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Clinical Research Laboratory Coordinator

Company: University of Colorado
Location: Aurora
Posted on: June 21, 2022

Job Description:

University of Colorado - CU Anschutz Medical CampusSchool of Medicine - Division of Hematology - Hematology Clinical Trials UnitOfficial Title: Research Services Entry Clinical Science ProfessionalWorking Title: Clinical Research Laboratory CoordinatorPosition #00796305 - Requisition #25891* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *The University of Colorado has a requirement for COVID-19 vaccinations and full completion thereof by 9/1/21 or upon start date.Information regarding this requirement, and exemptions can be found at:Anschutz: https://www.ucdenver.edu/docs/librariesprovider284/default-document-library/3000-general-admission/3012covid-19-vaccination-requirement-and-compliance.pdf?sfvrsn=4e9df3ba_2Denver: https://www.ucdenver.edu/coronaviruExemptions vary by campus location/department. Campus/Unit-Specific Exemptions: Anschutz Campus - Exemptions are allowed for medical or religious reasons. Denver Campus - Exemptions are allowed for medical, religious, or personal reasons. Consolidated/Central Services Administration - Will follow Anschutz policy on exemptions.The University of Colorado Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty and staff of diverse backgrounds.The University of Colorado Anschutz Medical Campus is a world-class medical destination at the forefront of transformative science, medicine, education and patient care. The campus encompasses the University of Colorado health professional schools, more than 60 centers and institutes, and two nationally ranked independent hospitals - UCHealth University of Colorado Hospital and Children's Hospital Colorado - that treat more than two million adult and pediatric patients each year. Innovative, interconnected and highly collaborative, the University of Colorado Anschutz Medical Campus delivers life-changing treatments, patient care and professional training and conducts world-renowned research fueled by over $650 million in research grants. For more information, visit www.cuanschutz.edu. The School of Medicine's Division of Hematology, Hematology Clinical Trials Unit has an opening for a full-time University Staff (unclassified) Clinical Research Laboratory Coordinator position.Jobs in the Research Services career family provide direct professional support of research activities.Functions include contracts and grants solicitation and administration, grant/agreement preparation, review and negotiation, regulatory compliance, sponsor communication and post and pre award management, human subject compliance, research animal management, research laboratory coordination and instruction, environmental health and safety, radiation control, hazardous materials use, disposal and training.Professionals at the entry level are responsible for exercising discretion, analytical skill, personal accountability and responsibility in a wide range of areas including academic, administrative, managerial and student services functions. Work involves creating, integrating, applying and sharing knowledge directly related to a professional field. At the entry level, duties are limited in scope and are performed with guidance and direction from other professionals and are performed in a training and development capacity.Nature of WorkEntry Clinical Science Professionals perform clinical research related functions which may include patient-oriented research or research conducted with human subjects. Patient-oriented research includes mechanisms of human disease, therapeutic interventions, clinical trials, or development of new technologies. Entry Clinical Science Professionals may also assist with epidemiologic and behavioral studies and/or outcomes research and health services research.This professional will support the Division of Hematology Clinical Trials Unit (HCTU).This position is responsible for specimen collection and processing, data collection and quality assurance monitoring of clinical trials.Investigators in the Division of Hematology's Blood Cancer Program are actively engaged in multiple research activities aimed at improving outcomes for patients with blood cancers and related disorders. These studies are wide-ranging and involve extensive collaboration between laboratory scientists and physicians. Our work is funded by the National Cancer Institute (NCI), the American Cancer Society (ACS), the Leukemia and Lymphoma Society (LLS), and numerous other foundations and industry sources.A key strength of our research group is its highly collaborative and cross-disciplinary nature, which provides an ideal environment in which to develop new therapies. The Hematology Clinical Trials Unit (HCTU) plays an integral role in conducting the clinical research components of the division and has made bringing bench-to-bedside research a huge divisional success. The HCTU is comprised of over 30 employees, and their dedication and investment each day are seen and felt by patients who have and will participate in a clinical trial.Examples of Duties Performed Assist with and oversee the day-to-day operations of clinical trials and studies Assist teams to set up lab kits as neededPerforms clinical duties as assigned based on appropriate licensure and/or completion of competency documentation Maintains daily refrigerator and freezer temperature logs Perform informed consent process or ensures that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required Interview prospective subjects for a variety of research clinical trials. Educate potential subjects on the details of the studies through phone contacts and personal interviews Schedule subject participation in research clinical trial, coordinating availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy) Collect, code, and analyze data obtained from research in an accurate and timely mannerProvides protocol specific specimen collection, processing, storage, and shipping to ensure specimen integrity. This includes processing of specimens (serum, plasma, tissue and urine) according to the requirements of each protocol; centrifugal force, temperature, and individual aliquotsAddresses data queries and discrepancies in a timely manner Adhere to research regulatory standards Assures adherence to all research standards as set forth by the Food and Drug Administration (FDA), the Office for the Protection Against Research Risks (OPPR), the University of Colorado Hospital (UCH), and the CU Cancer Center Maintain detailed records of studies to ensure compliance with requirements of the Food and Drug Administration (FDA), study protocols, department, hospital/clinical standard operating procedures and other regulatory guidelinesDocuments collection and processing times of all specimens in protocol specific source documents and/or pharmacokinetic (PK) logCreates and maintains subject shadow charts, files source documentationAbstracts and records all patient data essential to the study onto required Case Report Forms (CRFs) and into the Clinical Trials database, as needed, in an accurate and timely fashionReports and records all pertinent information, not otherwise specified above, in a timely manner with attention to HIPAA. Ensure that the necessary supplies and equipment for studies are in stock and in working order Ensures necessary maintenance on laboratory equipment (centrifuge, freezer, and refrigerator) Additional Examples of Duties Performed Ensures accurate and timely shipping of specimens Coordinates, schedules and interfaces with Clinical Trial sponsor representatives, study monitors, CRO personnel Conducts follow-up of study patients Attends investigator-coordinator meetings, initial orientations, study audits, and closeout visits as needed. Develop source documents as needed for sample collection when documents not provided by study sponsorThis description is a summary only and is describing the general level of work being performed, it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.Salary and BenefitsThe salary range (or hiring range) for this position has been established at $44,403 to $56,481.The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialty and training.The above salary range (or hiring range) represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.This position is not eligible for overtime compensation.Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.Benefits: https://www.cu.edu/employee-services/benefitTotal Compensation Calculator: http://www.cu.edu/node/153125Diversity and EquityThe University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@ucdenver.edu. The University of Colorado Denver - Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities and all veterans. The University of Colorado is committed to diversity and equality in education and employment.The University of Colorado Denver - Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.QualificationsMinimum Qualifications Bachelor's degree in any field A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis Required: Applicants must meet minimum qualifications at the time of hire.Preferred Qualifications Bachelor's degree in science or health related field Clinical research or related experience Experience with specimen collection, data collection and quality assurance monitoring.Competencies, Knowledge, Skills, and Abilities Knowledge and understanding of federal regulations and Good Clinical Practice (GCP) Ability to communicate effectively, both in writing and orally Ability to establish and maintain effective working relationships with employees at all levels throughout the institution Outstanding customer service skills Demonstrated commitment and leadership ability to advance diversity and inclusion Knowledge of basic human anatomy, physiology medical terminology Ability to interpret and master complex research protocol information

Keywords: University of Colorado, Aurora , Clinical Research Laboratory Coordinator, Healthcare , Aurora, Colorado

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