JENNY CAROLINA CASTELLANOS
Clinical Research Associate
Carrera 2A 17A-34 Interior 6 Apartamento 102
Summary
With over a decade of experience in clinical research, I am a passionate and professional individual dedicated to the development, management, and monitoring of clinical trials while ensuring strict compliance with GCP regulations. Currently seeking a position within a research-oriented organization to effectively apply extensive knowledge and expertise, while making valuable contributions to the organization's overall success.
Overview
15
15
years of professional experience
11
11
years of post-secondary education
Work History
Senior CRA
Syneos Health
Bogota, Colombia
10.2023 - 12.2024
- Site management for oncology protocols.
- Site initiation and interim monitoring ensuring regulatory, ICH-GCP and protocol compliance.
- Verification of obtaining informed consent process has been adequately performed and documented for each subject as required/appropriate.
- Diligence in protecting the confidentiality.
- Site processes assessment.
- Source Document Review of appropriate site source documents and medical records.
- Issuing, verifying and resolving queries remotely and on-site, providing guidance to site staff as necessary.
- Verification site compliance with electronic data capture requirements.
- Investigational product inventory, reconciliation and reviews storage and security.
- Verification the investigational product has been dispensed and administered to subjects/patients according to the protocol
- Investigator Site File review for accuracy, timeliness and completeness.
- Reconciliation of contents of the ISF with the Trial Master File (paper and electronic).
- Documentation of activities via confirmation letters, follow-up letters, trip reports, monitoring reports, and other required project documents as per SOPs and Monitoring Plan.
- Supports subject/patient recruitment, retention and awareness strategies.
- Skilled at working independently and collaboratively in a team environment.
- Organized and detail-oriented with a strong work ethic.
- Participated in team projects, demonstrating an ability to work collaboratively and effectively.
CRA II
ICON (before PRA Health Sciences)
Bogota, Departamento del Huila
07.2016 - 10.2023
- CRA II with site management and protocols for nephrology, cardiology, oncology and endocrinology, implementation and monitoring clinical trials to ensure sponsor and investigator obligations are being met and are compliant, evaluation the qualification of potential investigative sites, opening clinical trials at investigative sites, instruct site staff on the proper conduct of clinical trials, closing clinical trials at sites, review and verify accuracy of clinical trial data collected, either onsite or remotely, provide regular site status information to team members, trial management, and update trial management tools, performs essential document site file reconciliation, perform source document verification and query resolution, accountability IMP and compliance at the investigative sites, verify Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines, update applicable tracking systems
- Self-motivated, with a strong sense of personal responsibility.
- Excellent communication skills, both verbal and written.
- Managed time efficiently in order to complete all tasks within deadlines.
CRA I
JSS Medical Research
Bogota, Departamento del Huila
12.2014 - 06.2016
- CRA I with management sites and infectology protocol, assesses the qualification of potential investigative sites, perform initiation visits, perform site visits in compliance with SOPs, conduct routine site contacts, review and verify eCRF and other clinical data for completeness and accuracy, generate queries and manage resolutions with site personnel, maintain project tracking systems, performing administrative tasks, perform essential document site file, assesses investigational product accountability, dispensation and compliance at sites, confirms investigative sites are following ICH/GCP guidelines
Respiratory Therapist
Centro De Investigaciones Medplus Medicina Prepagada
07.2013 - 01.2015
- Performing pulmonary function tests (spirometry) and review of criteria for clinical studies
Study Coordinator
Fundacion Santa Fe De Bogota
06.2013 - 12.2014
- Coordination of clinical studies (cardiology - infectology - hematology), patient´s recruitment that satisfy the inclusion and exclusion criteria established for the protocol, management of confidential documents, clinical record and personal information of the patients, elaboration of documents for Local Ethics Committee
- Fill out information in CRF in the established times and complying with the good practice clinical
- Management of IVRS, evaluation of adherence of study medication; coordination of visits at time according to protocol, strict monitoring of times in the procedures in the visits
- Control of each protocol and protection of confidential documents until the protocol end
Study Coordinator
Neumoinvestigaciones Ltda
03.2011 - 06.2013
- Preparation of technical pulmonary function tests with requirements of ATS
- Coordination of clinical studies (pneumology), management of confidential documents, clinical record and personal information of the patients, elaboration of documents for local Ethics Committee
- Fill out information in CRF in the established times and complying with the good practice clinics
- Management of IVRS, dispensation, and evaluation of adherence of study medication
Respiratory Therapist
Hospital San Blas
01.2010 - 12.2011
- Attend of pediatric, neonatal and adult patients in hospitalization, intermediate care, emergency, evaluation of risk and benefits in the clinical evolution
- Attend the patients in rehabilitation process, creation of exercises of rehabilitation that improve the life quality
Respiratory Therapist
Hospital Universitario Clinica San Rafael
Bogota, Colombia
06.2010 - 04.2011
- Attend of neonate patient in critical situation, control and use of ventilator strategies in Critical Intensive Care, evaluation of risk and benefits in the clinical evolution
Education
English Course -
Centro Colombo Americano
Bogota 02.2025 - Current
English Course -
Universidad Nacional De Colombia
Bogota 07.2017 - 06.2019
Epidemiology -
Fundacion Universitaria Del Area Andina
Bogota 02.2011 - 07.2013
Respiratory Therapist - Health Sciences
Universidad Manuela Beltran
Bogota 01.2005 - 07.2009
Technical Nurse - Health Sciences
Escuela De Salud Fusdesa
Bogota 01.2001 - 07.2003
Skills
- Protocol development
- Good Clinical Practice
- Clinical ethics
- Site management
- Leadership
- Technical Proficiency
- Friendly, positive attitude
- Teamwork and collaboration
- Microsoft office
- Problem-solving
- Excellent communication
Professional References
- Amanda Lucia Medina. Country Head at Bayer, 3153596328
- Alba Dayana Orjuela Ovalle. Clinical Research Manager at MSD, 3202162409
- Ana Maria Castro Cetina. Clinical Team Lead at ICON, 3168741921
Timeline
English Course -
Centro Colombo Americano
02.2025 - Current
Senior CRA
Syneos Health
10.2023 - 12.2024
English Course -
Universidad Nacional De Colombia
07.2017 - 06.2019
CRA II
ICON (before PRA Health Sciences)
07.2016 - 10.2023
CRA I
JSS Medical Research
12.2014 - 06.2016
Respiratory Therapist
Centro De Investigaciones Medplus Medicina Prepagada
07.2013 - 01.2015
Study Coordinator
Fundacion Santa Fe De Bogota
06.2013 - 12.2014
Study Coordinator
Neumoinvestigaciones Ltda
03.2011 - 06.2013
Epidemiology -
Fundacion Universitaria Del Area Andina
02.2011 - 07.2013
Respiratory Therapist
Hospital Universitario Clinica San Rafael
06.2010 - 04.2011
Respiratory Therapist
Hospital San Blas
01.2010 - 12.2011
Respiratory Therapist - Health Sciences
Universidad Manuela Beltran
01.2005 - 07.2009
Technical Nurse - Health Sciences
Escuela De Salud Fusdesa
01.2001 - 07.2003
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