Tonya Higgins Email and Phone Number
Tonya Higgins work email
- Valid
- Valid
- Valid
- Valid
Tonya Higgins personal email
Tonya Higgins phone numbers
Self-motivated Clinical Research professional with 19 years of expertise in managing clinical research trials within the CRO industry.Core Competencies | Technology:Risk base monitoring | Regulatory | ICH/GCP, Vendor/Site/Data Management | Recruitment | Query Resolution | IP Reconciliation/Accountability | AE/SAE Reporting | RAVE | Medidate | CTMS | eTMF | CAPA | ISF | SOPs | Audits | Budgets | OneNote | Microsoft Office.Enjoy traveling 2-3 days on-site, working with site staff and collaborating with diverse teams to ensure patient safety.Management | Organization:Performs onsite, remote, co-monitoring and risk based monitoring activities: PSVs//SIVs presentations for site Qualifications | Training | User Access | Facility Equipment | Activation | IMVs ensure protocol compliance, patient safety and data integrity | COVs preparation for database lock.Communication:Fluent English: Protocol | Regulatory Document Review | Site Communication, Guidance and Support | Visit Report timely Submission.Problem Solving: Passionate about process improvement, team collaboration, and career balance. Eager to learn, adapt, agile and contributor to the advancement of clinical research.
Syneos Health
View- Website:
- syneoshealth.com
- Employees:
- 23167
-
Syneos HealthUnited States
-
Clinical Research Associate Ll Dedicated To Bristol Myers SquibbSyneos Health Mar 2023 - PresentMorrisville, Nc, Us
-
Clinical Research Associate L Dedicated To SanofiIcon Plc Jan 2022 - Mar 2023Dublin, Ie -
Clinical Research Associate FspIqvia Jul 2021 - Dec 2021Durham, North Carolina, Us -
Clinical Data LeadIcon Plc Oct 2020 - Jun 2021Dublin, IeServe as Lead Data Management point of contact for day to day activity on study, overseeing and coordinating tasks delegated to the study team members both locally and in other offices: • Leads the development of specifications, implementation, testing of eCRF or paper edit checks and data review, overview listings utilizing Microsoft Excel Architectural Loader Specification Rave Specification Builder as communication tool.• Leads development of the Data Management Plan Data Reporting Plan Study Specific Procedures including control of distribution and team training.• Ensure standard metrics and status reporting are set up and maintained on study. Set up and maintain DM files ensuring they are audit ready.• Continue professional development attend participate in DM Academy courses.• Review current SOPs work-instructions guidelines to ensure compliance.• Contribute to internal/sponsor teleconference meetings provide timeline updates planning and expectations. Listen respectfully.
-
Clinical Data CoordinatorThe University Of Kansas Cancer Center Oct 2019 - Oct 2020Kansas City, Ks, UsServe as lead support for study start up to database closure activities related to data collection reporting monitoring of assigned Oncology Early Phase clinical research trials:• Practice current Industry regulations governance electronic records signatures e.g. ICH/GCP E6 (2) 21CFR11.• Review timely resolve monitoring prior visit follow up letter action items.• Research investigate data issues and follow-up to timely resolution.• Comprehend follow escalation pathway.• Consult with primary investigator regulatory site staff on protocol deviations and follow guidance for criteria reporting into safety database.• Report track reconcile SAEs reports inclusive hospital summary diagnosis medications procedures ensure patient confidentiality by redacting subjects identifiers prior to sending to sponsor.• Review interpret Pathology reports for data collection consult with the investigator for end results oversight.• Extract medical reports from EMR for eligible study participants e.g. radiology reports, prior regimens histological Staging data.• Participate in sponsor kick off meetings. -
Clinical Project CoordinatorIqvia Dec 2013 - Aug 2018Durham, North Carolina, UsProvide administrative support to the data management project team to facilitate the processing and cleaning of clinical trial data:• Perform User Acceptance Testing Data validation specification utilizing Microsoft Excel. Submit track controlled role access documentation.• Consult with primary investigator to resolve medical coding issues lab testing oversight.• Manage clinical trial documentation such as case report forms within data management including, distributing data clarification forms tracking filing of data management project documentation.• Interact with clinical data management staff management and other project team members to resolve issues and provide status information.• Create study specific documents ensue signature process prior to filing Investigational Site File.• Assist Data Operations in the creation and maintenance of Data Management Study Files and Data Management Plan, etc.• Coordinate project related meetings including client visits.• Generate regular status reports Archive project documentation.• Record monitor study progress trends patient treatment activities timely prepare study reports.
-
Associate Clinical Data CoordinatorIqvia Dec 2009 - Dec 2013Durham, North Carolina, UsEntry of clinical data and document administration into Clinical Data Management Systems to produce efficient quality data management products that meet customer needs:• Perform data entry filing scanning indexing of trial data.• Manage 4-6 protocols simultaneously maintain quality and integrity throughout the study.• Prepare and present study materials CRA training for site initiation visit e.g. System training Data quality Study specific case report training utilizing Microsoft PowerPoint.• Ensure case report forms are processed logged tracked in accordance with processing instructions.• Manage vendor data batch transfers ensure complete accurate subject identifiers setup in accordance with protocol.• Ensure Quality control checks are complete it according to work instructions and guidelines.• Assist with documentation and resolution of data issues.• Assist with the production and/or review of Data Tracking/ Data Entry Guidelines. • Mentor and train Data Associates.• Develop maintain good communications within cross functional team members.
-
Clinical Data CoordinatorIqvia Dec 2007 - Dec 2009Durham, North Carolina, UsPerform data entry quality control verification of study data for study specific casebooks:• Review scope of work included in contract protocol and other study related documentation ensure adherence to such protocol.• Participate in the planning designing writing and implementation of new processes procedures and flowcharts.• Coordinator with study director and customer regarding specific study requirements for data collection and reporting.• Review original source documentation clarify ambiguous data and transcribe data to study specific casebooks (may be paper or electronic data entry) according to customer approved timelines.• Create study specific source documents e.g. adverse event concomitant medication PE MH study tracker Data entry Guidelines using Microsoft.• Perform quality checks per guidelines prior to sponsor visits.• Recruit and educate participant for potential trial inclusion. Follow HIPPA requirements ensure subjects rights obtain signed consent form.• Modify casebook per sponsor request. • Obtain appropriate signatures in casebooks.• Participate in a variety of team quality improvement efforts as necessary.• Independently identify areas of needed improvement.• Perform other duties as required.
-
Clinical Data AssociateIqvia Jan 2006 - Dec 2007Durham, North Carolina, UsProvide administrative support for Data Management Clinical Operations team to manage Clinical Trials: • Collect review demographic medical history diagnosis treatments medication laboratory tests hospital records to ensure participant qualification.
Tonya Higgins Skills
Tonya Higgins Education Details
-
Baker UniversityBusiness Management -
The Cra Academy, DscsClinical Research Associate
Frequently Asked Questions about Tonya Higgins
What company does Tonya Higgins work for?
Tonya Higgins works for Syneos Health
What is Tonya Higgins's role at the current company?
Tonya Higgins's current role is Clinical Research Associate ||.
What is Tonya Higgins's email address?
Tonya Higgins's email address is to****@****plc.com
What is Tonya Higgins's direct phone number?
Tonya Higgins's direct phone number is +191389*****
What schools did Tonya Higgins attend?
Tonya Higgins attended Baker University, The Cra Academy, Dscs.
What skills is Tonya Higgins known for?
Tonya Higgins has skills like Clinical Data Management, Clinical Research, Documentation, Clinical Trials, Cro, Data Management, Ctms, Management, Pharmaceutical Industry, Gcp, Edc, Healthcare.
Who are Tonya Higgins's colleagues?
Tonya Higgins's colleagues are Ana Laura Carol Flores, Vivi Xatzidimitriou, Morgan Froelich, Charitha Reddy, Laurin Khan, Niyi Fila, Larissa Schmidt.
Free Chrome Extension
Find emails, phones & company data instantly
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial