Alison Combs Email & Phone Number

Kci

A Start-up Lead (SUL) that drives, manages and leads all aspects of Clinical Start-up activities at the country/region and project level to achievesuccessful activations of sites within timeline and according to budget; ensuring all tasks meet Client and PRA expectations and are delivered inaccordance with the contract, trial protocol, ICH-GCP, applicable local regulations and requirements, and SOPs; and proactively identifies,resolves/mitigates and escalates risks and/or issues and may manage multiple countries within the same study and/or multiple studies.

Lenexa, Ks

Performs investigator recruitment activities utilizing phone scripts,questionnaires, study site materials and other tools for use in evaluatinginvestigative sites.•Utilizes the Clinical Trial Management System (CTMS) to ensure investigatorrecruitment activities are accuratelytracked.•Performs essential document collection, review, maintenance and close-outactivities, ensuring that sponsor and investigator obligations are being met andare in compliance with applicable local regulatory requirements and ICH/GCPguidelines.•Supports investigators and investigative staff in fulfilling obligations with regardto local submissions according to local regulatory and Institution Review Board(IRB)/Independent Ethics Committee (IEC) requirements.•Performs study tracking via CTMS or Sponsor designated system to ensure thatthe study files are current, accurate andcomplete.•Documents site and Sponsor contact and study interactions in a timely andprofessional manner.•• Assists with resolution of investigational site/data queries.• Liaises with project team members regarding study site issues.• Provides quality review of the informed consent template.Performs study duties in adherence to the protocol, Clinical Management Plan(CMP), study processes, ICH-GCP and anyother requirements stipulated on thestudy.•Follows up with sites for trial invoices and ensures CTMS is accurately updatedto allow the timely processing ofInvestigator Payments.•• Performs other duties as assigned.

Lenexa, Ks

Attends on the job and online training sessions that will enrich industryknowledge•Works actively in project team environment by participating in internal andexternal client meetings, as required•Assists team members with the completion of clinical research project-specifictasksUtilizes appropriate tools/PRA systems to produce accurate and efficientdeliverables•Supports mentors and business unit contacts in fulfilling obligations likepreparing and maintaining documentation, plans, reports, schedules, databases,spreadsheets, and logs, as needed•Assesses individual career-path interests while being exposed to various businessunits•• Exhibits good communication and interpersonal skillsCapacity to relay instructions and information and follow commitments throughto completion•• Performs other duties as needed