Ingrid Carolina Carolina Díaz Córdoba
Bogotá,DC
Summary
Experienced nurse with 14+ years in Clinical Research. Started as an Unblinded Vaccinator and Study Coordinator at a Clinical Research Site, gaining hands-on experience. Transitioned to Clinical Trial Assistant role in a Clinical Research Organization (CRO), honing skills in managing trial documentation and ensuring regulatory compliance. Progressed to Clinical Research Associate (CRA), conducting on site and remote visits in Colombia, Mexico, Chile and Costa Rica for monitoring data, and ensuring protocol adherence. Also served as a Clinical Trial Manager for one year, overseeing trial operations and coordinating with cross-functional teams.
Overview
14
14
years of professional experience
Work History
Sr CRA II
Syneos Health
03.2022 - Current
- Same job description for Sr CRAI plus:
- Provide input into Requests for Proposals (RFPs), scope and budgeting
- Develop site management strategy
- Participate in Case Report Form design and edit check development
Sr CRA I
Syneos Health
10.2018 - 03.2022
- Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance
- Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans
- Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate
- Demonstrates diligence in protecting the confidentiality of each subject/patient
- Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
- Per the Clinical Monitoring/Site Management Plan (CMP/SMP):
- Assesses site processes
- Conducts Source Document Review of appropriate site source documents and medical records
- Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records
- Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
- May perform investigational product (IP) inventory, reconciliation and reviews storage and security
- Verifies the IP has been dispensed and administered to subjects/patients according to the protocol
- Verifies issues or risks associated with blinded or randomized information related to IP
- Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness
- Reconciles contents of the ISF with the Trial Master File (TMF)
- Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations
- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan
- Supports subject/patient recruitment, retention and awareness strategies
- Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution
- Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met
- Must be able to quickly adapt to changing priorities to achieve goals / targets
- May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate
- Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements
- Prepares for and attends Investigator Meetings and/or sponsor face to face meetings
- Participates, and may, with supervision, lead, global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions
- May provide training or mentorship to more junior level CRAs
- May perform training and sign off visits for junior CRA staff, as assigned
- May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager
- For Real World Late Phase (RWLP), the Sr
- CRA I will use the business card title of Sr
- Site Management Associate I
- Additional responsibilities include:
- Site support throughout the study lifecycle from site identification through close out
- Knowledge of local requirements for real world late phase study designs
- Chart abstraction activities and data collection
- As required, collaborate and build relationships with Sponsor and other affiliates, medical science liaisons and local country staff
- The SMA II may be requested to train junior staff
- Identify and communicate out of scope activities to Lead CRA/Project Manager
- Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations
- Identify operational efficiencies and process improvements
- Develop country level informed consent forms
- Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared
- Participate in bid defense meetings
Clinical Research Associate II
Syneos Health
09.2016 - 10.2018
- Perform site qualification, site initiation, interim monitoring, and close-out visits ensuring regulatory and protocol compliance
- Visits may be performed on-site or remotely
- Review completion of proper informed consent procedures
- Ensure accurate data reporting via review of site source documents and medical records
- Interpret data to identify protocol deviations and risks to subject safety/data integrity
- Generate queries and manage resolutions with site personnel
- Perform investigational product accountability as per the protocol and Study Monitoring Plan
- Evaluate execution of study protocol at the site level
- Use judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicate/escalate serious issues to the project team
- Obtain, review, and process essential regulatory and administrative documents
- Conduct audits of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance
- Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documents as per SOPs and Study Monitoring Plan
- Understand project scope, budgets, and timelines; manage site-level activities / communication to ensure project objectives, deliverables and timelines are met
- Must be able to quickly adapt to changing priorities to achieve goals / targets
- Act as primary liaison with study site personnel
- Enter data into tracking systems as required
- Participate in the identification and selection of investigators and clinical sites
- Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; complete assigned training as required
- Provide clinical and technical support for project team as required
Clinical Research Associate I
ICON Clinical Research
01.2015 - 09.2016
- Identify, select, initiate, and close-out appropriate investigational sites for clinical studies
- Monitor those sites in order to ensure that studies are carried out according to the study protocol, Company requirements, applicable regulations and the principles of ICH-GCP
- Involvement, when required, in other areas of study management and staff training and contribute to the review of Company systems and procedures as appropriate
- Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues
- Coaching and mentoring of monitoring competence to inexperienced/less experienced colleagues
- Independently and proactively coordinate the necessary activities required to set up and monitor a study
Clinical Trial Assistant
ICON Clinical Research
02.2013 - 12.2014
- To assist the Clinical Research Teams in ensuring the most effective and efficient conduct of Clinical Research studies by providing administration and project tracking support
Study Coordinator
CAIMED
01.2011 - 02.2013
- To coordinate and manage Clinical Protocols and associated activities
- Support in project planning and ensure that pre-established work scope, study protocol, and regulatory requirements are followed at site
- Recruits and schedule research subjects, as appropriate, and serves as principle administrative liaison for the project
- Develops and maintains recordkeeping systems and procedures
- Management compliance oversight for Study Visits per protocol requirements
- Facilitator of proper CRF completion and source documents verification, responsible for resolution of data queries, reviewing regulatory documentation and performing drug accountability
Un-blinded Vaccinator
CAIMED
10.2010 - 02.2013
- Oversees and coordinates Unblinded Part of the Clinical Research Protocol
- Plans and organizes the daily operations of the Investigational Product including the temperature records, inventory, destruction and randomization
- To ensure and take care of the Study Blinded part
Education
Diplomate - Fundamentals in Bioethics
Dasein - Colombia
01.2023
Specialization - Quality Management Health
Universidad Colegio Mayor de Cundinamarca
01.2019
Diplomate - Clinical Research and Drug development
Universidad Colegio Mayor De Cundinamarca
01.2017
Bachelor of Science Degree - Registered Nurse
Universidad Nacional De Colombia
01.2010
Skills
- Clinical Research Associate
- Registered Nurse
- Clinical trial management
- Project management
- Good clinical practice
- Remote monitoring capabilities
- Site monitoring expertise
- Teamwork oriented
LNGG
Spanish (Native)
Proficient
C2
English (verbal and written)
Advanced
C1
References
Ø José Luis Torres Cuadros.
Sr Clinical Study Manager at Medpace.
Mobile: (52) 5532625205
Ø Natalia Bustelo
Manager. Syneos Health
Mobile: (54) 91156623597
Timeline
Sr CRA II
Syneos Health
03.2022 - Current
Sr CRA I
Syneos Health
10.2018 - 03.2022
Clinical Research Associate II
Syneos Health
09.2016 - 10.2018
Clinical Research Associate I
ICON Clinical Research
01.2015 - 09.2016
Clinical Trial Assistant
ICON Clinical Research
02.2013 - 12.2014
Study Coordinator
CAIMED
01.2011 - 02.2013
Un-blinded Vaccinator
CAIMED
10.2010 - 02.2013
Specialization - Quality Management Health
Universidad Colegio Mayor de Cundinamarca
Diplomate - Fundamentals in Bioethics
Dasein - Colombia
Diplomate - Clinical Research and Drug development
Universidad Colegio Mayor De Cundinamarca
Bachelor of Science Degree - Registered Nurse
Universidad Nacional De Colombia
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