Clinical Operations

  • location: Irvine, CA
  • type: Contract
  • salary: $37.10 - $43.65 per hour
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job description

Clinical Operations

Site Start-Up Specialist

Job Summary

The Site Start-Up Specialist is responsible for executing study start-up for assigned protocols with the goal of meeting study start-up timelines.Ensure the accuracy and quality of deliverables from clinical team and vendors. Maintain project metrics and provide status updates to senior management.

Job Responsibilities

Study Start Up Management Associate provides support and/or leadership to their assigned Site Start Up Teams in the execution of all Site Start Up activities and timely initiation of sites for clinical trials.

The Study Start Up Management Associate is expected to be fully capable of performing all the roles encompassed in the preceding grade levels within the job family as required by the organization. Other activities, special projects and assignments may be given as required. As a result, the percentage of time spent across the roles for which the employee is responsible will vary depending on project assignments, current development projects and the requirements within the organization as a whole.

The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all client policies and procedures.

  • Directly manages clinical site initiation activities. Activities include but are not limited to:
  • Review and approval of clinical study informed consent forms and patient privacy authorization forms adapted to IRB-specific formats.
  • Ensuring all required documentation and training has been properly executed, received in-house and filed appropriately.
  • Completing all required debarment and medical license checks.
  • Assuring all requirements are met for IP release.
With proven performance, The Study Start Up Management Associate may act as lead for assigned trials with the mentorship of a more senior Start Up Representative

Education & Qualifications

  • Qualified candidates will have a bachelor's in life sciences or related field
  • At least 2 year's experience in clinical research
  • Prefer candidate with prior experience as Study Start-Up Specialist
  • Knowledge of FDA regulations required.
  • Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, 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
  • Estimated travel may be 10%.
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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