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.

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.
• 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.

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