Study Start-Up Specialist
Study Start-Up Specialist
Location: West Cancer Center
Why West Cancer Center?
At West Cancer Center, we are committed to advancing groundbreaking research while providing compassionate care. Our team fosters collaboration and professional growth in an environment where every role makes a difference. Join us in driving innovation in cancer research and treatment.
About the Role
As a Study Start-Up Specialist, you will oversee and coordinate all study start-up activities for new research studies. Working closely with study sponsors and internal teams—including data services, regulatory, and contracts/budgets—you will ensure that study start-up performance metrics are met. This role requires professionalism, confidentiality, and strong organizational skills to manage timelines and maintain compliance with research protocols.
What We're Looking For
Education & Experience:
- Associate’s degree or equivalent from a two-year college or technical school OR
- Two to three years of healthcare research experience/training in lieu of a degree OR
- An equivalent combination of education and experience.
Skills & Abilities:
- Excellent organizational and follow-up skills.
- Strong verbal and written communication skills.
- Solid understanding of GCP (Good Clinical Practice) and FDA regulatory requirements.
- Strong problem-solving skills and ability to prioritize tasks in a fast-paced environment.
- Ability to analyze situations and make timely decisions.
- Proficiency in Microsoft Excel, Adobe Acrobat, MS Word, and email applications.
- Ability to work effectively within a team and across departments.
What You'll Do
- Oversee the implementation and management of research studies throughout the start-up process.
- Facilitate execution of Confidential Disclosure Agreements (CDAs).
- Prepare and distribute study documents for Research Steering Committee (RSC) and Disease Research Group (DRG) meetings.
- Communicate committee decisions and manage sponsor expectations.
- Work with Research Leadership and Principal Investigators to complete sponsor-required feasibility questionnaires.
- Ensure all study start-up documents are received from sponsors and distributed internally.
- Maintain study tracking documents and provide updates in weekly staff meetings.
- Manage sponsor site evaluation and site initiation visits.
- Prepare reports to ensure study start-up timelines and performance metrics are met.
- Maintain compliance with GCP research training requirements and track training documents.
- Oversee study-specific training documentation for site staff and provide materials to sponsors upon request.
- Facilitate Site Initiation Visits and transition studies to the Clinical Research Team.
- Assist with special projects as directed by the Director of Research Nursing.
- Maintain professionalism and confidentiality in all interactions.
- Adhere to Cancer Center safety policies and procedures.
- Attend staff meetings and assist with training and orientation of new employees as assigned.
- Serve as a key liaison between internal departments and external sponsors.
- Perform other duties as assigned.
Physical Requirements & Work Environment
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Typical clinical environment with moderate noise levels.
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Ability to stand, walk, reach, climb, balance, stoop, crouch, sit, and use hands/wrists for extended periods.
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Strong verbal and written communication skills for reports, presentations, and sponsor interactions.
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Ability to lift up to 25 lbs.
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Some travel may be required.
Why You'll Love Working Here
At West Cancer Center, we are dedicated to improving patient outcomes through innovative research. We offer competitive benefits, professional development opportunities, and a mission-driven culture where your contributions truly matter. If you are passionate about research and want to make a difference in the fight against cancer, we encourage you to apply.
Ready to Apply?
Take the next step in your career and join our team today!
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