Judith Talib
Atlanta,GA
Summary
Diligent Clinical Research Coordinator with comprehensive background in coordinating clinical research studies. Successfully managed multiple clinical trials from initiation to closeout, ensuring adherence to regulatory guidelines. Demonstrated ability to effectively communicate with cross-functional teams and maintain meticulous documentation. Experience in study areas including bone marrow transplants, oncology, sickle cell disease, immune dysregulation, gene therapy, and other blood disorders. Recognized for time management, sound problem-solving skills, and initiative.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator
Aflac Bone Marrow Transplant - Children's Healthcare of Atlanta
07.2022 - Current
- Completes all forms and correspondence and reports to the CROs and sponsors in a timely manner
- Primary responsibility is to screen, enroll, and follow study subjects ensuring protocol compliance and close monitoring while the subjects are on the study.
- Responsible for all data collection, source documentation, developing/completing study-specific case report forms and submission of adverse experience reports.
- Screens potential patients and targets specific study and enrollment goals.
- Meets with research team during routine visits to discuss case report form completion, query resolution and other protocol-related issues.
- Serves as an ambassador for principle investigators for new and upcoming research studies.
- Maintains accurate communication with study monitors and related study personnel.
- Obtains informed consent by following policy, procedure,a nd regulatory requirements.
- Maintains all licensure's, certifications, and system education requirements for role.
- Facilitates grants, contracts, and financial tasks for research and clinical trials.
- Supports Principal Investigator in study budgeting, sponsor interactions, routing, feasibility assessments, account management, and reconciliation.
- Schedules study-specific visits in conjunction with ancillary departments.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
- Oversaw the management of investigational product supplies, ensuring appropriate storage conditions were maintained at all times for optimal efficacy during trials.
Laboratory Research Coordinator
Children’s Healthcare of Atlanta
09.2021 - 07.2022
- Fulfilled research-only testing as required and applicable per study and system requirements
- Completed department approval forms and research processing budgets
- Provided research study education to internal staff as part of a study protocol
- Created, updated, and maintained weekly and monthly schedules for the research processing department
- Coordinated and communicated with various internal departments for the development of studies
- Served as an ambassador for principle investigators for new and upcoming research studies
- Maintained open lines of communication with internal and external staff
- Reviewed literature extensively to stay informed about industry trends and advancements in related fields of study.
- Gathered, processed, and shipped lab specimens.
- Managed multiple projects simultaneously, ensuring timely completion and high-quality results.
Senior Referral Testing Specialist (Clinical Research)
Children’s Healthcare of Atlanta
03.2021 - 09.2021
- Process and label research specimens for testing according to study protocol
- Prepare study kits for future study visits
- Knowledgeable of shipping standards of study specimens
- Create monthly invoicing for research studies
- Maintain training and competencies
- Ensure inventory of kit supplies are up to date and available
- Initiate and ensure positive and professional relations with clinical research staff
- Collaborated with cross-functional teams to ensure high-quality products were delivered on time.
- Enhanced test coverage through thorough identification of critical test scenarios.
- Improved testing efficiency by streamlining processes and implementing best practices.
- Devised and implemented updates and resolutions for handling risks, maintaining compliance and improving designs.
Specimen Processor
Children’s Healthcare of Atlanta
06.2013 - 03.2021
- Developed strong relationships with internal departments, facilitating smooth communication channels for expedited issue resolution regarding specimens or testing requirements.
- Reduced errors in specimen data entry through meticulous attention to detail and thorough review processes.
- Maintained a well-organized work environment by implementing effective storage and tracking systems for specimens.
- Streamlined specimen processing workflows to improve turnaround times and ensure timely delivery of results to clients.
- Assisted with processing of reference laboratory specimens
- Enhanced team knowledge and skills with regular training sessions on new processing techniques.
- Enhanced patient care by providing detailed documentation of specimen collection and processing steps.
- Oversee and document order errors
- Provided assistance in problem solving pertaining to patient specimens
- Initiated and ensured positive and professional relations with co-workers
- Followed safety protocols while handling hazardous materials.
- Ensured compliance with all relevant safety protocols while handling biohazardous materials during specimen processing tasks.
- Processed high volumes of time-sensitive specimens without compromising accuracy or quality standards under tight deadlines.
Specimen Accessioner
LabCorp (Radiant Systems, Inc.)
02.2013 - 05.2013
- Received specimens into laboratory information systems for shipment tracking
- Prepared and processed specimens for transport to designated laboratories
- Played a crucial role in meeting laboratory accreditation requirements, meticulously adhering to established protocols and providing accurate documentation as needed.
- Continuously improved knowledge of industry best practices by attending relevant trainings and workshops.
- Maintained a clean and organized work environment, adhering to safety protocols and standards.
- Expedited troubleshooting efforts for problematic samples, liaising closely with technical staff to achieve swift resolution and minimize impact on turnaround times.
- Enhanced laboratory productivity with timely accessioning of incoming specimens.
- Improved specimen processing efficiency by accurately labeling and organizing samples.
- Demonstrated adaptability in adjusting priorities according to changing demands while maintaining focus on accuracy and efficiency.
- Upheld high-quality service levels by promptly addressing any concerns raised during internal or external audits related to specimen handling processes.
- Trained and supervised junior technicians in laboratory protocols.
Laboratory Technician
Wishard Health Services
03.2011 - 12.2012
- Followed laboratory procedures to perform specimen handling and processing, including:
- Centrifugation
- Aliquoting specimens
- Packaging and tracking specimens designated for reference laboratories
- Ensured received specimens are appropriate for the testing order
- Complied with departmental and hospital policies and procedures
- Maintained a high level of accuracy in test results by following strict quality control procedures.
- Cleaned and sterilized tools and equipment to maximize purity of specimens.
- Operated basic laboratory equipment such as balances, pH meter, colorimeter, spectrophotometer, autoclave and evaporator.
- Maintained documentation on tests performed in lab.
- Performed testing and quality control using approved laboratory procedures and instrumentation.
- Provided assistance to laboratory staff and resolved patient problems and orders
- Calibrated and maintained instruments to keep equipment fully operational.
- Performed routine lab and department maintenance to keep area clean and orderly.
Education
B.A. - Biology
Purdue University
Indianapolis, IN01.2010
Skills
- Informed consent
- Adverse event reporting
- Study protocols
- Data collection techniques
- Participant screening
- Multitasking
- Medical Terminology
- Time management abilities
- Specimen handling
- Adverse event tracking
- Database organization
- Case report management
- Good clinical practice
- Multitasking Abilities
- Critical Thinking
- Team building
- Detailed documentation
Certification
- IATA Shipping and Transport of Dangerous Goods Certification – International Air Transport Association.
- Human Subjects Biomedical Research– CITI Program
- CPR/AED Certification
- Good Clinical Practice (GCP) and ICH- CITI Program
- Human Research (Social/Behavioral)- CITI Program
- Clinical Research Coordinator- CITI Program
- Conflicts of Interest- CITI Program
Computer Software
- EPIC
- Medidata
- RedCAP
- IBM
- RAVE
- CTMS
- OnCore
- Children's Oncology Group
- Advantage EDC
- Judi
- Florence
- SCOUT clinical
Timeline
Clinical Research Coordinator
Aflac Bone Marrow Transplant - Children's Healthcare of Atlanta
07.2022 - Current
Laboratory Research Coordinator
Children’s Healthcare of Atlanta
09.2021 - 07.2022
Senior Referral Testing Specialist (Clinical Research)
Children’s Healthcare of Atlanta
03.2021 - 09.2021
Specimen Processor
Children’s Healthcare of Atlanta
06.2013 - 03.2021
Specimen Accessioner
LabCorp (Radiant Systems, Inc.)
02.2013 - 05.2013
Laboratory Technician
Wishard Health Services
03.2011 - 12.2012
- IATA Shipping and Transport of Dangerous Goods Certification – International Air Transport Association.
- Human Subjects Biomedical Research– CITI Program
- CPR/AED Certification
- Good Clinical Practice (GCP) and ICH- CITI Program
- Human Research (Social/Behavioral)- CITI Program
- Clinical Research Coordinator- CITI Program
- Conflicts of Interest- CITI Program
B.A. - Biology
Purdue University
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