Clinical Research Coordinator

Role Summary:

As a Clinical Research Coordinator, your primary objective is to facilitate and organize the daily activities of clinical studies. You'll ensure the collection, accuracy, and validity of research data, adhering to study protocols and timelines. Your responsibilities encompass complex tasks such as compiling, documenting, and analyzing clinical data from medical records. You'll navigate competing priorities and timelines while adhering to stringent regulations and company policies, including Good Clinical Practice (GCP), International Council for Harmonisation (ICH), and Food and Drug Administration (FDA) guidelines.

Main Responsibilities:

General Administration:

• Adhere to Standard Operating Procedures (SOP), GCP, and regulatory practices.
• Coordinate all aspects of study subject care from pre-screening to completion.
• Develop expertise in clinical research operations and implement quality practices.
• Lead process improvement projects and troubleshoot study protocols.
• Foster positive relationships with stakeholders and support physicians in understanding research initiatives.
• Participate in audits, recruit new research personnel, and provide training on study protocols.
• Manage study start-up documents and assist with staffing and scheduling for research projects.
• Engage in continuous training and development to enhance professional skills.

Conduct of Research:

• Act as a liaison between the Principal Investigator (PI) and study sponsor, adapting protocols to local requirements.
• Arrange and lead study-specific coordinator calls.
• Collect and submit regulatory documentation as required by regulatory agencies.
• Develop training tools for patient care staff and resolve conflicting treatment protocols.
• Assist in determining eligible candidates for study participation and ensure enrollment goals are met.
• Educate study subjects on their obligations and rights and maintain accurate study documentation.

Financial Management:

• Review financial statements and ensure adherence to study budgets.
• Coordinate site study subject stipend disbursement and billing charge submissions.
• Provide relevant financial information for study contract negotiations.

Additional Details:

• Location: Newark, DE
• Hours: Monday-Friday; Normal Business Hours; Onsite 5 Days a Week
• Employment: 6 Month Contract to Hire (~1,040 Hours) - Contracted probationary period into direct hire/permanent position
• Pay: $41,600 - $68,600 (Dependent on Background and years of experience)
• Requirements: Must have 1+ years of Clinical Research Experience

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