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Maitland

    Study Start-Up Specialist - Maitland, United States - K2 STAFFING LLC

    K2 STAFFING LLC
    K2 STAFFING LLC Maitland, United States

    6 days ago

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    Description

    Job Description

    Job Description

    Description:

    This role will focus on leading all aspects of study start-up activity until the point of site activation. The Study Start-Up Specialist will be responsible for overseeing and planning study start-up processes, collaborating with internal and external stakeholders, ensuring timelines are met with quality execution. The Study Start-Up Specialist acts as a subject matter expert on all start-up related activities and is involved in start-up process improvement.

    Primary Responsibilities:

    • Accountable for study start-up for assigned clinical sites
    • Serve as the primary point of contact for start-up activities, resolving site queries, and assisting sites with all start-up related activities.
    • Collaborate with, but not limited to the following departments: Feasibility, Regulatory, Investigators, Project Management, Ratings, EDC, Laboratory, Pharmacy, Infusion, Finance, Marketing and Recruitment, Source, CTMS, and 3rd party vendors (out-patient procedures).
    • Supports study feasibility in close collaboration with Feasibility Specialist and Site Partnership Specialist as well as the global study team.
    • Collaborate with staff in Operational Strategy & Planning, Business Development and Operations to provide feasibility data and other relevant data.
    • Communicates effectively with project team members to ensure alignment of study start-up strategy and risk mitigation. Selects appropriate communication platforms to convey information effectively and efficiently. May present at intra-/inter-departmental meetings.
    • Ensures that clinical delivery project team members and any other cross-functional team members needed to support site activations understand responsibilities and performance standards.
    • Collect, review, track and complete start-up related documents like Site Contact and Site Information forms, in accordance with sponsor processes and timelines.
    • Assist in resolving site queries and provide regular updates, escalating issues to the operation specialists.
    • Attend weekly start-up meetings with key stakeholders.
    • Maintain start-up tracker with timely updates.
    • Forecast and track metrics and progress of study start-up, ensuring all sites are greenlit on time.
    • Interface with Client representatives and internal departments to ensure timely initiation and completion of clinical trials.
    • Identify potential bottlenecks and develop contingency plans to keep projects on schedule.
    • Coordinate client meetings, schedule internal meetings, and conduct daily communication via telephone and email.
    • Discuss draft ICFs re all required elements prior to IRB submission.
    • Educate Project Specialists and department specialists on relevant study and protocol related information.
    • Provide logistical support to clinical trial supply coordination.
    • Collaborate and share information with other sites in the network who will be working on the same study as distinct sites or satellite sites.
    • Coordinate scheduling of Pre Site Selection Visits (PSVs), Site Initiation Visits (SIVs) and Kick-Off Meetings (KOMs). Ensuring relevant staff are aware and invited.
    • Ensure appropriate staff are registered for Investigator Meetings (IMs). Attend IMs if needed on occasion.
    • Ensure accuracy and timeliness, keep track and enter study timelines and dates in systems as needed (CTMS, Devana LYNK, SharePoint).
    • Mentor junior Study Start-Up Team members.
    • Ensure physicians at research sites are prepared to begin studies and have all the tools they need to do so.
    • Develop and update relevant training documentation, and conduct training where necessary.
    • Ensure all activities within competence are carried out in line with the international ethics and quality standards, current regulations, applicable guidelines and SOPs (Standard Operating Procedures).

    Knowledge, Skills, Abilities:

    • Thorough knowledge of clinical study start-up processes and requirements.
    • Experience with investigator start-up documents and investigative sites.
    • Experience in working with cross-functional teams.
    • Understanding of clinical research processes, site logistics, and study start-up.
    • Strong digital literacy, ability to analyze data, and multitasking skills.
    • Proficiency with Microsoft Office Products – Word, Excel, PowerPoint, SharePoint, PowerPoint.
    • Effective organizational and time management skills.
    • Ability to multitask under limited direction and on own initiative.
    • Strong communication and interpersonal skills.
    • Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues
    • Highly responsive, proactive, and a team player.

    Qualifications:

    • University/College degree or certification in a related allied health profession.
    • Minimum of 1 year of relevant clinical trial experience with a clinical research site or CRO.
    • Familiarity with ICH/GCP requirements and FDA guidelines.
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