SHANDA D NICCO

ad31uf@r.postjobfree.com 919-***-****

Middleburg, FL 32068

SUMMARY

With over 15 years of experience, I am a seasoned clinical research professional, well-versed in pharmaceutical research across various therapeutic areas, including oncology, infectious diseases, neurology, cardiology, women's health, pediatrics, ophthalmology, and autoimmune disorders. I consistently ensure protocol compliance and strict adherence to ICH and GCP Guidelines through meticulous site monitoring. My expertise extends to the entire clinical trial lifecycle, from inception to closeout, with a focus on essential document collection, regulatory, TMF oversight, vendor management, contract negotiations, comprehension of contract terminology and general contracting, effective monitoring and communication strategies.

SKILLS

Electronic Medical Record Software

Feasibility

Direct Patient Care

IRB/EC Submissions/Review

ICH/GCP

Electronic Data Capture

CTMS

Communication Skills

Problem-Solving

Team Management

Electronic Trial Master File

Clinical Observations

Data Entry/Query Resolution

Creative Thinking

Multiple Therapeutic Areas

Budget Negotiations

Contract Management

Regulatory Management

Leadership

Protocol/ICF Review

EXPERIENCE

SENIOR CLINICAL SUPPORT SPECIALIST

Aperio Clinical Outcomes LLC Durham, NC Nov 2022-Aug 2023

Successfully managed and oversaw site start-up and activation activities, ensuring compliance with study timelines, resulting in reduction in project delays and improved efficiency.

Facilitated the review and approval of informed consent forms (ICFs) with a 100% accuracy rate, contributing to the ethical conduct of clinical trials.

Managed Central Institutional Review Board (IRB) submissions and site IRB/ethics committee renewals, achieving a 95% approval rate and maintaining regulatory compliance.

Enhanced the organization's document management by maintaining a well-organized Trial Master File (TMF), resulting in an increase in document retrievability and audit preparedness.

Collaborated with Clinical Research Associates to ensure that Trial Master Files (TMFs) were complete and up to date for all investigator sites, contributing to a 98% audit compliance rate and streamlined documentation processes.

SITE SERVICES SPECIALIST - CRC MANAGER –

WCG Threewire Eden Prairie, MN Jun 2021-Nov 2022

Effectively interviewed, trained, placed, and supervised clinical research coordinators, study coordinators, and clinical research nurses at study sites throughout United States

Deployed and managed 40 clinical research professionals for study support services, including but not limited to Media Referral Processing, Chart Review, Referral Physician Networking, Data Entry, Query Resolution, Medical Record Retrieval, Source Document Management, Targeted Study Awareness, and Subject Follow-Up

Collaborated with principal investigator and staff to facilitate daily trial activities and comply with research protocols Identified recruitment and retention gaps existing within current study processes while collaborating with clinical research sites and pharmaceutical clients to implement evidence-based study support.

CONTRACTOR, CLINICAL RESEARCH COORDINATOR

Jacksonville Center For Clinical Research Jacksonville, FL (WCG-Threewire - Contractor) Jul 2020-May 2021

Successfully recruited and enrolled patients for clinical trials through effective advertising and recruitment tools, contributing to an increase in patient participation and study efficiency.

Achieved a 98% accuracy rate in data entry and query resolution within EDC platforms (Medidata, Inform, and TrialMax) within contracted timelines, ensuring high data quality and compliance.

Managed patient retention efforts, including subject follow-up and e-diary reminders, resulting in an improvement in overall patient compliance with study protocols.

Screened patient records, databases, and physician referrals to identify prospective candidates for research studies, optimizing the screening process and saving approximately 2 hours per screening.

Educated potential patients on the study protocol and informed consent process and ensuring patient understanding and compliance with study requirements.

CONTRACTOR, IN-HOUSE CLINICAL RESEARCH ASSOCIATE I

MacroGenics Rockville, MD (Piper Companies – Contractor) Apr 2017-Dec 2019

Reviewed eCRFs both remotely, maintaining a 99% data quality rate, and contributed to a 15% reduction in data discrepancies and errors.

Successfully monitored clinical study sites for compliance with clinical monitoring plans, regulations, and GCP standards, resulting in an increase in overall study compliance.

Managed the reconciliation of source documents, regulatory documents, and drug accountability.

Monitored recruitment and data quality remotely through EDC systems/communication with sites.

Effectively managed TMF review and reconciliation

Provided guidance to study coordinators, pharmacists and laboratory technicians in proper handling, processing, and storage of study samples.

Successfully managed contract language and budget negotiations, as needed.

Efficiently managed vendor partners, ensuring smooth collaboration and achieving a 98% vendor compliance rate, leading to better operational efficiency and cost-effectiveness.

Conducted clinical trials in accordance with study protocols, recording and monitoring progress, resulting in a 100% adherence to protocol requirements and high-quality trial data.

SPECIALIST, SITE CONTRACTS

Worldwide Clinical Trials Research Triangle Park, NC Oct 2015-Jan 2017

Effectively led site contract management for US sites, resulting in a reduction in contract negotiation and execution time, expediting study initiation.

Successfully negotiated clinical trial contract language and budgets with investigators, institutions and clinical study sites in various capacities, achieving a high contract approval rate and ensuring timely study execution. (MSAs, SOWs, change orders, amendments, etc.)

Properly identify the proper agreement template to initiate clinical site negotiations.

Developed, monitored, tracked, and processed new and amended investigator contracts.

Ensured all agreements were finalized and entered into the appropriate systems.

Collaborated with the WCT Legal Department, study teams, sponsors, investigators, and clinical sites to resolve contract-related issues, resulting in a timely issue resolution rate and enhanced stakeholder relationships.

Leveraged the Grant Planning System to streamline the grants management process.

REMOTE CLINICAL MONITORING ASSOCIATE II

Parexel Durham, NC Nov 2013-Oct 2015

Successfully managed two studies covering 13 Thyroid Cancer sites and 17 Remote Monitoring sites, along with overseeing 50+ watch-list sites for Kidney Transplant Observation Research Trial, resulting in successful in study coordination and compliance.

Organized and performed remote clinical monitoring tasks and visits for designated projects, adhering to SOPs and study-specific guidelines.

Managed clinical monitoring activities remotely, including data issue resolution and patient enrollment management, contributing to a decrease in study-related issues and ensuring timely data entry.

Processed and approved payments for patient visits that had been Source Document Verified, ensuring an accurate and timely payment process, improving financial accuracy.

Retrained sites on protocols, study materials, EDC, and IVRS/IWRS, resulting in improvement in site staff adherence to study guidelines and requirements.

Successfully managed contract language and budget negotiations, as needed.

Liaised with field CRA in preparation for on-site monitoring visits and co-monitoring, as needed

CLINICAL MONITORING ASSOCIATE I

Parexel Durham, NC Dec 2011-Nov 2013

Successfully managed 22 Investigative sites remotely, along with 50+ watch-list sites for the Kidney Transplant Observation Research Trial and 15 sites for the Cardiovascular Study, ensuring a 20% increase in study coordination efficiency.

Collaborated with CRAs to address site issues and actions, leading to a reduction in unresolved issues and improved study site performance.

Performed regular EDC data reviews, ensuring a 98% data quality rate, and significantly reducing data discrepancies and errors.

Developed study tools to enhance productivity and consistency, leading to an increase in adherence to the Study Reference Manual and other study-related plans.

Successfully negotiated agreement language with clinical study sites to reach a shared understanding of deliverables, a timely study start-up and financial obligations, as needed. (MSAs, SOWs, change orders, amendments, etc.)

Developed, monitored, tracked, and processed new and amended investigator contracts.

Ensured all agreements were finalized and entered into the appropriate systems.

Conducted audits as requested by Parexel to prepare for FDA audits, ensuring a 100% compliance rate and enhancing overall audit readiness.

CLINICAL TRIAL SPECIALIST II-CONTRACT FOCUS

Parexel Durham, NC Dec 2009-Sep 2011

Successfully managed global contract language and budget negotiations across 8 studies in CAN, LATAM, and APAC, resulting in a reduction in contract negotiation time and enhancing international study coordination. (MSAS, SOWs, change orders, amendments, etc.)

Properly identify the proper agreement template to initiate clinical site negotiations.

Developed, monitored, tracked, and processed new and amended investigator contracts.

Ensured all agreements were finalized and entered into the appropriate systems.

Managed up to 180+ site contracts concurrently, achieving an improvement in contract processing efficiency by implementing streamlined workflows.

Reviewed and negotiated site contracts and budgets, achieving a 98% contract approval rate and ensuring adherence to applicable ICH Guidelines and regulations.

Trained onboarding staff on the Contract and Budget process, resulting in a 25% reduction in onboarding time and improved accuracy in contract management.

Conducted feasibility and site pre-qualification activities, enhancing site selection processes, and contributing to a reduction in site activation timelines.

CLINICAL TRIAL SPECIALIST I

Parexel Durham, NC Jul 2008-Dec 2009

Conducted feasibility and site pre-qualification activities, leading to a reduction in site selection timelines and an improvement in study site quality.

Managed study start-up activities and regulatory documentation review and completion (Statement of Investigator, CVs, Licensing credentials, IRB/EC submissions, ICF completion, etc.)

Prepared and submitted site documentation to Central IRB/EC for study approval.

Reviewed and maintained Trial Master Files (TMFs) to ensure inspection readiness, resulting in a 10% increase in TMF audit compliance.

Negotiated Clinical Study Agreements (CAN, LATAM, APAC) and budgets based on Fair Market Value, achieving a 95% contract approval rate. (MSAs, SOWs, change orders, amendments, etc.)

Successfully prepared and submitted MoH/Regulatory Authority documentation, contributing to an on-time final study approval rate of 90%.

Provided operational support for the delivery of assigned studies within budget and on time, leading to a 10% improvement in study cost-effectiveness and meeting project-related timelines.

Ensured accurate project tracking and Clinical Trial Management System (CTMS) maintenance, resulting in 100% accuracy in project timelines and contractual obligations.

CLINICAL TRIAL ASSOCIATE

Parexel Durham, NC Mar 2008-Jul 2008

Prepared and emailed study regulatory packets, including various documents, leading to reduction in document delivery time and streamlining the document distribution process.

Reviewed and maintained Trial Master Files (TMFs) to ensure inspection readiness, resulting in a 98% audit compliance rate and efficient document management.

Ensured project tracking and Clinical Trial Management System (CTMS) were up to date and accurate, consistently meeting project-related timelines and contractual obligations with 100% compliance.

Performed general administrative duties, such as central files coding, submission, photocopying, scanning, and processing mass mailings, enhancing project team efficiency.

Maintained a working knowledge of applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and assured compliance with PAREXEL WSOPs, ensuring regulatory adherence and contributing to study quality.

PROJECT ASSISTANT

PPD Morrisville, NC Oct 2006-Jan 2008

Provided day-to-day administrative support to the Project Study Team, resulting in a 30% improvement in team productivity and coordination.

Reviewed and maintained Trial Master Files, ensuring inspection readiness, and achieving an audit compliance rate.

Accountable for triggering the shipment of clinical study supplies, leading to a reduction in shipment processing time and improved supply chain efficiency.

Successfully reviewed and transmitted regulatory documents in accordance with FDA, GCP, WPD, and SOPs, achieving on-time document submission rate and ensuring compliance.

Effectively communicated potential issues with clients, vendors, and project teams, mitigating future occurrences that might negatively impact studies, resulting in a decrease in study-related issues.

EDUCATION AND TRAINING

High School Diploma

Person Senior High School, Roxboro, NC June 1990

SYSTEMS

Veeva; Florence; IMPACT; SimpleTrials; Medidata Rave, Inform, TrialMax: Endpoint;

Clinasyst, MasterControl, Advarra

CERTIFICATIONS

Six Sigma/Lean Sigma – White Belt

STUDY IDICATIONS

Ulcerative Colitis Study (Phase 2b); Crohn's Disease (Phases 1 & 3)

Cardiovascular – Obesity (Phase 3b); Cardiovascular (Phase 1 & Phase 3)

COVID-19 Study (Phase 3)

Oncology (Phases 1- 3) - Melanoma, Squamous Cell Cancer of the head and neck,

Non-small Cell Lung Cancer Mesothelioma, Urothelial Cancer, Clear Cell Renal

Cell Carcinoma, Ovarian Cancer, Thyroid Cancer, Triple-negative Breast Cancer,

Pancreatic Cancer, Colorectal Cancer, Soft Tissue Sarcoma, Prostate Cancer

(Phase 1), Pancreatic Cancer, Lung Cancer, Oncology/Hematology Disorders

(Phase 1-3), Intractable Pain Associated with Cancer Epidural Resiniferatoxin

(Phase 1b)

Nephrology - Kidney Transplant

Dermatology - Psoriasis (Phase 2), Chronic Plaque Psoriasis (Phase 3)

Endocrinology - Diabetes (Phase 1)

Musculoskeletal

Pediatrics/Neonatology

Pulmonary - Arterial Hypertension (Phase 3), Idiopathic Pulmonary Fibrosis

Rheumatology (Phase 2)

Observational/Registry (Phase 1)

Reproduction (Obstetrics & Gynecology)

Orthopedics/Orthopedic Surgery (Phase 2)

Neurology and CNS (Phase 1-3); Alzheimer's & Mild Alzheimer's Disease (Phases 1

& 3); Frontotemporal Dementia (Phase 2)

Autoimmune (Adolescents Sickle Cell Disease (Phase 2), Systemic Lupus

Erythematosus (Phase 2b)

Attention Deficit/Hyperactivity Disorder (Phase 1)

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