Clinical Research Coordinator coordinating complex clinical research studies for Washington University in St. Louis. Collaborating with investigators and managing all phases of research protocols in a regulatory environment.
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Onsite Clinical Research Professional II, Radiology
Posted 2 days ago
About the role
- Provide direction, instruction and guidance to coordinate research activities, including patient screening and recruitment, enrollment and education.
- Ensure protocol procedures have been completed adhering to Good Clinical Practice Guidelines as defined by the Federal Drug Administration (FDA) and serve as subject matter expert.
- Coordinate nursing/social work and patient care and/or patient follow-up functions of the clinical study, including planning and developing related activities.
- Provide quality patient care to patients and their families within area of clinical specialty.
- Collaborate with care coordinators, social workers, psychologists, physicians and other appropriate treatment team members in diagnostic formulation, treatment direction, and recommendations.
- Act as a liaison with medical staff, university departments, ancillary departments and/or satellite facilities.
- Assist with developing and revising policies and procedures for the research team to ensure compliance with the protocol.
- Serve as a resource within the department for the development of less experienced team members.
- Contribute to the development of new processes, procedures, tools and training to enhance clinical research activities, compliance, and efficiency.
- Ensure compliance with contract principles, federal regulations, laws and University of Cincinnati/University of Cincinnati Physicians Company (UCPC) policy and operating procedures.
- Work closely with UC and UC Health offices in negotiation of contracts, confidentiality agreements and amendments related to the conduct of research activities.
- Work with necessary parties to identify compliance, legal, IP and business/financial risk.
- Mitigate risk through working with physicians/faculty, divisions, legal and/or other departments.
- Review industry and sponsored research clinical trial budgets for consistency with UC/UCPC policies and operating procedures.
- Prepare, submit, and assist Director with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
- Prepare and maintain FDA applications for Investigational New Drugs (INDs).
- Maintain regulatory documentation.
- Conduct internal audits.
- Make and assist in modifying protocols and study documents.
- Write reports, business correspondence, and procedure manuals.
- Create data entry instructions and train data entry specialists.
- Assist with creation of case report forms.
- Create, test, and perform basic maintenance for databases.
- Act as liaison between study personnel and data entry specialists.
- Perform quality checks on data entered by others.
- May serve as a resource person or act as a consultant within area of clinical and/or regulatory expertise.
- Assist with preparing, developing, reviewing and negotiating industry and sponsored research clinical trial budgets for consistency with UC/UCPC policies and operating procedures.
- Perform related duties based on departmental need.
Requirements
- Bachelors Degree.
- Seven (7) years of relevant education, experience and/or other specialized training can fulfill minimum education and experience requirements.
- Three (3) years relevant experience.
- Experience in an academic or clinical setting in the area of clinical specialization.
Benefits
- Comprehensive Tuition Remission
- Robust Retirement Plans
- Real Work-Life Balance
- Competitive salary based on experience
- Comprehensive health coverage (medical, dental, vision, prescription)
- Flexible spending accounts & wellness programs
- Professional development & mentorship opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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