Clinical Research Trial

Angerine D. McCook-Fields

Clinical Research Professional

Sicklerville, NJ 08081 908-***-****

**********@*****.*** linkedin.com/in/angerine-mccook-fields-ba-mha-5971117

Professional Summary

Experienced clinical research professional with a strong track record in managing Phase I–III trials, regulatory compliance, and site monitoring. Skilled in GCP adherence, budget management, and risk mitigation, with expertise in building cross-functional relationships and optimizing clinical trial operations. Proven ability to lead teams, drive process improvements, and ensure high-quality, timely deliverables.

Skills

Therapeutic Areas:

Cardiovascular

Respiratory

CNS

Dermatology

Diabetes

Endocrinology

Inflammation

Metabolic Diseases

Pulmonology

Thrombosis

Vaccines

Technical Skills:

Investigational product

Data integrity

Site initiation

Site management

Resource management

Clinical database systems

EDC - InForm system

Medidata Rave

Oracle. Siebel CRM

Veeva System

Data management

Clinical trial reporting

Greenphire (investigator/site payment system)

Work Experience

ICON CLINICAL RESEARCH, INC., Raleigh, NC 02/2021 – 03/2025

Clinical research organization (CRO).

Senior Clinical Trial Manager

Responsible for the delivery of all clinical aspects of clinical studies. Oversaw and served as the liaison between the project manager and a group of clinical research associates (CRAs) assigned to a given clinical study, for the delivery of all aspects of monitoring and site management.

Reviewed and approved investigation payments at multiple sites.

Oversaw five field CRAs (through weekly team huddle, tasks, and onboarding).

Evaluated and finalized monitoring visit reports.

Communicated trial status within and outside the study team to ensure cross-functional alignment of expectations, priorities, and deliverables (subject enrollment, clinical monitoring activities, clinical site compliance, and data metrics).

Ensured consistency with ICH and GCP and applicable ICON standard operating procedures (SOPs), applicable regulations, and the monitoring plan, and ensured the clinical portion of the study was always inspection-ready.

Coordinated the development and distribution of critical study documents, including ICFs, operational study documents, reference documents, study newsletters, site materials, and other study-related documents.

Supported the development of clinical study protocols, clinical study reports, and other documents as needed.

Ensured documents were filed appropriately in the TMF.

CYTOSORBENTS, MEDICAL INC., Monmouth Junction, NJ 06/2019 – 05/2020

Medical device company.

Clinical Study Manager

Responsible for overseeing various aspects of clinical trials, including study execution, site management, and ensuring compliance with regulatory standards.

Collaborated with data management to identify data discrepancies, mitigate risks, and implement corrective action plans to safeguard trial integrity.

Oversaw clinical study plans and risk mitigation strategies, escalating complex challenges and ensuring alignment across cross-functional stakeholders.

Spearheaded end-to-end management of a pivotal clinical trial, ensuring timely site activation and study execution in alignment with regulatory standards, timelines, and budgets.

Directed cross-functional teams and clinical vendors, ensuring adherence to study protocols, quality metrics, and key deliverables while maintaining compliance with ICH-GCP and FDA regulations.

Played a critical role in protocol development, case report forms (CRFs), informed consent forms (ICFs), and other essential study documents in collaboration with clinical affairs and clinical operations leadership.

ALLERGEN, INC., (Syneos Health), Madison, NJ 05/2018 – 11/2018

Pharmaceutical company.

Clinical Trial Manager

Responsible for overseeing all aspects of clinical trial operations, including protocol compliance, site monitoring, data integrity, vendor management, and inspection readiness.

Accountable for project financials, including forecasting, budget tracking, and performance optimization for assigned studies.

Proactively identified operational risks and implemented contingency plans to support the timely, compliant delivery of study goals.

Led cross-functional clinical research programs for cardiovascular Phase II and IV trials, ensuring quality execution, budget adherence, and timely delivery of project milestones.

Oversaw all aspects of clinical trial operations, including protocol compliance, site monitoring, data integrity, vendor management, and inspection readiness.

Served as primary point of contact for the sponsor (Allergen), maintaining high client satisfaction and ensuring transparent communication of deliverables, progress, and risk mitigation strategies.

NOVARTIS PHARMACEUTICAL, East Hanover, NJ 04/2017 – 01/2018

Pharmaceutical company.

Senior Global Trial Manager

Responsible for ensuring the timely, efficient, and high-quality execution of clinical trials, while also managing resources, budgets, and focusing on the operational aspects of clinical trials within a specific program or therapeutic area.

Deputized for GTD in CTT (clinical trial team) meetings, providing operational leadership and ensuring continuity of decision-making and execution.

Contributed to the implementation of best practices across global clinical operations, serving as a subject matter expert (SME) and mentor to new hires during onboarding and training.

Supported development and deployment of study tools, SOPs, training materials, and presentations for cross-functional team onboarding and trial execution.

Monitored in-house trial activity, coordinated site initiation activities, and contributed to protocol compliance through proactive site engagement and query resolution.

Collaborated with the global program operations manager (GPOM) and global trial budget manager (GTBM) to develop, forecast, and track trial budgets, maintaining alignment with financial goals.

DAIICHI SANKYO, INC., Edison, NJ 06/2016 – 03/2017

Pharmaceutical company.

Clinical Study Manager

Responsible for the operational execution of clinical trials, ensuring they were conducted according to good clinical practice (GCP) and regulatory requirements. Managed study timelines, budgets, and resources, and collaborated with various internal and external stakeholders to ensure successful trial delivery.

Ensured inspection readiness through meticulous documentation management, audit trail maintenance, and proactive quality oversight of clinical trial processes and systems.

Provided leadership and guidance to regional study teams, ensuring effective communication, milestone tracking, and trial-specific training across stakeholders.

Led global clinical trial operations across all phases (I–IV), ensuring on-time, on-budget, and high-quality execution aligned with ICH-GCP, regulatory standards, and corporate SOPs.

Oversaw CRO and vendor performance, including site management, clinical monitoring, TMF oversight, and data management deliverables to ensure alignment with project milestones.

Collaborated with cross-functional teams (medical affairs, regulatory, biostatistics, safety) to drive protocol development, feasibility, site selection, and start-up activities.

NOVO NORDISK, INC., Princeton, NJ 06/2013 – 06/2016

Pharmaceutical company.

Clinical Research Associate

Responsible for managing clinical trial sites, ensuring compliance with protocols and regulations, and supporting study teams. Responsibilities included site selection, initiation, monitoring, and close-out activities, as well as maintaining accurate records and communicating with stakeholders.

Managed site selection, initiation, monitoring, and close-out activities across multiple trial sites, ensuring compliance with GCP, ICH, FDA regulations, and internal SOPs.

Prepared and reviewed regulatory submissions, IRB documents, informed consent forms (ICFs), and trial master files (TMF) to support study start-up and ongoing compliance.

Served as primary liaison between clinical sites and internal stakeholders, resolving operational issues, supporting site readiness, and ensuring green-light approvals.

Oversaw vendor and CRO deliverables to ensure timelines and budgets were met; maintained tracking systems and reported on study metrics.

Participated in investigator meetings, trial team meetings, and cross-functional collaborations to support efficient trial execution and quality data collection.

MERCK, INC., Rahway, NJ 02/2012 – 01/2013

Pharmaceutical company.

Regulatory Manager

Responsible for preparing and managing documentation, coordinating with regulatory agencies, and ensuring ongoing compliance. Played a key role in product development, testing, manufacturing, and marketing, and focused on patient safety and efficacy.

Supported global regulatory submissions, including NDAs, PSURs, SBRs, and annual reports for both new and in-line product filings.

Prepared e-dossiers and responses to health authority (HA) inquiries, and contributed to filing strategies for post-approval changes.

Collaborated with regulatory agencies, internal scientists, and registration managers to ensure compliance with global regulatory requirements.

Maintained up-to-date records of manufacturing and testing procedures using internal tracking systems.

Participated in SPMT meetings and pre- and post-filing strategy discussions to align regulatory actions with global timelines and commitments.

FOREST RESEARCH INSTITUTE, INC., Jersey City, NJ 11/2009 – 11/2011

Pharmaceutical company.

Sr. Clinical Trial Associate

Responsible for supporting clinical trials and ensuring they were conducted efficiently and ethically. Assisted clinical research associates (CRAs) and project managers with various tasks throughout the trial lifecycle.

Supported study start-up through investigator evaluation, regulatory document collection, ICF review, and IRB submissions.

Managed trial documentation, including TMF, CTMS entries, and regulatory trackers; ensured accuracy and completeness of key site documents (1572s, CVs, licenses, financial disclosures).

Coordinated site activation, vendor communications, and drug and equipment logistics, served as primary point of contact for protocol questions and monitoring reports.

Conducted co-monitoring visits and source document verification (SDV); maintained oversight of CRO and site operations and compliance with GCP, SOPs, and FDA requirements.

Participated in NDA submissions, FDA Module 1 prep, and inspection readiness activities; supported training, vendor onboarding, and cross-functional team meetings.

PEARL THERAPEUTIC, INC., Morristown, NJ 01/2009 – 06/2009

Pharmaceutical company.

Sr. Clinical Trial Associate

Responsible for providing comprehensive support for clinical trials, managing documentation, coordinating activities, and ensuring regulatory compliance. Assisted with training, troubleshooting, and ensuring execution and adherence to regulations.

Supported investigator selection, site start-up, and IRB approvals for early-phase respiratory studies; managed ICF review and regulatory documentation.

Collaborated with CROs and vendors (labs, ECG, recruitment) to ensure timely study progress and protocol compliance.

Oversaw trial master file (TMF) maintenance, site communications, and supply management; participated in database lock and query resolution.

Conducted PFT data checks and site monitoring; attended investigator meetings and weekly study calls to report on status and site performance.

SCHERING PLOUGH RESEARCH INSTITUTE (MERCK), Kenilworth, NJ 01/2007 – 12/2008

Pharmaceutical company.

Clinical Project Specialist

Responsible for supporting all phases of clinical study activities (feasibility, start-up, conduct, and close-out) under the direction and supervision of study clinical operations lead(s). Planned, supported, created, and communicated clinical study timelines. Gathered input from cross-functional teams and created plans that helped the team produce deliverables on schedule.

Managed study start-up activities, regulatory document review, IRB approvals, and ICF tracking for global Phase III trials.

Maintained study timelines, budgets, and site grant payments in collaboration with CRAs and research finance.

Supported drug supply planning and logistics, including tracking shipments, managing expirations, and coordinating re-supplies.

Monitored enrollment, provided status updates to management, and flagged potential delays or grant-related issues.

Attended investigator meetings, managed vendor and CRO interactions, and supported the DQR process and TMF maintenance.

Created and maintained tracking tools and reports; participated in new employee onboarding and training.

FOREST RESEARCH INSTITUTE, INC., Jersey City, NJ 01/2002 – 10/2007

Pharmaceutical company.

Clinical Project Assistant

Responsible for supporting clinical trials and ensuring they were conducted efficiently and ethically. Assisted clinical research associates (CRAs) and project managers with various tasks throughout the trial lifecycle.

Managed study start-up files, regulatory document filing (1572s, CVs, licenses, financial disclosures), and maintained site regulatory binders.

Coordinated meetings, managed schedules, and handled travel arrangements for the AD and CTM teams.

Prepared and distributed newsletters, SAE reports, and mail merge letters to investigation sites.

Supported the preparation of PowerPoint presentations, Excel spreadsheets, and study status reports.

Monitored and tracked team schedules, invoices, and study progress; maintained databases for protocols and investigator lists.

Processed study-related supplies and invoices and provided ad hoc support for assigned projects.

Managed investigator meetings, site communications, drug supply logistics, and vendor payments.

Reviewed CRFs, informed consents, and site regulatory packages; ensured GCP and ICH compliance.

Co-monitored PSSV and SIV visits, supported site monitoring, and maintained tracking for enrollment, study status, and essential documents.

Led study start-up coordination, regulatory submissions (IRB/IEC, CTA, MoH), contract management, and site document collection.

Oversaw TMF setup, quality review, and reconciliation; managed CROs during trial conduct and close-out.

Reviewed protocol deviations, CAPAs, incident reports, and DCFs; supported data cleaning, database lock, and UAT testing.

Education

Master of Arts (MA), Healthcare Administration, Ashford University, Clinton, Iowa (01/2012)

Bachelor of Arts (BA), cum laude, Psychology & Sociology, Ashford University, Clinton, Iowa (01/2010)

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