Clinical Research Coordinator
Hyde Park Campus
20123 Ob & Gynecology
About the Unit
The Department of Obstetrics and Gynecology has 98 clinical providers: 42 faculty members, ten clinical fellows, 28 residents, ten physician assistants, six midwives, and two advanced practice nurses providing care at the main hospital in Hyde Park and seven off site locations. We have more than 45,000 outpatient visits, 20,000 ultrasound encounters, 2,500 deliveries, and perform over 2,500 gynecologic surgeries per year. Our physicians see patients at several offsite locations that are managed by the Department and operate at a number of hospitals, including Munster Community hospital in Northwestern Indiana and Northwest Community Hospital in Arlington Heights. The Department of Obstetrics and Gynecology is organized into seven clinical sections: Uro-gynecology, Gynecologic Oncology, REI, Family Planning, Maternal Fetal Medicine, General Obstetrics & Gynecology, and Minimally Invasive Surgery. Each is led by a section chief who is responsible for carrying out the strategy set for the section. The Department is ranked on the US News and World Report ‘best' list. Teaching and research are high priorities for the Department. The residency and fellowship programs are highly ranked and have a history of training leaders in healthcare. The Department also has a significant research enterprise, engaging in population health studies, as well as research conducted in wet laboratories on tumor biology and the mechanisms of hypertensive diseases in pregnancy. Additionally, the Section of Family Planning has established a unique research center, CI3, which focuses on reproductive policy and innovations in sexual and reproductive health.
The Clinical Research Coordinator 1 will manage all aspects of conducting clinical trials from startup to closeout
- Recruitment and screening of study subjects, obtaining informed consent, enrollment of subject in research study, subject follow-up, collecting and analyzing research data, completion of the case report form (CRF), adverse event reports and ensuring protocol adherence
- Plans and coordinates subjects schedule for study procedures, return visits, and study treatment schedules; educates subjects about study procedures to be performed, what to report between and during visits, and the risks and benefits of the procedures; performs assessments at visits and monitors for adverse events
- Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques
- Independently performs assessments to monitor for and identify adverse events and protocol deviations or violations, and assists PI in reporting to the sponsor and IRB under general direction of department, clinical research manager and/or the Office of Clinical Research
- Reviews the protocol plan to understand and assist with planning for the various costs and resources required such as clinical care expenses, personnel effort, site initiation costs (IRB fees, pharmacy costs, etc.), equipment, and supplies
- Organizes and actively participates in site visits from sponsors and other relevant study meetings
- Maintains a safe research environment and ensures compliance with governmental and University policies, procedures and regulations
- Other duties as assigned
- Controls the acquisition/collection, abstraction, processing, privacy, and quality assurance for all clinical research data required for the protocol
- Provides efficient and complete data collection, processing, analysis and reporting; assures source documentation and data abstraction and entry are being done at the protocol specified time-points; ensures data accuracy and integrity by working closely with internal monitors and/or auditors to promptly resolve any data quality concerns or outstanding queries; and, facilitates the exchange of data across projects and organizations
- Protect patient and data confidentiality by ensuring security of research data and protected health information (PHI) and compliance with federal regulations and sponsor protocols
- Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, PI, and regulatory agency specifications
- Maintains accurate and complete records which may include, but are not limited to, signed informed consent, Institutional Review Board (IRB) communication, source documentation, CRFs, drug dispensing logs, and study related communication
- May prepare and maintain protocol submissions and revisions
- Attention to detail
- Ability to work autonomously
Education, Experience and Certifications:
- Bachelor's Degree required
- Minimum of 1 year of research experience or relevant experience preferred
Technical Knowledge or Skills:
- Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others required
- Ability to communicate with tact and diplomacy required
- Strong organizational skills required
- Strong communication skills (verbal and written) required
- Excellent interpersonal skills required
- Strong data management skills and attention to detail required
- Knowledge of Microsoft Word, Excel and Adobe Acrobat required
- Ability to read and understand complex documents (e.g., clinical trials) required
- Ability to handle competing demands with diplomacy and enthusiasm required
- Ability to absorb large amounts of information quickly required
- Adaptability to changing working situations and work assignments required
- Knowledge of patient evaluation and triage procedures and the ability to monitor clinical research patients from many disciplines preferred
- Knowledge of medical terminology / environment preferred
- Understanding of the IRB submission and review process and when and how to apply for IRB review preferred
- Understanding of the federal research regulations and the ability to identify the federal research organizations' role in regulating human research participation preferred
- Cover Letter
- Reference Contact Info upon request
NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application
Depends on Qualification
Scheduled Weekly Hours
Job is Exempt?
Drug Test Required?
Does this position require incumbent to operate a vehicle on the job?
Health Screen Required?
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