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Site Start-Up Specialist
Ref No.: 18-29434
Location: Irvine, California
I. POSITION 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.

II. PRIMARY 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.
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The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan 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

III. ADDITIONAL JOB RESPONSIBILITIES:
Estimated travel may be 10%.

IV. POSITION QUALIFICATIONS:
Education:
Qualified candidates will have a bachelor’s in life sciences or related field

Experience:
At least 2 years experience in clinical research
Prefer candidate with prior experience as Study Start-Up Specialist but not mandatory

Licensure/Credentials:
None

Knowledge, Skills, and Abilities
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