Carla Paulin
Mexico City
Summary
Detailed-Oriented Clinical Research Professional with 15+ years of experience, Proficient in Data analysis, Patient Recruitment & Retention Strategies. Skilled in Regulatory Compliance & Risk Based Monitoring, Passionate Mentor.
Overview
13
13
years of professional experience
1
1
Certification
Work History
SR. CLINICAL SITE MANAGER
Alcon Laboratorios
05.2018 - Current
- Conducting study visits (site selection, initiating, monitoring, close out), remote/on-site; in USA, CAN and LACAR region
- Accomplish critical study milestones, within thigh deadlines
- Mentoring Jr. CSM team
- Leading projects as part of innovation and quality company values.
- Coordinating patient recruitment strategies and retention plan, reaching target goal
- Reviewing and Improving study visit reports metrics, decreasing 50% on timelines of completion/review
- Negotiating Site contracts budget
- Developing new GCP foundations training for new site staff.
- Collaborate in creating new tools to make easier site selection and regulatory timelines.
- Identifying, analyzing and presenting potential risks through internal metrics reports for site selection process to develop CAPAs to mitigate/resolve risks identified.
- Making decision-informed of potential investigators/sites based on their performance, referrals, metrics.
- Implemented process improvement to shape organizational culture, optimize procedures for higher efficiency and help company evolve and grow.
- Provided detailed project status updates to stakeholders and executive management.
- Working in multicultural environment
SR. CLINICAL RESEARCH ASSOCIATE
DOCS Global
09.2016 - 11.2017
- Conducting monitoring activities across all study phases and stages
- Conducting initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Data informed based on company data bases, and support sites in developing subject recruitment/retention strategies for oncology studies.
- Followed drug storage procedures to comply with protocols and SOP requirements.
- Managed project risk by identifying and monitoring potential threats through data analysis
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
- Working with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
CLINICAL RESEARCH ASSOCIATE I & II
PRA Health Sciences
05.2012 - 09.2016
- Conducting feasibility visits and reports based on company data bases, and support sites in developing subject recruitment/retention strategies for pediatric and adult population studies in different therapeutic areas
- Participating in a pilot feasibility team, to identify potential sites analyzing data to select best group for an specific study.
- Leading internal meetings to coordinate feasibility process, like surveys, collaborating with other areas, etc.
- Develop CAPA Process and analyze data to identify trends, risks at sites to improve site performance
- Mentoring Jr CRA team
- Review monitoring visit reports
- Acting as Interim Project lead and Lead CRA for some studies assigned
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Followed drug storage procedures to comply with protocols and SOP requirements.
COORDINATOR OF BIOMEDICAL RESEARCH DEPARTMENT & IRB COORDINATOR
Medica Sur Hospital
07.2010 - 04.2012
- Coached employees through day-to-day work and complex problems.
- Entered data, generated reports, and produced tracking documents for IRB organization
- Set priorities and problem-solved workflow issues to maintain rapport with customers and managers.
- Gathered and organized materials to support operations.
- Improve internal process to increase quality on documentation, reduce timelines for reviewing, discussing and provide comments/approve clinical protocols
- Implement mandatory training for health professionals within the Hospital Collaboration.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Hired, managed, developed and trained staff, established and monitored goals, conducted performance reviews for staff.
- Followed informed consent processes and maintained records.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Gathered, processed, and shipped lab specimens.
- Directed, guided, and delegated tasks to teams and developed project schedules, resource requirements and timelines to maintain productivity on goals and objectives.
- Implemented electronic data capturing QC checks to adhere with clinical research guidelines.
- Working with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Collaborating as Editor in Annals of Hepatology Journal and Medica Sur Journal
Education
Master of Bioethics (MBE) -
Instituto Politécnico Nacional
Mexico02.2012
Bachelor of Science - Pharmaceutical Sciences
Universidad Nacional Autónoma De Mexico (UNAM)
Mexico2004
Skills
- Detailed oriented
- Power BI
- Analytical Thinking
- Data Informed & Data Analysis
- Team Leadership
- Quality Assurance & Regulatory Compliance
- Problem-Solving
- Process Improvement
- Flexibility and Adaptability
- SOP Development
- Skilled in Office Suite
- Proficient in Veeva Vault, CTMS, Medidata
- Staff Training
- Problem Solving
Certification
- ICH-GCP, 2023
- Empathetic communication, 2022
- ISO 13485
- Risk Based Monitoring
- Electronic Data Capture, CTMS, ePRO, TMF systems
- Assertive Communication
- Advanced Excel Certificate (On process)
Affiliations
Association of Clinical Research Professionals - ACRP
Hobbies & Interests
As a mindfulness facilitator and practitioner, I am dedicated to promoting mental well-being and personal growth. I also have passion for travel , which allows me to explore diverse cultures and broaden my perspective. Also, I have a keen interest in digital marketing , constantly seeking opportunities to enhance my skills. I am a dedicated self-learner , always seeking new knowledge and skills to further my personal and professional development.
Additional Information
With over my 15 years of experience, I have developed expertise in data analysis, patient recruitment, and retention strategies, as well as regulatory compliance and risk based monitoring. I am also a dedicated mindfulness facilitator and practitioner also I am seeking new knowledge and skills that reflect my continuous pursuit of personal and professional development.
Languages
English
Bilingual or Proficient (C2)
Timeline
SR. CLINICAL SITE MANAGER
Alcon Laboratorios
05.2018 - Current
SR. CLINICAL RESEARCH ASSOCIATE
DOCS Global
09.2016 - 11.2017
CLINICAL RESEARCH ASSOCIATE I & II
PRA Health Sciences
05.2012 - 09.2016
COORDINATOR OF BIOMEDICAL RESEARCH DEPARTMENT & IRB COORDINATOR
Medica Sur Hospital
07.2010 - 04.2012
Master of Bioethics (MBE) -
Instituto Politécnico Nacional
Bachelor of Science - Pharmaceutical Sciences
Universidad Nacional Autónoma De Mexico (UNAM)
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