Senior Clinical Trial Specialist
Current
Jul 2021 - Present
Who is Ally K.? Overview
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Quick answer
Ally K. is listed as Senior Clinical Trial Specialist at Treximo, based in Mountain City, Tennessee, United States. AeroLeads shows a matched LinkedIn profile for Ally K..
Ally K. previously worked as Senior Clinical Records Specialist at Execupharm and Clinical Trial Specialist at Advanced Clinical. Ally K. holds Bachelor'S Degree, Healthcare Administration from Aspen University.
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Treximo
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Profile bio
About Ally K.
Over seven years in the industry from Study Start Up Specialist to Clinical Trial Specialist to Clinical Documentation Specialist. Experience with Phases 1-4, and multiple therapeutics. I am very passionate about healthcare and being part of a team that works together to create cures and treatments. I am a dependable and hard working teamplayer.
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6 roles
Ally K. work experience
A career timeline built from the work history available for this profile.
Senior Clinical Records Specialist
Maintenance of Trial Master File*Manage the controlled access process, including access training and monitoring*Manage study file structure process and documentation*Manage record archival and retrieval processes*Perform training cross-functionally to set expectations for filing in the TMFSupport internal and regulatory audits and inspections by making TMF.
Dec 2020 - Jul 2021
Clinical Trial Specialist
Clinical Trial Specialist- FSP Associate for Advanced ClinicalOrganize /track study files related to SSU or other aspects of the trial as required in collaboration with the Document SpecialistGrant access to InForm through UMT for usersSuvoda, iCORE, Veeva Vault, Clinical One, MasterControlResponsible for coordinating the day to day work flow of collection.
Sep 2019 - Nov 2020
Clinical Document Specialist
- Clinical Document Specialist, FSP Associate for Advanced Clinical
- Assist with site feasibility including preparation, distribution, collation of responses, and documentation of the decisions related to site selection
- Forecast anticipated submission/approval timelines and works with investigational sites and study teams to ensure adherence
- Independent preparation, review, collection, and approval of site level critical documents required for study start up (greenlight for site initiation/release of investigational product) within agreed timelines and in.
- Review of informed consent forms used by the investigational sites including negotiating language between central institutional review boards (IRBs) and ethics committees with support from study team and legal.
- Serve as direct contact with investigational sites to assist with review and collection of site start up documents
Oct 2018 - Sep 2019
Start Up Associate Specialist I, Start Up Operations North America /Clinical Development
- Promoted to Study Start Up Specialist I after 2 years of proving my diligent efforts, team and independent work, training colleagues on processes and systems, proven track of site start up while meeting metrics and.
- Collected, reviewed, processed, and tracked regulatory and investigative documents for study site activation in accordance with Covance SOPs, sponsor SOPs, ICH GCP guidelines, EU Clinical Trial Directive, FDA.
- Negotiated contracts and budgets between Sponsor and Sites
- Assisted in review of core English, Country, and investigative site specific patient informed consents for compliance to respective international or country requirements and protocol as applicable
- Maintained and updated document tracking information in the Trial Tracker Site Information Module and other tracking logs
- Assessed impact of site personnel changes on regulatory documents and process/review new documents according to ICH/GCP guidelines
Jun 2018 - Oct 2018
Study Start Up Specialist
- Collected, reviewed, processed, and tracked regulatory and investigative documents for study site activation in accordance with Covance SOPs, sponsor SOPs, ICH GCP guidelines, EU Clinical Trial Directive, FDA.
- Negotiated contracts and budgets between Sponsor and Sites
- Assisted in review of core English, Country, and investigative site specific patient informed consents for compliance to respective international or country requirements and protocol as applicable
- Maintained and updated document tracking information in the Trial Tracker Site Information Module and other tracking logs
- Assessed impact of site personnel changes on regulatory documents and process/review new documents according to ICH/GCP guidelines
- Liaised with applicable IRB/IEC regarding investigator submission/approval issues as appropriate
May 2016 - Jun 2018
7 education records
Ally K. education
Bachelor'S Degree, Healthcare Administration
Aspen University
Associate Of Science (A.S.), Radiology
Career Technical College-Monroe
Education record
Inform 6.1 Sponsor View Only Certificate
Education record
International Council On Harmonization (Ich) E6 Good Clinical Practice (Gcp) Guideline
Education record
Oracle Health Sciences- Clinical One/Hs Learn
Education record
Umt 12.0.X User Management Tasks In Infor
Associate'S Degree, Medical Assisting
Career Technical College
FAQ
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Quick answers generated from the profile data available on this page.
What company does Ally K. work for?
Ally K. works for Treximo.
What is Ally K.'s role at Treximo?
Ally K. is listed as Senior Clinical Trial Specialist at Treximo.
Where is Ally K. based?
Ally K. is based in Mountain City, Tennessee, United States while working with Treximo.
What companies has Ally K. worked for?
Ally K. has worked for Treximo, Execupharm, Advanced Clinical, and Covance.
How can I contact Ally K.?
You can use AeroLeads to view verified contact signals for Ally K. at Treximo, including work email, phone, and LinkedIn data when available.
What schools did Ally K. attend?
Ally K. holds Bachelor'S Degree, Healthcare Administration from Aspen University.
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