Site Start-Up Specialist
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The Opportunity
Description
- 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.
- Performs all the roles encompassed in the preceding grade levels within the job family as required by the organization. Conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all company policies and procedures.
- Directly manages clinical site initiation activities.
- Reviews approval of clinical study informed consent forms and patient privacy authorization forms.
- Ensures all required documentation and training has been properly executed, received in-house and filed appropriately. Completes all required debarment and medical license checks.
- Assures all requirements are met for IP release.
Our Client
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
- Bachelors in life sciences or related field
- Atleast 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, Microsoft Outlook
- Experience with Adobe Acrobat Professional and Microsoft Access a plus
- 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
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?
