Clinical Research Program Specialist II

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Position Summary:

The Clinical Research Program Specialist II is responsible for providing regulatory administrative support to the Clinical Research Operations group for Caris sponsored research studies.

Job Responsibilities:

• Maintain intake of assigned research project IRB approvals and expiration documents.
• Monitor local site IRB and WIRB activities, including additional site submissions, amendments/changes in research submissions, create/facilitate submission of annual continuing review reports, monitor and notify of document expiration dates, and process fees through accounts payable.
• Liaison between Caris and physician investigator(s), research institute(s), contract research organization(s), regulatory agencies and other designated stakeholders.
• Tracking and oversight of all assigned studies through onboarding and regulatory startup; reporting progress against any applicable milestones.
• Assists with the creation of new study/site database entries, including site information and required documents.
• Develops and maintains all regulatory, legal and financial disclosure documents per guidelines and regulations of the sponsor and IRB.
• Supports quality improvement initiatives and implementation of policies and procedures associated with Caris research and regulatory requirements.
• Review, revise, author and implement new procedures to achieve regulatory compliance and operational efficiency.
• Provide support during internal or external inspections.
• Supports various projects/tasks as assigned.

Requirements

• Knowledge, Skills, and Experience
• Ability to multi-task and work in a fast-past, deadline driven environment.
• Enthusiasm and dedication to meeting group objectives.
• Consistently exhibits a professional demeanor in the workplace and works to maintain positive relationships.
• Ability to work under routine and stressful situations in an accurate and timely manner.
• Effective verbal and written communication skills.
• Attention to detail and excellent organizational skills.
• Effective interpersonal and team skills.
• Proficient in Microsoft Office Suite, specifically Word, Excel, PowerPoint and Outlook.
• Results oriented; hyper focused on service, quality, and continuous improvement
• Teamwork player; commitment to the overall success/achievement of team and organizational goals.

Education, Certification/Licensure, and/or Experience

• B.S. degree in a scientific discipline (or equivalent work experience).
• Research professional with 1-2 years regulatory experience.
• Experience working in a regulated environment (CLIA, NYS, CAP, FDA, ISO, etc.).

Physical Demands

• Employee may be required to lift routine office supplies and use standard office equipment.
• Ability to sit for extended periods of time.
• Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes and bio-hazardous material in the lab environment.

Other

• This position requires some evenings, weekends and/or Holidays.

This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Caris Life Sciences is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability or genetic information, or any other protected characteristic as outlined by federal, state, or local laws.

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