review board and regulatory standards.
- Oversaw patient enrollment, registration, and screening processes for clinical research trials. Managed collection and submission of clinical trial patient data to ensure compliance and accuracy.
- Managed administrative tasks encompassing proper collection and shipment of lab samples, billing assistance, and oversight of clinical research study supplies and drug inventory.
- Supported growth and skill enhancement of junior CRCs to ensure operational efficiency.
- Facilitated ongoing communication with principal investigator regarding research study progress and compliance.
- Performs light duties and other related duties as required and assigned.
Clinical Research Coordinator
University of Minnesota, Division of Anesthesiology
Minneapolis, MN
03.2015 - 08.2020
- Achieved successful management of multiple clinical research studies through effective oversight of sponsored and investigator-initiated projects. Streamlined coordination of study activities, including regulatory submissions, budget management, protocol training, and subject recruitment. Secured timely approvals by managing documentation submissions to regulatory boards and ethics committees.
- Achieved enhanced quality care in perioperative settings through the development of investigator-initiated trials. Delivered ERAS protocols for several surgical subspecialties, facilitating improved patient outcomes. Launched a new initiative at University of Minnesota and Fairview Southdale for effective fluid resuscitation in septic shock. Developed protocols, order sets, and trained hospital personnel in data collection and interpretation to optimize clinical pathways.
- Led initiatives to implement project management systems and practices across teams. Guided research and analysis processes to interpret information from various sources, enhancing decision-making.
- Oversaw data collection and documentation processes, including adverse event reporting, to maintain accurate records. Championed good clinical practices in clinic investigations by leveraging expertise in FDA regulations and human subject protection. Drove compliance with protocols and regulatory standards to enhance research integrity.
- Facilitated participant recruitment and screening processes to obtain written informed consent in compliance with established protocols.
- Facilitated multidisciplinary team meetings to advance the development of investigator-initiated protocols. Oversaw the preparation of protocols for IRB submission to ensure compliance and thoroughness.
- Engaged with research partners on national and international levels to foster collaboration.
- Compiled relevant data and prepared comprehensive research protocols alongside grant proposals and letters of intent for funding acquisition.
- Executed comprehensive literature searches and retrieved relevant journal articles.
- Facilitated writing and summarizing of data and statistical analyses for research reports and presentations.
- Facilitated submission of documentation to regulatory boards and ethics committees for approval.
- Managed data entry from studies and projects, ensuring consistency and cleanliness.
- Assist in designing data collection forms and developing databases (Microsoft Access, REDCap)
- Ensured adherence to institutional policies governing research involving human subjects.
- Collaborated on assigned quality improvement projects to optimize departmental performance.
- Supported research initiatives and quality improvement audits by completing assigned tasks as outlined by leadership.
Clinical Research Coordinator
University of Minnesota, Transplant, hepatology and Infectious Disease
Minneapolis, MN
02.2005 - 03.2015
- Achieved successful execution of clinical trials in kidney and liver transplant hepatology and infectious diseases, managing all aspects from initiation to closeout. Enhanced subject enrollment and screening processes; optimized randomization and registration of eligible subjects to assigned studies. Improved scheduling and conducting of study visits for both inpatient and outpatient participants; executed all protocol-related activities, including specimen collection and patient assessments. Monitored subjects' clinical status and effectively communicated pertinent medical conditions to the principal investigator and medical personnel. Streamlined data collection and reporting for source documentation and case report forms. Coordinated efforts among related departments involved in the study process. Prepared and submitted regulatory information to appropriate agencies while contributing to budget development. Maintained comprehensive knowledge of GCP, IRB, and HIPAA guidelines. Reported all significant adverse events promptly. Conducted regular monitoring visits and efficiently managed study closeout procedures.
- Supported budget proposal preparation and facilitated routing forms for contract submissions to sponsored projects.
- Oversaw development and maintenance of relational database for liver transplantation initiatives. Coordinated data gathering for UNOS submissions to enhance reporting accuracy. Led efforts in querying database for scientific presentations. Contributed to the strategic development of OTTR for comprehensive solid organ transplant data management.
Clinical Research Coordinator
University of Minnesota, Transplant and Immunology
Minneapolis, MN
11.2003 - 02.2005
- Achieved successful coordination of clinical trials for islet cell transplantation in severe type I diabetes patients, enhancing patient enrollment and participation. Delivered effective management of patient admissions, study protocol execution, and monitoring throughout hospital stays. Improved follow-up visit scheduling and evaluations for patients in university and outpatient settings. Enhanced post-transplant care through diligent monitoring of laboratory values and adverse events. Established a robust database for tracking patient data and conducting statistical analyses. Streamlined regulatory documentation and submissions to university departments and NIH. Optimized budget preparation processes for various study protocols.
Clinical Research Coordinator
Hennepin County Medical Center
05.1999 - 11.2003
- Achieved successful execution of clinical trials in critical care heart failure and cardiac interventions, enhancing departmental research capabilities. Delivered comprehensive regulatory documentation, including consent forms and IRB applications, facilitating smooth trial initiation. Streamlined patient recruitment and screening processes, ensuring protocol adherence. Monitored patient safety and data integrity throughout studies, completing necessary documentation for adverse events. Enhanced staff knowledge of study protocols, improving overall trial execution.
Research Coordinator
University of Minnesota, Department of Orthopaedic Surgery
Minneapolis, Minnesota
02.1983 - 05.1999
- Oversaw coordination of retrospective and prospective research projects, implementing study algorithms and database design.
- Managed comprehensive study design implementation and conducted statistical analyses to support research objectives.
- Facilitated abstract and manuscript preparation, ensuring clarity and adherence to publication standards.
- Developed and managed a comprehensive database for orthopedic diseases and deformities.
- Formulated and established study protocol algorithms to enhance the efficiency of clinical trials involving drug and device evaluations.
- Oversaw grant development initiatives to align with organizational goals. Managed relationships with funding agencies to foster collaboration and support. Coordinated project teams to ensure timely submission of grant proposals.
- Developed and delivered scientific presentations, publications, and exhibits.
Education
BA - Political Science and Economics
University of Wisconsin
MadisonBS - Microbiology/Immunology
University of Minnesota
Minneapolis, MNMA Education - undefined
University of Wisconsin
RiverfallsSkills
- Extensive experience with EPIC, Redcap, Access, Microsoft Word, Excel, Powerpoint, SPSS, Adobe products Numerous commercial database repositories Project management software Oncore, Rogue
Timeline
Clinical Research Coordinator
Veterans Administration Medical Center, Division of Cardiology
05.2022 - Current
Clinical Research Coordinator
Mayo Clinic Division of Hematology/Oncology CAR-T
01.2021 - 05.2022
Clinical Research Coordinator II
SUNY Upstate Medical Center (ICON Clinical)
08.2020 - 12.2020
Clinical Research Coordinator
University of Minnesota, Division of Anesthesiology
03.2015 - 08.2020
Clinical Research Coordinator
University of Minnesota, Transplant, hepatology and Infectious Disease
02.2005 - 03.2015
Clinical Research Coordinator
University of Minnesota, Transplant and Immunology
11.2003 - 02.2005
Clinical Research Coordinator
Hennepin County Medical Center
05.1999 - 11.2003
Research Coordinator
University of Minnesota, Department of Orthopaedic Surgery
02.1983 - 05.1999
BS - Microbiology/Immunology
University of Minnesota
MA Education - undefined
University of Wisconsin
BA - Political Science and Economics
University of Wisconsin
PRESENTATIONS
- Fred Behrens, M.D., Melissa Cohen: A Prospective Study of 100 Open Tibial Fractures, Canadian Orthopedic Society Meeting, Montreal Canada, 1984.
- Oheneba Boachie-Adjei, M.D., James West, M.D., Melissa Cohen: Decompensation Following CotrelDubousset Instrumentation: A Worrisome Complication. Presented at the Spine Research Society Meeting, Baltimore, Maryland, 1988.
- Transfeldt E, Bradford D, Heithoff K, Cohen M: Changes in Segmental Coupling and Vertebral Rotation Following Cotrel-Dubousset Instrumentation for Idiopathic Scoliosis. Presented at the Spine Research Meeting, Baltimore, Maryland, 1988.
- Henry Barnard, M.D., Melissa Cohen, James Ogilvie, M.D: Complications of CD Fixation. Presented at the Spine Research Society Meeting, Honolulu, Hawaii, 1990. (Also presented at the American Academy of Orthopedic Surgeons, Anaheim, CA, 1991.
- Mark Heller, M.D., Ensor Transfeldt, M.D., Melissa Cohen: Blood Loss and Transfusion in Spinal Surgery. Presented at the North American Spine Society Meeting, Chicago IL, June 1996.
- Banks G, Cohen M, Hu S, Garvey T, Transfeldt E: Ted Hose vs. Sequential Compression Boots for the Prevention of Deep Venous Thrombosis Following Elective Thoracolumbar Spine Surgery. American Academy of Orthopedic Surgeons, San Francisco, CA, 1993.
- Garry V., Morrison J, Harkins, M, Cohen M: Regional differences in cardiovascular mortality in Minnesota: 1987-1997. Minnesota Medicine, April 2000.
- Cohen M, Bradford DS, Ogilvie JW, Boachie O: A Clinical Research Database for the Study of Spine Diseases and Deformity. Presented at the Spine Research Society Meeting, Amsterdam, Holland, 1989 and Honolulu, Hawaii, 1990.
- Cohen M, Transfeldt E, Heller M: The Need for Transfusions and Cell Saver Use in Surgery for Degenerative Spine Disease. Presented at the International Society for the Lumbar Spine, Chicago, IL, May 20-24, 1992.
- Banks G, Cohen M, Hu S, Garvey T, Transfeldt E: Ted Hose vs. Sequential Compression Boot for the Prevention of Deep Venous Thrombosis Following Elective Thoracolumbar Spine Surgery. Scoliosis Research Society, Kansas City, MO, September, 1992.
- Cohen M, Nagata H, Transfeldt E: Natural History of Spinal Balance and Decompensation in Adolescent Idiopathic Scoliosis. Scoliosis Research Society, Kansas City, MO, September, 1992.
- Boachie-Adjei O, West J, Cohen M: Decompensation Following Cotrel-Dubousset Instrumentation: A Worrisome Complication. Spine, 1990.
- Bradford DS, Heithoff K, Cohen M: Spinal Abnormalities and Congenital Spine Deformities. Pediatric Spine, 1990.
- Transfeldt E, White, D, Bradford D, Ogilvie J, Kahmann R, Cohen M: Delayed Anterior Decompensation in Patients with Spinal Cord and Cauda Equina Injuries of the Thoracolumbar Spine. Orthopaedic Transactions, Vol. 14(3), 1990.
- Cohen M, Bradford D, Ogilvie J, Boachie-Adjei O, Transfeldt E: Clinical Research Database for the Study of Spinal Disease and Deformity and Disease. Orthopedic Transactions. Vol. 14(3), 1990.
- Geissle R, Ogilvie J, Cohen M: Thoracoplasty for the Treatment of Rib Prominence in Thoracic Scoliosis, Spine 19(4):36-42, 1994.
- Engebretsen L, Grontvedt, T, Cohen M: Current Concepts in Knee Arthroscopy, Scandanavian Journal of Sports Medicine, February, 1995.
- Hu S, Bradford D, Transfeldt E, Cohen M: Reduction of High Grade Spondylolisthesis Using Edwards Instrumentation. Spine 21:367-371, 1996.
- Butterman, G, Heithoff K, Ogilvie, J, Transfeldt E, Cohen M: Vertebral Body MRI Related to Lumbar Fusion Results, Spine (Eur) 6:115-120, 1997.
- Morken JJ, West MA, Rodriguez JL, Cohen M: Temporary Abdominal Closure (TAC): Bogota Bag is Superior to Skin Closure. American Surgeon, March 2002.
- Wright BE, Rodriguez JL, Cohen M: Laparoscopic Umbilical Hernia Repair: A Reasonable Alternative to Conventional Repair. American Surgeon, March 2002
- Danielson D, Zera RT, Rodriguez JL, Cohen M, et al: Atypical Hyperplasia (AH), Proliferative Fibrocystic Change (PFC), and Exogenous Hormone Use (EHU). Central Surgical Association, Tucson AZ, June 2001.
- Heagy W, West MA, Hansen C, Nieman, Cohen M, et al: Impaired Ex Vivo LPS-Stimulated Whole Blood TNF Production May Identify Septic ICU Patients. Surgical Infection Society, 2001. (Publication in Progress)
- Heagy W, Hansen C, West MA, Rodriguez JL, Nieman K, Cohen M: LPS- Stimulated Whole Blood IL-6 Secretion is Not Associated with Poor Clinical Outcome. Association for Academic Surgery, November 2000.
- Transfeldt E, Heller M, Cohen M: Blood Loss and Transfusion in Patients Undergoing Spinal Surgery, Blood Loss in Spinal Surgery: Prevention and Replacement, Spine; State of the Art Reviews Volume 5:No. 1, Hanley and Belfus Inc, Philadelphia, PA, 1991.
- Gilbert T, Cohen M: Imaging of Acute Injuries to the Wrist and Hand. Radiologic Clinics of North America, (Ed.) G. El-Khoury, Volume 35 (3):701-26, 1977.
- Putnam M, Cohen M: Malignant Bony Tumors of the Upper Extremity: Hand Clinics: Tumors of the Hand and Forearm, 1995.
- Putnam MD, Cohen M: “Forearm Fractures”. Peimer CA (ed) in Surgery of The Hand and Upper Extremity, McGraw-Hill, New York. To be published Fall 1995.
CLINICAL TRIALS
- A Phase II Study to Determine the Efficacy and Safety of LY315920 in Patients with Severe Sepsis. Sponsor, Lilly - June 1999-December 2000.
- A Multicenter Phase III Study to Assess the Safety and Efficacy of Bactericidal/ PermeabilityIncreasing Protein (rBPI21) in Patients with Hemorrhage Due to Trauma. Sponsor, Xoma - June 1999-December 2000.
- Chiron/Searle Study TFP007 Multicenter, Double Blind, Placebo Controlled, Randomized, Phase 3 Study of Tifacogin [Recombinant Tissue Factor Pathway Inhibitor (rTFPI/SC-59735)] in Severe Sepsis. Sponsor, Chiron Corporation - August 1999-December 2001.
- Protocol LOFBIV-PNOP-001: A Multicenter, Randomized, Open Label Study To Compare The Safety And Efficacy Of Levofloxacin With That Of Imipenem/Cilastatin In The Treatment Of Nosocomial Pneumonia. Sponsor, Ortho McNeil - July 2000-March 2001.
- A Prospective, Multicenter Study of the Anemia of Critical Illness and Transfusion in the Critically Ill Patient. Sponsor, Ortho Biotech - December 2000- May 2000
- APX-PHP 99-004: A Phase 3 Multi-Center, Randomized, Placebo Controlled Study of PHP when Administered by Continuous Infusion in Patients with Shock Associated with Systemic Inflammatory Response Syndrome (SIRS). Sponsor, Apex Corporation - July 2000 - ongoing.
- A Randomized, Double-Blind, Multi-Center, Comparative Study of Intravenous BMS284756 followed by Oral BMS 284756 versus Intravenous Piperacillin/tazobactam followed by Oral Amoxicillin/Clavulanate In The Treatment of Complicated Intraabdominal Infections. Sponsor - Bristol Meyers Squibb - September 2000 - June 2002
- Prospective, Randomized, Double Blind Comparison of the Efficacy and Safety of Sequential Treatment with IV/PO Moxifloxacin (Bay 12-8039) Versus Ceftriaxone IV/PO Cefuroximeaxetil in Patients with Nosocomial Pneumonia. Sponsor, Bayer - July 2001-February 2002.
- Protocol SPI-001: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, ParallelGroup, Dose-Ranging Evaluation of the Safety and Efficacy of -hANP Infusion (Carperitide for Injection: SUN 4936) in Patients with Acute Respiratory Distress Syndrome (ARDS). Sponsor, Suntory - April 2000 - ongoing
- Protocol No: 766-INF-0026-128. Linezolid vs. Vancomycin for the Treatment of Complicated Skin and Soft Tissue Infections Suspected of Being or Proven to be Due to a Methicillin Resistant Gram-Positive Bacterial Pathogen. Sponsor, Pharmacia-Upjohn - February 2002 - ongoing.
- A Multicenter, Randomized, Double Blind, Comparative Trial of Intravenous MERREM (meropenem, ICI 194,660) vs. PRIMAXIN I.V. (imipenemcilastatin) in the Treatment of Hospitalized Subjects with Complicated Skin and Skin Structure Infections (Trial # 3591IL/0079). Sponsor, Astra Zeneca - February 2002-ongoing.
- Protocol No: E5564-A001-201. A Double-Blind, Placebo-Controlled, Study of E5564, A Lipid A Antagonist, Administered by Twice Daily Intravenous Infusions in Patients with Severe Sepsis. Sponsor, Eisai Corporation - February 2002-ongoing.
- Protocol Number: 124C1313. A Multicenter Phase III, Double-Blind, PlaceboControlled, Parallel, Parallel Study of ADL 8-2698 in Opioid-Induced Postoperative Bowel Dysfunction/Postoperative Illeus. Sponsor, Adolor Corporation - June 2002-ongoing.
- Protocol Number: 100272. A Prospective, Randomized, Double Blind Multi-Center Trial Assessing the Safety and Efficacy of Sequential (intravenous/oral) BAY 128039 (moxifloxacin) 400mg every 24 hours Compared to Intravenous Piperacillin/Tazobactam 3.375 grams every 6 hours followed by oral amoxicillin/clavulanic acid suspension 800 mg every 12 hours for the treatment of patients with complicated intraabdominal infections. Sponsor, Bayer Corporation - May 2002-ongoing.
- Protocol Number: 3001069 REVIVE Study. Randomized, Multicenter Evaluation of Intravenous Levosimendan Efficacy vs. Placebo in the Short Term Treatment of Decompensated Heart Failure.
- Sponsor ORION, December 2002-ongoing.
- Protocol Number 087-CL-071. A Randomized, Double-blind, Placebo-controlled, Dose-ranging Pilot Study Evaluating the Efficacy and Safety of YM087 in Patients with Decompensated Chronic Heart Failure. Sponsor, Yamanouchi-December 2002-present.
- CHARM Study: Candesartan Cilexetil in Heart Failure Assessment of Reduction Mortality and Morbidity. Sponsor, Astra Zeneca. 2001-June 2003.
- CHF Solutions: A randomized Controlled Trial of Ultrafiltration for Decompensated Heart Failure. Sponsor-CHF Solutions, April 2003-ongoing.
- EVOLVE: A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Examine the Safety and Efficacy of Intravenous MCC-135 as an Adjuct to Standard Therapy with Primary PCI in Patients Diagnosed as Having an ST Elevation Acute Myocardial Infarction.
- Sponsor-Mitsubishi, May 2003-present.
- Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial – EXTended Criteria Donors (BENEFIT-EXT), Sponsor-Bristol Myers Squibb, March 2005present
- Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial (BENEFIT). Sponsor, Bristol Myers Squibb, August 2006-present.
- A phase 2, multi-centre, randomized, double-blind, placebo-controlled, parallel-group (3 arms) pilot study to assess the efficacy, the safety and the pharmacokinetics of two treatment schedules of reparixin in the prevention of delayed graft function after kidney transplantation in high risk patients. Sponsor, Dompe (Italy), March 2005-present.
- A Sequential Adaptive Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE). Sponsor, Bristol Myers Squibb, September 2007.
- A Randomized, Double-Blind, Placebo Controlled Multi-Center Study of the Efficacy and Safety of up to 100 days vs. up to 200 Days of Valganciclovir for Prevention of Cytomegalovirus Disease in High-Risk Kidney Allograft Recipients. Sponsor, F. Hoffman Roche, November 2006-present.
- A 4-week, multicenter, double-blind, randomized, parallel group study to compare the gastrointestinal safety and tolerability of myfortic and MMF (Cellcept) when administered in combination with calcineurin inhibitors in renal transplant recipients experiencing gastrointestinal intolerance. Sponsor, Novartis, November 2006-present.
- A Sequential Adaptive Phase II/III Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE). Sponsor, Bristol Myers Squibb, December 2007-present.
- Evaluation of Belatacept as First-line Immunosuppression in De Novo Liver Transplant, Bristol Myers Squibb, January 2009-present
- Rheos Pivotal Trial , Baroreflex Therapy for Malignant Hypertension, Sponsor CVRX, October 2009present
- A 12 month, multi-center, randomized, open-label non-inferiority study comparing the safety and efficacy of concentration-controlled Everolimus with low dose tacrolimus to CellCept (mycophenolate mofetil) with standard dose tacrolimus in de novo renal transplant recipients, Novartis Pharmaceuticals, September 2010-ongoing.
- A pilot randomized, double-blind, placebo-controlled trial of caspofungin empirical therapy for invasive candidiasis in high-risk adults in the critical care setting, Sponsor Merck, September 2011-present.
- AEB071B: A 24-month randomized multicenter study evaluating safety and efficacy of sotrastaurin (STN) combined with tacrolimus (TAC) vs a tacrolimus/mycophenolate mofetil (MMF) based control regimen in de novo liver transplant recipients, Novartis Pharmaceuticals, March 2011-ongoing.
- A Phase 2, Randomized, Multicenter, Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Efficacy, Safety, and Population Pharmacokinetics of Once-Daily Oral E5501 Tablets Used Up to 7 Days in Subjects with Chronic Liver Diseases and Thrombocytopenia Prior to Elective Surgical or Diagnostic Procedures, Eisai Pharmaceuticals. September 2010completed. December, 2011.
- A Multi-Center, Randomized, Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 with Lucassin (Terlipressin) (REVERSE Trial), Ikaria, May2011-present.
- Pharmacokinetics, Safety, and Tolerability of Intravenous Posaconazole Solution Followed by Oral Posaconazole Suspension (SCH 56592) in Subjects at High Risk for Invasive Fungal Infections, Merck, May 2012 to February 2013.
- A Randomized, Open-Label, Multicenter, Controlled Study To Assess Safety and Efficacy of ELAD In Subjects With Alcohol Induced Liver Decompensation (AILD), Vital Therapies, February 2013-ongoing.
- A Multicenter, Open-Label Trial to Evaluate the Safety And Efficacy of the Sufentanil Sublingual Tablet 30 Mcg in Patients with Post-Operative Pain, AcelRx, September 2016-September 2017
- A Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Safety and Efficacy of EXPAREL When Administered via Infiltration into the Transversus Abdominis Plan (TAP) Versus Bupivacaine Alone in Subjects Undergoing Elective Cesarean Section, Pacira Pharmaceuticals, Dec-2017 Ongoing
- Transversus Abdominis Plane (TAP) Infiltration vs. Surgical Infiltration of Local Anesthetic in Laparoscopic and Robotic assisted Hysterectomy March 2016-March 2017
- Corticosteroid Lumbar Epidural Analgesia for Radiculopathy (C.L.E.A.R.), Semnur Pharmaceuticals, December 2017-present