The University of Chicago Department of Surgery is seeking to independently manage the collection, documentation, analysis of complex clinical studies, and reporting of clinical research data, while also providing input into strategic, administrative, and operational decisions impacting clinical research.
Requirements
- Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline.
- Ability to understand complex protocols to assist with billing and budget discussions.
Responsibilities
- Independently coordinates upcoming and ongoing monitoring assignments while meeting expected timelines for completion of monitoring activities and submission of written monitoring reports.
- Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples.
- Identifies and explains the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
- Conducts site initiation visits with subsites/collaborators.
- Performs assessments at visits and monitors for adverse events.
- Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specification.
- Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.
Other
- Oversees and manages the workload of junior clinical research coordinators.
- Leads start-up activities for investigator initiated trials and provides necessary back-up.
- Conducts office management and supply ordering for IIT team.
- Organizes and attends site visits from sponsors and other relevant study meetings.
- Protects patients and data confidentiality by ensuring security of research data and personal health information.
- Performs various professional, organizational, and operational tasks under limited supervision.
- Acts as a resource on clinical research and related aspects of clinical study for other clinical research staff.
- Accountable for complex problem solving on assigned clinical research studies and professional tasks.
- Facilitates and participates in the daily activities of complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits.
- Ability to train others and provide constructive feedback.
- Excellent oral and written communication skills.
- Strong project management skills, strategic problem solving and attention to detail.
- Strong interpersonal skills.
- Commitment to providing a high level of service.
- Ability to work independently and as part of a team.
- Ability to handle sensitive and confidential situations and information with absolute discretion.
- Ability to work well under pressure.
- Resume (required)
- Cover Letter (required)
- Drug Test Required
- Health Screen Required
