Previous Job
Previous
Study Site Start-Up with Pharmaceutical
Ref No.: 17-01604
Location: Irvine, California
Position Type:Contract
Start Date / End Date: 12/04/2017 to 06/04/2018
STUDY START-UP WITH PHARMACEUTICAL
IRVINE, CA


Project Description:
The Site Start-Up Specialist is responsible for executing study start-up for assigned protocols with the goal of meeting study start-up timelines. Monitor project plans to meet Site Initiation Readiness at the Investigator Meeting. Ensure the accuracy and quality of deliverables from clinical team and vendors. Maintain project metrics and provide status updates to senior management.

Capable of performing all of the activities and responsibilities with direction of the Site Start-Up Unit Manager, Global Monitoring Operations: Director, Associate Director, or designee as follows:
  • Delivers Business Results:
    • Execute study start-up for assigned protocols within Client timelines by identifying clinical team needs, contracting and managing vendor supported tasks and tracking critical timelines.
    • Monitor project plans and communicates and troubleshoots the leading and lagging indicators to meet Site Initiation Readiness at the Investigator Meeting.
    • Ensure the accuracy and quality of site start-up deliverables by reviewing deliverables in reference to Client standards.
    • Review and report on deliverables of vendors.
    • Maintain the tracking of project metrics in Site Start-Up tracker and provide status updates.
    • Work with internal groups to meet deliverables (i.e. Patient Recruitment, Clinical Development, and Clinical Planning).
  • Enhances Organizational Performance:
    • Manage information sharing (i.e. Site Start-Up tracker, Site Identification Tracking Tools).
    • Develop Standard Operating Procedures and Working Documents to document and communicate unit's processes and procedures.
    • Actively share new ideas for efficient and seamless processes during study team meetings.
    • Aggressively seek input from other departments on process improvement and implements process improvement for Site Start-Up initiatives.
    • Provide agendas, meeting minutes and manages follow up items for all Site Start-Up meetings that are assigned.
    • Follow standard processes for the collection and processing of study site start-up documents and site start-up information.
    • Proactively inform manager of down-turns in leading site start-up indicators
    • Maintain all aspects of Site Start-Up portal documentation by updating trackers and providing frequent study updates.
  • Demonstrates Personal Leadership:
    • Provide oversight and direction to vendors related to site start up tasks by overseeing timely delivery of regulatory documents, reviewing documents for quality, providing feedback on quality of vendor deliverables and providing direction to vendor on task requirements and prioritization.
    • Attend clinical team and operational team meetings and provides updates on the timely execution of inter and intra-departmental milestones.
    • Schedule and lead site start-up meetings with clinical team and vendors to review any issues, items for escalation, regulatory document issues, and IRB status.
    • May mentor junior staff members to improve quality of outcomes and to maintain team morale.
  • Develops Human Capital:
    • Train study team members on current process and study execution modalities.
    • May deliver training to junior staff on site start-up execution and Client policy and procedures.
    • Maintain professional relationships with team members, Client staff and study site staff.
    • Set and meet personal and professional goals and objectives.
  • Estimated travel may be 10%.

Required Skills:
  • Qualified candidates will have a bachelor's in life sciences or related field.
  • At least 2 years' experience in clinical research.
  • Prefer candidate with prior experience as Study Start-Up Specialist but not mandatory.
  • Knowledge of FDA regulations required.
  • Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, and Microsoft Outlook.
  • Experience with Adobe Acrobat Professional and Microsoft Access a plus.
  • Must possess excellent skill/ability in the following:
    • Written and Oral Communication.
    • Presentation Delivery.
    • Planning and Organizing.
    • Decision Making, Judgment, and Problem Solving.
    • People Relationships, Influencing Others, Motivating.
      Employees, Team Building.
    • Initiative and Accountability.
    • Proven ability to interact with different functional groups.
    • Ability to easily adapt to a changing environment.
  • Site Regulatory Documents Collection (FDA Form 1572, Signature Pages, Medical Licenses, etc.).
  • Review of Informed Consent Form(s) in order to obtain IRB approval (interface with Legal, Medical Safety Physician, and Study Team for approval of language changes).


This 6+month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.com

ALPHA'S REQUIREMENT #17-01604
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE