Marisa Shields Email & Phone Number

New York, New York, United States

Clinical operations lead on multiple global, complex Phase I infectious disease clinical trials. Manage clinical study timeline and budget, and oversee compliance from study startup to closeout. Support the development of study protocols, and create all relevant study documents. Select and manage CROs, third-party vendors and study sites.Develop and implement all study oversight plans, lead cross-functional study teams, manage CRA’s and vendors and communicate with external stakeholders. Oversee the study Trial Master File (TMF) to ensure it is inspection-ready, and ensure internal team compliance with SOPs and protocol trainings. Oversee trial closeout, eTMF archival and CSR development.

New York, New York, United States

Clinical trail manager for multiple global, complex Phase I HIV Vaccine clinical trials.

New York, United States

Site selection lead for multiple trials, managing site feasibility, SQVs and SIVs for numerous new trial sites. Managed CRO and study vendor selection and oversight throughout the trial. Served as interim-CTM, overseeing finalization of protocol documents, site enrollment activity, monthly operations calls, study timeline and all key trial metrics.

New York, New York

Principal CRA and lead of internal CRA team, managing team trends, difficulties, and process improvements. Created numerous monitoring and study management tools, implemented across the organization. Carried-out Clinical Trial Manager tasks, including drafting key study documents, trial initiation and close-out duties. Thorough knowledge of GCP and ICH guidelines.

New York, New York

Monitor for Phase I-II infectious disease studies across multiple US sites. Accountable for onboarding, training and activating trial sites, and ensuring adherence to study protocols and GCP guidelines. Key developer of Risk Based Monitoring processes and tools, and leader of implementation for all active studies. Successfully trained two CRAs new to the field; won two organizational ‘MVP’ awards, nominated by colleagues.

1 Gustave L. Levy Place New York, Ny

Clinical research coordinator in the Cancer Institute for the Multiple Myeloma Program at Mount Sinai Hospital.Responsible for coordinating necessary appointments, and procedures according to the protocol for 8-10 phase 1, phase 2, and phase 3 multiple myleoma clinical trials. Schedule and conduct all necessary labs, biopsies, PK blood draws, doctor visits, and infusions required per protocol. First line of contact for patients on clinical trials. Screen, determine eligibility, and enroll all patients on qualifying clinical trials to meet institutional deadlines and quotas. Directly report and meet with sponsor representative and medical monitor to convey findings, protocol deviations, and any adverse events.Weekly meetings with investigator team to discuss research studies and patient enrollment, and serve as the liaison between physicians, subjects, cancer center staff, and study sponsor. Previously, data coordinator responsible for collecting and recording study data on over 25 active clinical trials related to the treatment of multiple myeloma. Analyze and interpret moderately complex clinical research data; and maintain well organized and accessible files of study documentation. Prepare for monitoring visits and audits. Additionally, obtain subject informed consent for clinical studies, and deliver and ship clinical specimens as required by the study protocol.Dec 2016: A Phase II Study of Pomalidomide, Daily Low Dose Oral Cyclophosphamide, and Dexamethasone in Relapsed/Refractory Multiple Myeloma. American Society of Hematology. Ajai Chari, MD, Hearn Jay Cho, MD, PhD, Samir Parekh, MD, Kenneth Lau, Gillian Morgan, RN, Donna Catamero, ANP-BC, Melissa Cortes, AGPCNP-BC, Meredith Curtis, AGPCNP-BC, Juliet Escalon, NP, Erika Florendo, ANP-BC, Daniel Verina, ACNP-BC, Nadege Stevens, RN, Elaine Chan, BS, Katarzyna Garcia, MS /CCRP, Lisa La, MS/CCRP, Marisa Shields, Gina Strumolo, MA and Sundar Jagannath, MD

535 East 70Th Street, New York, Ny 10021

Research Assistant in Orthopedic Surgery in the office of Dr. Mark Figgie, the Chief of the Surgical Arthritis Service at Hospital for Special Surgery. Responsibilities include: overseeing all departmental research projects from study design to publication; developing and leading new research protocols, including laboratory-based and clinical outcomes research; collaborating with orthopaedic residents, fellows and attendings on research projects; collecting data on research subjects via in-person patient recruitment, surveys, and one-on-one patient interviews; review of patient charts, imaging, etc. and maintenance of electronic research databases; preparing research protocols/applications (IRB, IACUC, HIPAA, etc) and grant proposals; identifying, consenting, and acting as a resource and person of contact for study participants; data analysis and regular presentations of findings and trends; and the writing or editing of abstracts and final manuscripts.Research projects include: Total Knee Replacement at HSS in Subjects under 35 Years of Age and JRA Dysplasia and Hemophilia Replacement of all Ages: A Multi-center Retrospective Chart Review and Patient Follow-up.Total Hip Replacement at HSS in Subjects under 35 Years of Age: Retrospective Chart Review and Patient Follow-up.Final manuscript:Outcomes After Total Hip Arthroplasty in Young Patients with Osteonecrosis of the Hip. Journal of Arthroplasty. Ishaan Swarup, M.D.; Marisa Shields, BA; Erik N Mayer, BS; Chelsea J Hendow, MS; Jayme C Burket, PhD; Mark P Figgie, MD

New York State Psychiatric Institute

Research intern at New York State Psychiatric Institute, Department of Epidemiology. Assisted Dr. Virginia Warne, Project Director, Children at High and Low Risk for Depression. Worked on 30-year cohort MDD high-risk study, under the direction of primary investigator Dr. Myrna Weissman.Performed data collection, data entry and data analysis for study on Children with High and Low Risk for Depression. Formatted figures and final manuscripts for publication. Aided in preparation of grant application for the Primary Care Act. Coordinated regularly with research team, and presented analyses with primary investigators at weekly research meetings.

600 First Ave., Ny, Ny, 10016

Worked with Dr. Girish Manohar Fatterpekar, MD, Assistant Professor; Department of Radiology (Neuroradiology). Assisted in the evaluation of treatment-related change versus tumor recurrence in high-grade gliomas using dynamic susceptibility contrast-enhanced (DSC) perfusion MRI. Authored paper entitled “Diseases of the Sella and Parasellar Region: An Overview” published in Seminars in Roentgenology, January 2013.Authored Case of the Week entitled “Spinal Dural Arteriovenous Fistula (SDAVF)” published on the American Journal of Neuroradiology website, January 2013.Presentations:• Oval Window Dysplasia: Developmental Dynamics and Imaging Correlate. Lee P, Gangadhar K, Gupta D, Hagiwara M, Raz E, Roland T, Shields M, Som PM, Fatterpekar GM. Scientific Paper. ENRS Eastern Neuroradiological Society, Montreal, October 2012• Objective Criteria to Evaluate for Progressive Supranuclear Palsy. Dietrich A, Shields M, Pantano P, Raz E, Fatterpekar GM. Scientific Paper. ENRS Eastern Neuroradiological Society, Montreal, October 2012.• A Detailed Pictorial Essay on the Superior Ophthalmic Vein: Anatomy and Pathology. Pires A, Shields M, Massimore M, Davis A, Raz E, Hagiwara M, Som PM, Fatterpekar GM. Educational Exhibit. ASHNR American Society of Head Neck Radiology, Florida, October 2012.