- Manages all aspects of conducting clinical trials and clinical research studies from startup to closeout for one or two clinical trials. Responsibilities include, but are not limited to, 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.
- Collects, processes, ships, and stores 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.
- Controls the acquisition/collection, abstraction, processing, privacy, and quality assurance for all clinical research data required for the protocol. Responsibilities include, but are not limited to, 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.
- Protects 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.
- Analyzes protocols and advise treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics.
- Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
- Performs other related work as needed.
- Bachelor's degree in a related field.
- Knowledge of patient evaluation and triage procedures and the ability to monitor clinical research patients from many disciplines.
- Knowledge of medical terminology.
- Understanding of the IRB submission and review process and when and how to apply for IRB review.
- Understanding of the federal research regulations and the ability to identify the federal research organizations' role in regulating human research participation.
- Interact and communicate with clarity, tact, and courtesy with patients, staff, faculty, students, and others.
- Strong organizational skills.
- Strong communication skills, verbal and written.
- Strong data management skills and attention to detail.
- Read and understand complex documents.
- Handle competing demands.
- Resume/CV (required)
- Cover Letter (required)
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Surgical Consultant, General and Plastic Surgery
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Medicorp Inc Chicago, United Statesseeks a BE/BC Plastic Surgeon to join our comprehensive surgical service in, Ill. · As a valued member of Medical Group, your community-based practice will flourish with the following support and benefits: · Comprehensive surgical service including vascular, general, plastic, c ...
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Atlantic MEDsearch Chicago, United StatesPlastic Surgeon needed to establish new independent private practice in NW Indiana. Receive financial assistance to start-up practice. Replace a departure plastic surgeon & benefit from a loyal referral system (already in place). You'll become an integral member of the oncology s ...
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Gpac Chicago, IL, USA, United StatesJob Description · Are you an experienced and passionate Aesthetic Nurse Practitioner looking to take your career to the next level? Our busy and PRIVATELY OWNED Dermatology/Plastic Surgery clinic is seeking a talented Aesthetic Nurse Practitioner to join our team of skilled profe ...
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Physician Providers Mgmt. Corp. Chicago, IL, United StatesFT or PT Plastic/ Cosmetic Surgery Options in Chicago, IL Area OVERVIEW · Location: Prestigious Chicago area · Full time and part-time position options with NO Hospital call · Cosmetic Surgery only · 75% Liposuction; level 2 AN. General AN also available for Abdominoplasty, c ...
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G PAC Chicago, United States Full time· Are you an experienced and passionate Aesthetic Nurse Practitioner looking to take your career to the next level? Our busy and PRIVATELY OWNED Dermatology/Plastic Surgery clinic is seeking a talented Aesthetic Nurse Practitioner to join our team of skilled professionals · As o ...
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Clinical Research Coordinator 1, Plastic Surgery - Chicago, United States - University of Chicago
Description
DepartmentBSD SUR - Research Services: Investigator Initiated Trials
About the Department
At UChicago Medicine, faculty and staff in the Section of Plastic and Reconstructive Surgery are dedicated to caring for patients suffering: covering the entire spectrum of plastic, reconstructive, and aesthetic surgery from breast reconstruction to craniomaxillofacial and microsurgery.
Many faculty members are credited with pioneering several highly technical approaches in post-oncologic reconstructive surgery for cancer survivors, hand surgery, craniofacial surgery, and much more.
In addition, investigators in plastic and reconstructive surgery conduct rigorous research, particularly in the area of tissue engineering and craniofacial/bone biology.
Their work would have widespread implications for individuals with craniofacial defects, such as those caused by trauma or tumor surgery.
Job SummaryThis position performs routine assignments related to the documentation, analysis, and reporting of research data.
Provides input to support the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the Department of Surgery.
ResponsibilitiesEducation:
Minimum requirements include a college or university degree in related field.
* Work Experience:Minimum requirements include knowledge and skills developed through < 2 years of work experience in a related job discipline.
* Certifications:* Preferred Qualifications
Education:
Technical Skills or Knowledge:
When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.
Research
Role Impact
Individual Contributor
FLSA Status
Exempt
Pay Frequency
Monthly
Scheduled Weekly Hours
40
Benefits Eligible
Yes
Drug Test Required
Yes
Health Screen Required
Yes
Motor Vehicle Record Inquiry Required
No
Posting Statement
The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, national or ethnic origin, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law.
Staff Job seekers in need of a reasonable accommodation to complete the application process should call or submit a request via Applicant Inquiry Form.
We seek a diverse pool of applicants who wish to join an academic community that places the highest value on rigorous inquiry and encourages a diversity of perspectives, experiences, groups of individuals, and ideas to inform and stimulate intellectual challenge, engagement, and exchange.
Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.
The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information.
The Report can be accessed online at:
Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.
Clinical Research Coordinator 1, Plastic Surgery professionals in Chicago
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