Carlos Lopez Jimenez
New York,NY
Overview
24
24
years of professional experience
Work History
Senior Clinical Research Associate
New York University Langone Health. Office of Science and Research
New York
07.2022 - Current
- Coordinate clinical trials for the Ophthalmologic division (ZEDS Trial), with responsibility for overall operations of the clinical sites; train Investigators, staff, and research coordinators; and maintain protocol adherence
- Collaborate with doctors, consultants, and investigators conducting trials, held responsible for preparing investigator meetings and preparing reports of protocol changes and site performance
- Protocol trains all Investigators and Coordinators
- Conduct site audits, verify data, monitor schedules, file and collate trial documentation and reports, archive study documentation and correspondence, and prepare final reports
- Prepare weekly meetings for the day-to-day operations of the study
- Prepare biannual or as-needed DSMC meetings as well as Executive and Steering Committees meetings
- Prepare Monthly meetings to update/report to the Leadership of the study, presenting metrics and up-to-date information
- Confirm authorizations of site payment
- Liaison between all vendors, such as PAREXEL, Omnicom, Q2, Icon, MAPI
- Close out all Participating Clinical Centers (PCCs) when the study's completion is confirmed
- This includes signing all forms by the Principal Investigator in the database (TrialMaster), sending/confirming the termination contract letter, and closing the Central or local IRBs
- Prepare and email a monthly newsletter using MailChimp with the current information of the trial with a target audience of 450 people
- Monthly Coordinator's Calls via Webex to keep Centers updated
- Onboard new staff at the Clinical Centers with Webex/Zoom meetings
- Certified new people on the protocol, WIRS, CTMS, and TrialMaster
- Create individualized accounts
- Responsible for collecting and sending the documentation to the Clinical Event Review Committee (CERC) to adjudicate primary endpoints
- Responsible for collecting and sending the documentation to the Medical Monitor to review SAEs.
Clinical Research Associate
New York University Langone Health. Office of Science and Research
New York
07.2017 - 07.2022
- Coordinate clinical trials for the Ophthalmologic division (ZEDS Trial), with responsibility for overall operations of the clinical sites; train staff and research coordinators; and maintain protocol adherence
- Collaborate with doctors, consultants, and investigators conducting trials, held responsible for preparing investigator meetings and preparing reports of protocol changes and site performance
- Conduct site audits, verify data, monitor schedules, file and collate trial documentation and reports, archive study documentation and correspondence, and prepare final reports.
Clinical Research Associate
Columbia University/ New York Presbyterian Hematology & Oncology
New York
11.2015 - 06.2017
- Coordinate clinical trials for hematology & oncology division, with responsibility for overall operations of the clinical site, training research coordinators, and maintaining protocol adherence
- Collaborated with doctors, consultants, and investigators conducting trials, held responsible for preparing investigator meetings, preparing reports of protocol changes and sites performance
- Conduct site audits, verify data, monitor schedules, file and collate trial documentation and reports, archive study documentation and correspondence, prepare final reports.
Program Coordinator of Northeast Network
Cardiac Clinical Trials Unit, Columbia University
New York
02.2011 - 11.2015
- Coordinated, organized, and maintained all operations of 12 clinical sites to maintain protocol adherence
- Trained research coordinators to communicate effectively with providers, and medical staff
- Designed specialized documentation for clinical research optimizing correct data captured
- Trained, supervised, and performed cognitive battery tests to participants
- Develop strong site relationships and ensure continuity of site relationships through the trial
- Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents
- Gains an in-depth understanding of the study protocol and related procedures
- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Readiness
- Participates & provides inputs on site selection and validation activities
- Performs remote and on-site monitoring & oversight activities using various tools
- Responsible for all study start-up and daily follow-up activities, including study protocol design and informed consent creation, site identification and assessment, IRB submission, patient screening/enrollment, etc
- Reviewed and evaluated that studies were conducted according to GLP/GCP guidelines and 21 CFR Part 50.
Program Coordinator of Columbia University Sites
Cardiac Clinical Trials Unit, Columbia University
New York
02.2011 - 11.2015
- NHLBI Trial, Systolic blood Pressure Intervention Trial (Sprint), responsible for coordinating three clinical sites and maintaining protocol adherence
- Performs remote and on-site monitoring & oversight activities using various tools
- Communicated effectively with families, providers, and medical staff to coordinate procedures set by appropriate protocol.
Program Coordinator of Northeast Network
Cardiac Clinical Trials Unit Columbia University
New York
01.2001 - 01.2011
- Coordinated, organized, and maintained all operations of 12 clinical sites to maintain protocol adherence
- Trained research coordinators to communicate effectively with families, providers, and medical staff
- Designed specialized documentation for clinical research, optimizing correct data captured
- Trained, supervised, and performed cognitive battery tests on participants
- Develop strong site relationships and ensure continuity of site relationships through the trial
- Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws and regulations, Protocol, Site Monitoring Plan, and associated documents
- Gains an in-depth understanding of the study protocol and related procedures
- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Readiness
- Participates & provides inputs on site selection and validation activities
- Performs remote and on-site monitoring & oversight activities using various tools
- Utilized WEBEX for conference and training calls
- Responsible for all study start-up and daily follow-up activities, including study protocol design and informed consent creation, site identification and assessment, IRB submission, patient screening/enrollment, etc
- Reviewed and evaluated that studies were conducted according to GLP / GCP guidelines and 21 CFR part 50.
Timeline
Senior Clinical Research Associate
New York University Langone Health. Office of Science and Research
07.2022 - Current
Clinical Research Associate
New York University Langone Health. Office of Science and Research
07.2017 - 07.2022
Clinical Research Associate
Columbia University/ New York Presbyterian Hematology & Oncology
11.2015 - 06.2017
Program Coordinator of Northeast Network
Cardiac Clinical Trials Unit, Columbia University
02.2011 - 11.2015
Program Coordinator of Columbia University Sites
Cardiac Clinical Trials Unit, Columbia University
02.2011 - 11.2015
Program Coordinator of Northeast Network
Cardiac Clinical Trials Unit Columbia University
01.2001 - 01.2011
Similar Profiles
JENNIFER STAPLETON RN, BSN, CCRNJENNIFER STAPLETON RN, BSN, CCRN
Registered Nurse/ Senior Nurse Clinician at New York University Langone HealthRegistered Nurse/ Senior Nurse Clinician at New York University Langone Health
Armin DhillonArmin Dhillon
ANESTHESIA TECHNOLOGIST at New York University Langone HealthANESTHESIA TECHNOLOGIST at New York University Langone Health
Justin JohnsonJustin Johnson
Medical Secretary at NYU Langone Health-New York, NYMedical Secretary at NYU Langone Health-New York, NY
Natali SharipashviliNatali Sharipashvili
Server / Food Expeditor at Rhubarb Hospitality Collection (RHC)Server / Food Expeditor at Rhubarb Hospitality Collection (RHC)
Gifty DavisGifty Davis
Billing Manager at Fish & Richardson, P.C.Billing Manager at Fish & Richardson, P.C.