U

University of Chicago

Private research university in Chicago, IL

Clinical Research Coordinator 2

Clinical Research OperationsPosted on Nov 9
Full-timeChicago, IL, USA$60k - $75k

About the Job

Requirements

  • A college or university degree in a related field is required.
  • Two to five years of work experience in a related job discipline is required.
  • Proficiency in Microsoft Office applications, including Outlook, Word, and Excel, and the ability to learn and use clinical research databases and electronic systems.
  • Ability to interpret and apply clinical research protocols, regulatory requirements, and study documentation while identifying and resolving issues.
  • Ability to manage multiple clinical research activities, prioritize competing demands, and meet deadlines.
  • Ability to maintain accurate and complete research records and documentation.
  • Ability to follow clinical research regulations, institutional policies, study protocols, confidentiality requirements, safety protocols, and infection-prevention procedures.
  • Ability to navigate assigned University of Chicago locations and work in clinical research, patient care, and office environments, including potential exposure to biological specimens and other clinical research materials.
  • Ability to accommodate clinical research activities, patient visits, and study requirements through schedule flexibility as needed.

Responsibilities

  • Manage clinical trial activities, including screening, enrollment, subject follow-up, case report form completion, and adverse event reporting.
  • Recruit and interview potential study patients with guidance from the principal investigator and clinical research staff.
  • Collect, process, ship, and store specimens at the appropriate laboratory according to established aseptic techniques.
  • Identify and explain the responsibilities of principal investigators, research team members, sponsors, contract research organizations, and regulatory authorities in clinical trials.
  • Coordinate studies from startup through closeout, including subject recruitment and screening, informed consent, research data collection, and protocol adherence.
  • Plan and coordinate patient schedules for study procedures, return visits, and study treatment schedules.
  • Educate patients about study procedures, visit schedules, what to report between and during visits, and procedure risks and benefits.
  • Perform assessments during visits and monitor for adverse events.
  • Organize and attend sponsor site visits and other relevant study meetings.
  • Protect patient and data confidentiality by securing research data and personal health information and complying with federal regulations and sponsor protocols.
  • Implement and document standard operating procedures according to sponsor, principal investigator, and regulatory agency specifications.
  • Maintain accurate and complete records, including signed informed consent, institutional review board approvals, source documentation, case report forms, drug dispensing logs, and study-related communications.
  • Apply knowledge of the institutional review board submission and review process, including independently preparing timely and thorough submissions to facilitate study initiation.
  • Ensure compliance with federal regulations and institutional policies.
  • Prepare and maintain protocol submissions and revisions as needed.
  • Assist in training new or backup coordinators as needed.
  • Assist with professional, organizational, and operational tasks under moderate supervision.
  • Facilitate and participate in daily activities of moderately complex clinical studies, including patient data retrieval, clinical research record documentation, and program audits.
  • Coordinate collection of analyzable clinical research data and samples with limited to moderate independence, and contribute to problem-solving on assigned studies and tasks.
  • Perform other related work as needed.

Desired Qualifications

  • Relevant clinical research experience.
  • Working knowledge of coordinating multiple studies, including investigator-initiated, industry-sponsored, and multisite trials.
  • A bachelor's degree in a related field.
  • Ability to communicate clearly and professionally with patients, faculty, staff, research teams, sponsors, and other stakeholders.
  • Ability to establish and maintain effective working relationships with diverse individuals and collaborate across multidisciplinary teams.
  • Ability to adapt to changing research priorities, study requirements, and work assignments while maintaining productivity and quality.
  • Ability to quickly comprehend, retain, and apply new information, including complex study protocols, procedures, and regulatory requirements.

About the Company

University of Chicago

Private research university in Chicago, IL

The University of Chicago is a private research university founded in 1890 in Chicago's Hyde Park neighborhood. It comprises the College, graduate divisions, and professional schools across a broad range of disciplines.

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