Tanya Goudeau
Overland Park,KS
Summary
Experienced clinical data coordinator with a proven track record of delivering accurate and high-quality data for clinical research studies. Skilled in coordinating with clinical research teams, ensuring compliance with regulatory bodies, and collaborating with multi-disciplinary groups to collect and manage data.
Overview
17
17
years of professional experience
Work History
Senior Clinical Data Coordinator
KU Cancer Center
12.2021 - Current
- Accurately capture subject information into various study-specific data capture systems (electronic and paper) in a timely manner.
- Perform reconciliation of source documentation and data entry within multiple clinical databases and information systems to support data quality and the data management plan.
- Complete SAEs, adverse event reports, and disease response assessments according to protocol.
- Review and process clinical trial data to ensure completeness, accuracy, and consistency.
- Collaborate with a multi-disciplinary group to coordinate and collect data for clinical trials.
- Participate in training sessions for assigned protocols, study initiation meetings, and internal kick-off meetings.
- Manage and assist with assigned monitor and audit visits with the QA team.
- Research and resolve data discrepancies in a timely manner, and provide sufficient, appropriate, and timely responses to sponsor verbal and written queries.
- Coordinate final study closure activities, participate in audits and process improvement initiatives, and provide training for new Clinical Data Coordinators to ensure they are equipped with the necessary skills and knowledge to perform their roles effectively.
- Adhere to protocol data collection related to billing activities to maintain timely data reporting, resolve and answer data queries from sponsors, perform data analysis, document verification for protocol compliance and drug accountability, and coordinate preparation of data for audits and monitoring visits.
Senior Laboratory Coordinator
KU Cancer Center
08.2017 - 12.2021
- Prepared and validated buffers and in-house reagents, calibrators, and controls in advance of laboratory testing and analysis orders.
- Collected blood and tissue samples with focus on accuracy and adherence to aseptic techniques.
- Performed routine shipments of samples collected from patients participating in clinical trials and provided results to the Clinical Pharmacology Shared Resource as well as principal investigators.
- Collaborated and assisted with routine sponsors and monitors visits.
- Performed basic laboratory skills including calibration and use of balances, pipettes, centrifuges, and sample evaporators.
- Collaborated with Clinical Laboratory, Clinical Trial Office, and Clinical Pharmacology Unit staff to ensure transfer and processing of samples, data analysis, and communication of results in a timely manner.
- Ensured all requirements for sample integrity have been met (positive identification of patient, visit, and time; traceable records from sample transfer through final data delivery, etc.)
- Recognized sources of error in sample identification, processing, or analysis and initiated corrective action when indicated.
- Performed high complexity testing by preparing specimens for analysis and maintaining assay quality.
- Prioritized work assigned, maintained accurate records of work performed and initiated corrective action in case of defective records or inadequate care plans.
- Developed and implemented standard operating procedures to verify quality control.
- Followed Good Laboratory Practices (GLP) consistently across daily activities and special products.
Medical Assistant
KU Clinical Research Center
07.2014 - 07.2017
- Responsible for preparing the patients for ambulatory care visit by obtaining vitals, drawing labs – handling and processing blood samples, taking EKG's, performing limited procedures, scheduling diagnostic testing and consults.
- Documented vital signs and health history for patients in clinic and hospital environments.
- Scheduled appointments, registered patients, and distributed sample pharmaceuticals as prescribed.
- Directed patients to exam rooms, fielded questions, and prepared for physician examinations.
- Sanitized, restocked, and organized exam rooms and medical equipment.
- Collected and documented patient medical information such as blood pressure and weight.
- Obtained client medical history, medication information, symptoms, and allergies.
- Kept medical supplies in sufficient stock by monitoring levels and submitting replenishment orders before depleted.
- Assisted clinical research staff with specimen collections and study specific tasks.
Medical Assistant
Lady of the Lake/Franciscan Clinic
06.2012 - 07.2014
- Lab testing included EKGs, spirometer, nebulizer treatments, urine dipstick, rapid strep, flu screenings, plating and assessing throat cultures.
- Assisting Physician with gynecological specimen collection and procedures.
- Completed required laboratory quality control measures.
- Obtained client medical history, medication information, symptoms, and allergies.
- Completed immunizations, confirm no contraindications, draw up vaccine at provider's direction and administer oral/sub-q/intramuscular medications.
- Assisted the physician and nurse practitioner with triaging patient calls.
Medical Assistant
Ochsner Medical Center/Oncology
08.2011 - 06.2012
- Documented vital signs and health history for patients in clinic and hospital environments.
- Scheduled appointments, registered patients, and distributed sample pharmaceuticals as prescribed.
- Assisted with routine checks and diagnostic testing by collecting and processing specimens.
- Directed patients to exam rooms, fielded questions, and prepared for physician examinations.
- Provide back up coverage for other staff members.
- Assisted physicians with minor surgeries, including preparing the operating room and sterilizing instruments.
Medical Office Coordinator
Broadmoore High School Health Center
01.2009 - 01.2011
- Coordinated adolescent patient clinical visits.
- Administered and arranged for medications at physician direction.
- Administered vaccinations at physician direction.
- Assured that referrals, prior authorizations, and pre-certifications are in appropriate database system accurately and in a timely manner.
- Assisted with routine checks and diagnostic testing by collecting and processing specimens.
- Managed monthly billing process to complete billings and returns to meet company revenue recognition policies.
- Established and maintained effective communication with staff, physicians and community organizations to promote high quality patient care.
Assistant Client Services Director
American Health
01.2007 - 01.2009
- Geriatric patient care management.
- Monitored vital signs, developed and implemented care plans, and documented patient progress.
- Coordinated with other healthcare team members to support patient needs.
- Trained, guided, supported and supervised home health aide care providers.
- Assisted with end-of-life care.
Education
Certifications
12.
MA -
MTC
Louisiana2007
AS -
BRCC
Baton Rouge, LA2005
Skills
- Proficient knowledge of FDA regulations and GCP-ICH guidelines
- Strong leadership skills with the ability to collaborate, motivate individuals, and ensure accountability
- Understanding of business needs and objectives across functional areas
- Proficiency in medical terminology and adherence to guidelines regarding transparent and honest reporting of confidential and sensitive patient information
- Recognition of the impact of data integrity on patients, study results, costs, quality of service, and scientific research in general
- Excellent written and verbal communication skills with superb attention to detail
- Ability to multi-task and manage multiple competing priorities
- Ability to work independently and collaboratively
- Proficiency in PC operations and software applications, such as MS Outlook, Windows, Excel, and Word
Timeline
Senior Clinical Data Coordinator
KU Cancer Center
12.2021 - Current
Senior Laboratory Coordinator
KU Cancer Center
08.2017 - 12.2021
Medical Assistant
KU Clinical Research Center
07.2014 - 07.2017
Medical Assistant
Lady of the Lake/Franciscan Clinic
06.2012 - 07.2014
Medical Assistant
Ochsner Medical Center/Oncology
08.2011 - 06.2012
Medical Office Coordinator
Broadmoore High School Health Center
01.2009 - 01.2011
Assistant Client Services Director
American Health
01.2007 - 01.2009
Certifications
MA -
MTC
AS -
BRCC
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