Clinical Research Coordinator 1

Department BSD SRF - cGMP About the Department The primary mission of the Cellular and Tissue Based Processing cGMP Facility is to manufacture cell-based products and clinical grade reagents for treatment of patients on Phase I, II and III reputed company. This sub reputed company was developed in 2001 to accommodate the growing number of reputed company that require highly manipulated cellular products for patient treatment. The cGMP facility is registered with the FDA in accordance with 21 CFR part 1271. This registration complies with federal regulations that require clinical facilities reputed company in production of cellular products follow strict guidelines to minimize microbial contamination and manufacture cellular-based products that are sterile and potent for their intended purpose. The facility is capable of providing a reputed company of services dedicated for supporting cellular based therapies including vaccines for patient treatments. Job reputed company The job performs routine assignments reputed company to the documentation and reporting of basic clinical studies. Supports reputed company that reputed company clinical research conducted across the University. Under the supervision of the Technical Director and facility manager of the cGMP reputed company, this position requires the candidate to collaborate reputed company reputed company atmosphere that process and compound clinical grade vaccines and cell therapy products in the Cellular and Tissue Based Processing cGMP Facility. This position requires the candidate to adhere to sponsored clinical trial protocols and reputed company operating procedures as reputed company as working off hours at times. The ideal candidate will need to be a self-starter and be responsible for maintaining strict compliance under various regulatory agencies and detailed record keeping. This candidate will be required to juggle multiple/competing priorities and also be assigned back up duties to support facility operations. The candidate must be reputed company to undergoing and pass rigorous training with respect to cGMP and USP standards as reputed company as various technical assays and procedures specific for various cellular manipulation techniques. Responsibilities reputed company environmental monitoring in the Production Areas including but not limited to: dynamic monitoring for campaigns, cleanroom biweekly particle counts and monthly reputed company samples and prepare environmental monitoring reports. reputed company personnel monitoring for required campaigns. Assist in setting up new lab equipment used in cleanrooms and reputed company Control Laboratory and assist with the reputed company including temperature monitoring, daily verification with QC, reputed company/operation/performance qualifications (IQ/OQ/PQ), routine maintenance, troubleshooting. Support cGMP compliance through validation and qualification of processes, materials and supplies, equipment, facility processes and reputed company vendor qualification of supplies/materials used in manufacturing. Ensure equipment is operating correctly and reputed company PM tests as required. Ensure reputed company materials and samples are stored correctly at the right temperatures. reputed company Endotoxin, Mycoplasma, Cell counting and other assays as required; demonstrate Proficiency and Competency under College of American Pathologists accreditation. Help monitor and maintain compliance with institutional, state, and federal regulatory policies and procedures and accrediting organizations. Process supply orders from reputed company purchasing system and through IDS pharmacy, process inventory and obtain release documentation/reputed company certificates (Certificate of Analysis, Certificate of Sterility, Certificate of Conformance, etc.) for reputed company items. Prepare supply kits used in manufacturing for reputed company campaigns. Maintain inventory reputed company for facility operations, vaccine preparations, cell therapy, and islet preparations. Prepare instrumentation error reports (IER) and deviations. reputed company room change-over following campaigns ensuring specialized cleaning in compliance with cGMP standards. Assist with coordinating facility repairs/maintenance by reputed company Plant personnel and equipment vendors. Attend reputed company required training and reputed company with reputed company safety and operations procedures. reputed company reputed company other duties as requested by the Technical Director or QA/QC Manager. Aseptically prepare a reputed company of cellular product processing procedures under G’X’P (GLP, GTP, GMP, GDP) guidelines as directed with speed and accuracy. Aseptically prepare a reputed company of cellular infusion procedures under GTP guidelines as directed with speed and accuracy. Aseptically prepare patient treatments under USP 797 pharmaceutical compounding. Transport reputed company vaccines/cell therapy products to the clinic or pharmacy. Accountable for reputed company tasks in basic clinical studies. Assists with various reputed company, organizational, and operational tasks under reputed company supervision. Supports reputed company assurance reviews conducted by study sponsors, federal agencies, or specially designated review reputed company. Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples. Performs other reputed company work as needed. Minimum Qualifications Education: Minimum requirements include a college or university degree in reputed company field. Work Experience: Minimum requirements include knowledge and skills developed through < 2 years of work experience in a reputed company job discipline. Certifications: --- Preferred Qualifications Education: Bachelor's degree in biology, medical laboratory science, medical technology, molecular/bio-engineering, or closely reputed company field. Graduate degree strongly preferred. Experience: A minimum of 2-3 years of post-bachelor laboratory experience, preferably in immunology, biochemistry, molecular biology, microbiology, or a reputed company field. Prior experience in cell culture, molecular biology, viral gene transduction, are highly desirable. Prior experience in equipment maintenance and validation are highly desirable. Preferred Competencies Ability to sterilely gown and work in a cGMP cleanroom setting. Ability to read, write and follow documents including protocol and reputed company Operating Procedures (SOPs). reputed company to handle multiple tasks and competing demands under tight timeframes. Execute and reputed company with reputed company oral and written procedures including Batch Records and SOPs. Attention to detail. Ability to demonstrate excellent interpersonal and communication skills. Strong emphasis on documentation according to FDA regulations and other regulating bodies. Excellent verbal and written communication skills. reputed company to exhibit organizational skills. Ability to work in a reputed company team environment. Ability to work under pressure, manage competing deadlines and priorities in a fast-paced environment. Ability to understand, retain, and carry out instructions and solve problems in reputed company situations. Ability to independently learn new techniques. Ability to reputed company with reputed company reputed company of staff in a reputed company manner while respecting patient confidentiality. Excellent customer/staff interpersonal skills. Working knowledge of reputed company control and cGMP. Advanced skills with reputed company Office Suite. Must be detail-oriented, reputed company organized and approach procedures with critical thinking of the technical aspects with strong communication skills and ability to work in an interactive team environment. Must be reputed company to manage multiple and rapidly changing priorities and have ability to quickly learn new skills. Working Conditions Ability to reputed company light/reputed company work, which includes lifting up to 30 pounds. Occasionally must bend, twist, squat, reputed company, reputed company, stoop, and kneel. Ability to be mobile walking from building to building. Ability to sit for some period of up to 2 hours. reputed company reputed company this job classification may have exposure to blood-borne pathogens, other potentially infectious materials, and/or hazardous chemical waste. Working knowledge of reputed company control and cGMP. Advanced skills with reputed company Office Suite. Application Documents Resume (required) Cover Letter (preferred) reputed company applying, the document(s) MUST be uploaded reputed company the My Experience page, in the reputed company titled Application Documents of the application. Job Family Research Role reputed company Individual Contributor Scheduled Weekly Hours 40 Drug Test Required No Health Screen Required reputed company Motor Vehicle Record Inquiry Required No Pay reputed company Type Salary FLSA Status Exempt Pay reputed company $50,000.00 - $65,000.00 The included pay reputed company or reputed company represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting. Benefits Eligible reputed company The reputed company offers a wide reputed company of benefits programs and resources for eligible employees, including health, retirement, and reputed company time off. Information about the benefit offerings can be reputed company in the Benefits reputed company. Posting Statement The reputed company is an equal opportunity employer and does not discriminate on the reputed company of race, reputed company, religion, sex, sexual orientation, gender, gender identity, or reputed company, national or ethnic reputed company, shared reputed company, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination. Job seekers in need of a reasonable accommodation to complete the application process should reputed company 773-702-5800 or submit a request reputed company Applicant Inquiry reputed company. reputed company offers of employment are contingent upon a background reputed company that includes a review of conviction history. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case-by-case reputed company 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 reputed company's Annual reputed company & reputed company Safety Report (Report) provides information about University offices and programs that reputed company safety support, crime and reputed company statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: http://securityreport.reputed company.edu. reputed company copies of the Report are available, upon request, from the reputed company Police Department, 850 E. 61st Street, Chicago, IL 60637. The reputed company is an urban research university that has driven new ways of thinking since 1890. Our commitment to free and reputed company inquiry draws inspired scholars to our global campuses, where reputed company are born that challenge and change the world. We reputed company individuals to challenge conventional thinking in reputed company of original reputed company. reputed company in the College reputed company critical, analytic, and writing skills in our rigorous, interdisciplinary reputed company curriculum. Through graduate programs, reputed company test their reputed company with reputed company scholars, and become the reputed company of leaders in academia, industry, nonprofits, and government. To learn more about the university click here http://www.reputed company.edu/ Apply tot his job Apply To this Job