Director Clinical Research

MERCEDES MARTILLO-ZAPATA

** ********** ******, ********* ** · 201-***-****

*******@*****.*** · www.linkedin.com/in/mercedes-martillo

OBJECTIVE

A focused, detailed-oriented, and accomplished Clinical Research Professional with over 12+ years of experience facilitating the effective development and execution of essential clinical research programs across influential medical organizations. Possesses in-depth knowledge of rules and regulations, the IRB approval process, ability to collaborate with numerous departments to ensure effectiveness/compliance. Ample experience in Research involving wide range of Phase I-IV clinical trials medical, biologics, cosmetics, and investigational devices. Fluent in English and Spanish. Currently studying to obtain a Nursing degree.

SUMMARY

I am passionate about Research, and year over years I continue to find ways to increase my experience and education so I can help sites run efficient studies that will ultimately benefit vulnerable patients.

I have overseen hundreds of studies from Phase I to IV, in different therapeutic areas, from general medicine to Oncology, with a different kind of complexity, and with each of them, I have obtained the skills and expertise to manage and handle trials from start-up to close-out.

I possess strong interpersonal skills in managing day-to-day relationships with sites, sponsors, CROs, and the research team.

Every day I develop business plans, timelines, budgets, and contracts for research.

I create training and work on the improvement of the research operation for my company.

I work well independently and strive to provide the best performance, I recognize that successful clinical research requires constant collaboration and teamwork.

Managing clinical trials requires me to wear different hats which can include the oversight of clinical data, regulatory affairs, quality assurance, evaluation of staff and vendor performance.

I have the expertise and knowledge of GCP/ICH guidelines, local and federal regulations. Experience working on international studies which are required an understanding of the different regulatory construct.

EXPERIENCE

REGIONAL CANCER CARE ASSOCIATES LLC / RCCA MD LLC

05/2018 - Present

Hackensack, NJ / Director Clinical Research

Oncology trials, Phase I - IV

Oversee and be responsible for the day-to-day operations of the research department for the

entire network.

Continuously evaluates research program compliance, quality, and effectiveness identifies and

develops opportunities for improvement that provide greater value for stakeholders.

Develop study specific training documents.

Directing and implementing Clinical research plans and programs according to established

design principles.

Directs an effective system of marketing and communication across RCCA, the research

community, and key stakeholders, to build and promote a positive image of sponsored research.

Encourages expanded participation from existing physician investigators through action oriented

and expert support and helps to inspire and support new investigators in the sponsored research program.

Leads process improvement and organizational change initiatives toward program Optimization.

Maintain current knowledge of relevant regulations, including proposed and final rules.

Manage CRO’s and other vendors; monitoring and audit activities to ensure studies

compliance with GCP/ICH guidelines.

Organizes and structures RCCA research administrative services to expand the capacity of the

research program with a focus on increasing and diversifying sources of revenue and financial

support.

Participate in the development of the implementation of clinical trial documents.

Review and approval of study budget. Work with financial managers in the reporting and

accounting of the Research program fund.

Review and negotiate CDA and CTA for clinical studies.

Conduct quarterly performance reviews and continuous employee development.

Conducts site assessments visits to ensure research sites are implementing the study per the

protocol and to provide guidance for operational management.

Develop and lead the personal and professional development programs of clinical team

Personnel.

Develops and maintains a network of clinical and scientific contacts.

Identifies operational, logistical, and regulatory challenges related to the conduct of clinical

trials and acts as a leader in overseeing their resolution.

Proactively engages senior clinical management in program risk discussions and provides well thought out solutions to issues.

Provide a leadership role in developing, implementing, and evaluating the conduct of studies.

Provides in-service training and serves as a resource to other clinical personnel including

physicians, nurses, research coordinators, pharmacists, and other allied health professionals regarding clinical trials, protocols, GCP guidelines, federal regulations, and site SOPs.

Responsible for the recruitment and oversight of coordinator staff as well as ensure that the staff has completed mandatory training in a timely manner.

Develops and oversees a program specific onboarding and orientation process and participates in annual performance.

Evaluations and competency assessments of research staff.

Working with regulatory issues and the broader organization.

Travel to sites to create a working plan and implement a platform for new clinical research

Trials.

Responsible for leading Research Associates and Research Assistants in the day-to-day tasks

associated with identifying potential participants, scheduling screening and enrollment,

obtaining consent, administering measurement protocols, and ensuring participant retention.

Assist with the development and management of research subcontracts.

Assists Management with Business Development efforts.

Developing simple user interfaces for data entry, workflow management and querying.

Provides guidance to lower level personnel involved in planning, implementation and

evaluation of clinical studies.

Develop Training content for new personnel.

Arranging on-site visits and logistics.

Assists in evaluation of vendor performance during conduct of the study.

Conducting study site feasibility assessments and qualification visits.

Monitoring team performance against contract, customer expectations, and project baselines.

Serving as the primary project contact with the Sponsor (Customer).

UNIVERSITY OF CHICAGO

05/2021 - Present

Remote / Teaching Assistant (Bilingual)

Clinical Trials Program

Assist faculty with such tasks as lectures, data entry, exams, and tutoring

Being responsible for an entire undergraduate course

Observe other teacher lectures in the department and assist in writing supplementary lecture notes, answer keys and visual aids

Develop, write and proctor examinations, and then record and post grades outside the class location and online

Assist students with course material during office hours, and answer emails from students to ensure proper understanding of the course material

Serve as the administrator for the course discussion thread online and update the online course page with current due dates, assignments and class hours to make sure everyone has access to updated information

Acquire all materials needed for course instruction, including textbooks and various supplies to make sure instruction can fully proceed

HACKENSACK MERIDIAN HEALTH

01/2018 – 05/2018

Hackensack, NJ / Research Project Coordinator

Clinical Studies for the Center for Cancer Prevention and Control

Oversee and be responsible for the day-to-day operations of an assigned research project.

Responsible for leading Research Associates and Research Assistants in the day-to-day tasks

associated with identifying potential participants, scheduling screening and enrollment,

obtaining consent, administering measurement protocols, and ensuring participant retention.

Assists the principal investigator in developing the protocol budget, in collaboration with

Research Administration and the Grants and Contracts offices. Work with grant managers and

other financial managers in the reporting and accounting of these funds.

Develop and lead the personal and professional development programs of clinical team

Personnel.

Identifies operational, logistical, and regulatory challenges related to the conduct of clinical

trials and acts as a leader in overseeing their resolution.

TKL RESEARCH INC.

04/2015 – 05/2017

Fair Lawn, NJ / Senior Clinical Research Coordinator/ Project Manager

Dermatology, General medicine, Ophthalmology studies, Phase I - IV

Coordinate all clinical research activities with moderate supervision.

Responsible for overseeing and leading the work of the clinical research assistants, clinical

assistants, and lab technicians.

Responsible to train clinical staff, including Principal and Sub-Investigators on Study Protocols.

Responsible for planning and maintaining work systems, procedures, and policies that enable

and encourage the optimum performance of its people and other resources within the research.

Coordinates and administers research study associated activities.

Assists in project planning, and ensures that pre-established work scope, study protocol, and

regulatory requirements are followed.

Coordinate clinical studies from start-up to close-up.

Recruits and coordinates research subjects, as appropriate, and serves as principal administrative liaison for the project

Oversees and coordinates the provision of administrative and staff services to direct the investigators; develops and maintains recordkeeping systems and procedures.

Coordinate with data management related activities in the network.

Assists Management with Business Development efforts.

Identifies quality and performance improvement opportunities and collaborates with staff in

the development of action plans to improve quality.

SADICK RESEARCH GROUP

04/2014 – 04/2015

New York, NY / Clinical Research Manager

Dermatology; Phase II - IV

Supervise and mentor the Clinical Research Coordinators, Clinical Assistants, Medical Assistants and lab Technicians in conducting the Clinical Trials.

Ensure that all regulations and guidelines are being met.

Provide support, coordination, and leadership for drug/device studies that may involve

industry-sponsored Phase II, III, and IV clinical trials, government-funded clinical research,

and investigator-initiated clinical trials.

Ensure smooth, accurate progress of clinical studies from the planning and approval stages

through study completion and post-study closure.

Prepare documentation for submission for review by the Institutional Review Board (IRB).

Recruit and screen study participants, coordinate their clinical treatment and follow-up care,

and help facilitate their continued participation.

Abstract data from medical records and other sources; collect, submit and maintain study data

and regulatory documents.

Develop and ensure compliance with study protocols; and participate in the planning,

development, and budgeting for clinical studies.

Assists the principal investigator in preparing manuscripts for publication.

Conduct quarterly performance reviews and continuous employee development.

Identifies operational, logistical, and regulatory challenges related to the conduct of clinical

trials and acts as a leader in overseeing their resolution.

Responsible for the recruitment and oversight of coordinator staff as well as ensures that staff

has completed mandatory training in a timely manner.

Develops and oversees a program specific on-boarding and orientation process and participates in annual performance evaluations and competency assessments of research staff.

CAREPOINT HEALTH RESEARCH INSTITUTE

02/2013 – 03/2014

Jersey City, NJ // Senior Research Clinical Coordinator

Oncology, Cardiology, Endocrinology, Ophthalmology, Infections Diseases, Psychiatry,

Gynecology, General Medicine; Phase II-IV

Participated in the planning, implementation, and overall direction of clinical research

projects conducted on behalf of sponsors.

Performed study procedures to generate, evaluate, review and record study data, to transcribe

source data to the case report forms.

Liaise with sponsor personnel.

Maintain a high level of professional expertise through familiarity with the study protocol,

investigator's brochure, and related study materials, and to participate in project team meetings.

Develop budgets, prepared and submitted proposals to sponsors.

Review and negotiate Clinical Trial Contracts.

Assist the principal investigator in conducting clinical studies in compliance with applicable

regulations and GCP guidelines.

Assist with training of CRCs and other study personnel.

Creation and implementation of Research SOPs.

FRONTAGE LABORATORIES

07/2007 – 11/2012

Hackensack, NJ // Clinical Research Coordinator/ Medical Assistant

Participate in more than 100 Bioequivalence, Phase I and II studies

Responsible for working under the guidance of the Principal Investigator and Sub-Investigators, operations manager, and clinical research coordinators.

Participate in the planning, implementation, and overall direction of clinical research projects

conducted on behalf of sponsors at the Frontage Clinical Research Center.

Required to perform study procedures, to generate, evaluate, review and record study data, to

transcribe source data to case report forms.

Liaise with sponsor personnel, to maintain a high level of professional expertise through

familiarity with the study protocol, investigator's brochure, and related study materials, and to

participate in project team meetings.

Assisted the principal investigator in conducting clinical studies in compliance with applicable

regulations and GCP guidelines.

Assist in submissions and notifications to Ethics Committees and Regulatory Authorities.

Assist with the management of study supplies and organize shipments.

Assists in survey development, response tracking, data requests, prepares study materials, and

ensures protocol adherence.

Create Study related template documents.

Create, update, track, and maintain study-specific trial management files, tools, and systems.

Demonstrate attention to detail.

Ensure compliance with SOPs, FDA, ICH, and GCP regulations for clinical conduct in all

aspects of daily work.

Perform other administrative duties as assigned by management.

Provide clinical support for projects according to Standard Operating Procedures, ICH

Guidelines and GCP.

Update and maintain Clinical Development protocol number tracking log.

Works as part of the research team to provide support in coordinating the day to day activities

in the Department of Research.

EDUCATION AND MEMBERSHIP

PASSAIC COUNTY COMMUNITY COLLEGE

Nursing (In Progress)

2017 – 2020

ASSOCIATION OF CLINICAL RESEARCH PROFESSIONALS

Certified Clinical Research Coordinator

2013 – Present

Board Member – Content Committee

2021- Present

THE SOCIETY OF CLINICAL RESEARCH ASSOCIATES

Certified Clinical Research Professional

2012 – 2018

NATIONAL HEALTH ASSOCIATION

Clinical Certified Medical Assistant

2010 – 2019

FLIGHT SAFETY INTERNATIONAL ACADEMY

Air traffic Controller and Aircraft Dispatcher (Graduate)

2006 – 2008

VAUGHN COLLEGE OF AERONAUTICS

Aeronautics

2004 – 2006

SKILLS

Ability to attend to detail and be precise with the ability to work independently, exercising

judgment in establishing priorities.

Ability to prioritize quickly and appropriately.

Demonstrated strong attention to detail and ability to adhere to project deadlines.

Excellent organizational skills and attention to detail in maintaining accurate, retrievable records.

Knowledge of and ability to adhere to good clinical practices (GCP).

Strong leadership skills (scientific and business) and proven ability to coordinate and lead local and regional teams to high performance.

Strong project management skills.

Knowledge of Clinical Development Process

Ability to resolve routine issues effectively and independently.

Ability to multi-task and manage several projects in parallel, paying attention to detail.

Demonstrated ability to evaluate medical research data and proficient knowledge of medical terminology.

Project management experience including the ability to prioritize, plan & evaluate deliverables.

SPONSORS/CRO EXPERIENCE

Amarex Clinical Research

AstraZeneca

Axis Clinicals

BioProtect

Bristol-Myers Squibb

CCORN

Celgene

DFCI Harvard

Epizyme

Genentech

GSK

Incyte

IQVIA

Janssen

Merck

Mirati

Natera

Bayer

Boehringer Ingelheim Pharmaceuticals

Cartesian

Notable Labs

Optimal

Precision Cancer Research

Pharmatech/Caris

Rhizen Pharmaceuticals

Rigel

Sanofi

SecuraBio

Syneos

Tempus

Tersera

TG Therapeutics

Abbvie

Agios Pharmaceuticals

Amgen

Armo

Astellas

Astex

Tesaro

Astex

Bayer

Boehringer Ingelheim Pharmaceuticals

Cartesian Daiichi

Exelixis

Gilead

ICON

Ipsen

Elly Lilly

Novella

OncoTherapeutics

Parexel

Pfizer

PRA Health

Procure

PSI

Roche

Seattle Genetics

Shire

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