Summary
Overview
Work History
Education
Skills
Languages
Timeline
Generic

Aleida Garcia

Mahwah,New Jersey

Summary

Clinical Research Coordinator with a track record of success in participant enrollment and regulatory compliance. Expertise in study protocol execution, prioritizing participant safety, and maintaining confidentiality, contributing to successful trial outcomes.

Overview

34
34
years of professional experience

Work History

Clinical Research Coordinator

TKL Research Inc.
02.2023 - Current
  • Coordinate assigned clinical research trial from beginning to end under the direction of the Principal Investigator, Sub-investigator, and Clinical Trial Project Manager
  • Interact with sponsors as needed
  • Ensure that the regulatory binders are complete and up-to-date.
  • Execute and adhere to the clinical trial research protocols;
  • Performs follow-up procedures and completes case report forms;
  • Assist in the preparation of documents for IRB submission in compliance with all local, state, and federal regulations.
  • Screens potential research patients for clinical research protocols and gathers data while maintaining patient confidentiality using Medrio, Medidata and DSG
  • Create and maintain enrollment logs for each trial from beginning to end
  • Collaborates with the cross functional team (pharmacist, nurses, lab personnel, phlebotomist, clinicians, PI, Sub-I, clinical management team, data management involved in the trial.
  • Communicate and resolve all the data queries as needed
  • Responsible for monitoring, and reporting patient safety, adverse events, serious adverse events, and protocol deviation to PI, Sub-I, Clinical Trial Management, and Regulatory Coordinator.
  • Provide timely and complete updates to study team members regarding changes to workflow or patient-related specific needs by the protocol or SOP
  • Provide training to new personnel on research protocols, and sponsor policies and procedures as they pertain to the conduct of the protocol, and of program SOPs.
  • Develop study tools, including but not limited to eligibility checklists, medication diaries, calendars, and flow sheets as required.

Assistant Clinical Research Coordinator

TKL Research Inc.
08.2021 - 01.2023
  • Assist the Clinical Research Coordinator in developing strategies for implementing study procedures in compliance with the study protocol.
  • Organize and maintain study participants research charts and other research documentation.
  • Conduct patient research visits in conjunction with nursing staff and physician, following written instructions per protocol.
  • Assist in coordinating the recruitment and enrollment of study participants.
  • Screen potential research patients for study eligibility and communicate research studies to eligible participants and obtain informed consent.
  • Assist in updating and maintaining clinical systems within project timelines; prepare, handle, distribute, file, and archive clinical documentation and reports; review study files periodically for accuracy and completeness; prepare, handle, and distribute Clinical Trial Supplies and maintenance of tracking information; track and manage Case Report Forms (CRFs), queries and clinical data flow.
  • Follow written directions and protocols precisely.
  • Multi-task for a variety of projects. Assists to determine methods and procedures on new assignments and may supervise the activities of other Clinical Services personnel (e.g., Laboratory and Medical Technicians/ Assistants, Administrative Assistants, and Recruiters.)
  • Prepare, distribute, and track Clinical Trial supplies.

Senior Clinical Assistant

TKL Research Inc.
03.2019 - 07.2021
  • Provide assistance to Assistant CRC, as requested, in:
  • Logging and preparing study materials (labeling products/weighing products, etc.) for study start-up
  • Assembling study files and paperwork, including schedules, source documents, Informed consents, Product Dispensing Logs, etc.
  • Performing study related tasks (Screening, Enrolling/Disqualifying, Randomizing subjects, applying study product, etc.)
  • Maintaining study product and material inventories
  • Miscellaneous duties, as necessary, in support of, Research Clinic Division and TKL business priorities and objectives
  • Provide hands-on staff training for study prep
  • Assists in the preparation and execution of clinical studies at each site

Clinical Assistant

TKL Research Inc.
10.2017 - 02.2019
  • Responsible for preparing products for application prior to study start
  • Responsible for applying and /or removing study products and / or patches on study subjects as per protocol specifications
  • Responsible for performing dermatological evaluations under the supervision of the Principal Investigator according to study specific protocol
  • Share responsibility for maintaining an orderly, organized and sanitary study area
  • Track and maintain an inventory of supplies in study exam rooms
  • Utilize specialized computer software to update study files
  • Perform miscellaneous clinical and non-clinical duties upon request, as needed

Volunteer

Don Bosco Preparatory High School
09.2013 - 06.2017
  • Worked directly with the Vice-President of Institutional Advancement and the Director of Alumni Affairs and Special Events
  • Helped coordinate various events including but not limited to the Annual Don Bosco Prep Auction, Mother and Son Dance, Annual Football Gala, Annual Mother’s Guild Fashion Show, and the Multi-Cultural Night
  • Participated in school’s Open Houses and interacted with prospective students and their families helping them familiarize with the school from a parent’s perspective
  • Managed the ticket sales booth during football games
  • Orchestrated various fundraising events for the Youth Ministry Department’s Mission Trips to Haiti and Nicaragua
  • Maintained records of event aspects, including financial details.
  • Conducted post-event evaluations to determine how future events could be improved.
  • Developed and maintained solid relationships with vendors and sponsors

Clinical Research Recruiter Supervisor

Frontage Clinical Research Center
11.2010 - 04.2012
  • Responsible for recruiting subjects for all Clinical Research studies. This included, but not limited to, phone screening, radio, television, newspaper, and other printed advertising
  • Developed creative sourcing strategies for hard to fill studies including direct sourcing, internet recruiting, networking, utilization of external research, etc.
  • Developed strategic sourcing solutions to attract and acquire highly qualified patients.
  • Responsible for developing phone screening scripts per protocol specifics
  • Completed all paperwork associated with recruitment
  • Participated in health fairs to recruit subjects for clinical trials
  • Assisted with all literature and equipment needed for health expo’s
  • Responsible for maintaining accurate patient’s database
  • Organized and maintained all records required for recruitment for all clinical research studies
  • Attended Clinical Research startup meetings when required
  • Established a working relationship with the Clinical Research Coordinator

Human Resources Administrative Assistant

Frontage Clinical Research Center
08.2008 - 11.2010
  • Responsible for maintaining attendance employee’s attendance record for payroll
  • Assisted with the recruiting process through job posting, resume processing, reviewing, and scheduling interviews
  • Communicated with candidates regarding the status of their candidacy
  • Responsible for all incoming Verifications of Employment including background checks
  • Created and maintained personnel files
  • Responsible for processing all employees paper work including but not limited to disability, family leave, workman’s compensation, etc.
  • Prepared benefits enrollment
  • Collaborated with other departments to schedule orientation of all new hires
  • Responsible for coordinating activities designed to promote and maintain a high level of employee engagement, morale, and wellness under the direction of the HR Manager
  • Coordinated and communicated newly developed policies and procedure
  • Assisted with the day-to-day efficient operation of the HR office

Senior Travel Consultant/Office Manager

Tower Travel, LLC
08.2001 - 08.2008
  • Analyzed the clients’ specifications and wishes and suggest suitable travel packages or services
  • Organized travels from beginning to end, through booking tickets and accommodation, securing rental transportation etc.
  • Supplied travelers with pertinent information and useful travel/holiday material (guides, maps, event programs, etc.)
  • Collected deposits and balances
  • Used promotional techniques and prepared promotional materials to sell itinerary tour packages
  • Handled unforeseen circumstances and complaints and determined eligibility for money refunds
  • Attended conferences to maintain familiarity with tourism trends
  • Created and updated electronic records of clients
  • Maintained relationships with key persons
  • Kept client’s financial statements and documents
  • Responsible for managing a staff of five fulltime employees as well as six outside sales agents

Office Manager

Boulevard OB/GYN
11.1995 - 07.2001
  • Greeted and registered patients according to established protocols
  • Provided informative material for patients
  • Verified patients’ insurance information
  • Obtained health insurance verifications and precertification procedures.
  • Maintained medical and staff records
  • Developed and implemented office policies and procedures
  • Supervised office staff, including receptionists, secretaries, and medical assistants
  • Mediated with doctors and other staff members to identify potential office dysfunctions
  • Arranged cleaning staff and emergency maintenance services as necessary
  • Generated inventory records
  • Ensured compliance with current healthcare regulations, medical laws, and high ethical standards

Customer Relations Executive

Industrial Devices
07.1991 - 11.1995
  • Managed large volume of incoming calls
  • Identified and assessed customers’ needs to achieve satisfaction
  • Built sustainable relationships and trust with customer accounts through open and interactive communication
  • Provided accurate, valid and complete information by using the right methods/tools
  • Handled customer complaints, provided appropriate solutions and alternatives within the time limits; follow up to ensure resolution

Education

Bachelor’s Degree - Criminal Justice

Jersey City State College
Jersey City, NJ
05.1991

Skills

  • FDA guidelines
  • ICH-GCP standards
  • Electronic Data Capture (EDC) systems
  • Data entry
  • Data validation
  • Data maintenance
  • Participant screening
  • Participant enrollment
  • Communication
  • Rapport-building
  • Study protocol development
  • Data collection
  • Participant safety
  • Clinical trial coordination
  • Scheduling
  • Investigational product management
  • Study timeline oversight
  • Adverse event documentation
  • Regulatory compliance
  • Ethical research practices
  • Subject confidentiality
  • Courtesy
  • Empathy
  • Medical terminology
  • Microsoft Word
  • Microsoft Excel
  • Microsoft PowerPoint
  • Analytical skills
  • Detail-oriented
  • Problem solving
  • Flexibility
  • Pressure management
  • Multi-tasking
  • Written communication
  • Verbal communication
  • Interpersonal skills
  • Organizational skills

Languages

Spanish
Professional

Timeline

Clinical Research Coordinator

TKL Research Inc.
02.2023 - Current

Assistant Clinical Research Coordinator

TKL Research Inc.
08.2021 - 01.2023

Senior Clinical Assistant

TKL Research Inc.
03.2019 - 07.2021

Clinical Assistant

TKL Research Inc.
10.2017 - 02.2019

Volunteer

Don Bosco Preparatory High School
09.2013 - 06.2017

Clinical Research Recruiter Supervisor

Frontage Clinical Research Center
11.2010 - 04.2012

Human Resources Administrative Assistant

Frontage Clinical Research Center
08.2008 - 11.2010

Senior Travel Consultant/Office Manager

Tower Travel, LLC
08.2001 - 08.2008

Office Manager

Boulevard OB/GYN
11.1995 - 07.2001

Customer Relations Executive

Industrial Devices
07.1991 - 11.1995

Bachelor’s Degree - Criminal Justice

Jersey City State College

Similar Profiles

CREATE PROFILE