Clinical Research Coordinator- Center for Lungs and Breathing (Open Rank: Entry-Senior Level)
- Employer
- University of Colorado Anschutz Medical Campus
- Location
- Denver, CO
View more
- Administrative Jobs
- Academic Affairs, Research Staff & Technicians
- Employment Type
- Full Time
- Institution Type
- Four-Year Institution
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Description
University of Colorado | CU Anschutz Medical CampusDivision of Pulmonary Sciences and Critical Care MedicineOfficial Title: Research Services Clinical Science Professional (Open Rank)Working Title: Clinical Research Coordinator- Center for Lungs and Breathing (Open Rank: Entry-Senior Level)Position #00793004 – Requisition #24393* 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/3012---covid-19-vaccination-requirement-and-compliance.pdf?sfvrsn=4e9df3ba_2Denver: https://www.ucdenver.edu/coronavirusExemptions vary by campus location/department. Campus/Unit-Specific Exemptions:
Qualifications
Minimum QualificationsEntry Clinical Science Professional:One (1) year clinical research or related experience Senior Clinical Science Professional:Two (2) years clinical research or related experience *Applicants must meet minimum qualifications at the time of hire.Preferred Qualifications
Job Category: Research Services
Primary Location: Aurora
Schedule: Full-time
Posting Date: Jun 8, 2022
Unposting Date: Ongoing
University of Colorado | CU Anschutz Medical CampusDivision of Pulmonary Sciences and Critical Care MedicineOfficial Title: Research Services Clinical Science Professional (Open Rank)Working Title: Clinical Research Coordinator- Center for Lungs and Breathing (Open Rank: Entry-Senior Level)Position #00793004 – Requisition #24393* 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/3012---covid-19-vaccination-requirement-and-compliance.pdf?sfvrsn=4e9df3ba_2Denver: https://www.ucdenver.edu/coronavirusExemptions vary by campus location/department. Campus/Unit-Specific Exemptions:
- Anschutz Campus – Accommodations may be granted for medical or religious reasons.Denver Campus - Exemptions are allowed for medical, religious, or personal reasons.Consolidated/Central Services Administration – Accommodations may be granted for medical or religious reasons.
- Serving as the clinical research coordinator for industry sponsored and investigator-initiated clinical trials
- Assisting in the Maintenance of a clinical research specimen biorepository
- Other projects as assigned
- Assist with all regulatory activities required to implement and maintain the clinical research endeavors as part of the CLB.
- Assist with and oversee the day-to-day operations of clinical trials and studies
- Obtain study subject’s medical history and current medication information, reviews research protocol inclusion/exclusion criteria, and confirms eligibility of subject to participate in clinical trial
- 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 manner
- Adhere to research regulatory standards
- 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 guidelines
- Participate in subject recruitment efforts, including communicating with patients expressing an interest and all pre-screening/screening activities
- Ensure that the necessary supplies and equipment for studies are in stock and in working order
- Collaborating with principal investigators, co-investigators to enroll clinical trial patients
- Conducting study visits
- Overall compliance with the policy and procedures for conducting good clinical trials
- Screening, consenting and enrolling study participants
- Collecting, processing, and storing samples for research
- Medication compliance tracking and coordinating protocol procedures
- Collect and report all patient reported adverse drug reactions and other serious adverse events
- Patient education and follow-up per protocol guidelines
- Routine meetings with monitors to reconcile data management issues
- Participation in investigator’s meetings
- Preparing and submitting compliance documentation for the institutional review board
- Submission to the Human Research Subjects Portal for UCH-RSS review and approval
- Maintenance of databases
- Abstracting data from patient charts and electronic medical records
- Service in the following areas:
- Clinical Research Advisory Forum (RAF)
- Clinical Research Coordinators Committee (CRC)
- Support with local PH awareness and fundraising event
- Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies
- Independently perform study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies
- Assist Team Leads, Supervisors and/or management with creation and implementation of processes and procedures and quality improvement initiatives
- Act as a Primary Coordinator on multiple trials/studies
- Assist and train junior team members
- Assist with developing or develops protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Maintains subject level documentation and prepares documents, equipment and/or supplies
- Assist with identifying issues related to operational efficiency and shares results with leadership
- Collect information to determine feasibility, recruitment, and retention strategies. Employ, evaluate, and assist with the implementation of innovative solutions to maximize recruitment and retention
- Serve as a resource and participate in study initiation and close out duties
Qualifications
Minimum QualificationsEntry Clinical Science Professional:
- 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
- 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
- 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
- Bachelor’s degree in science or health related field
- Clinical research or related experience
- Experience with electronic data capture systems (e.g., EMR or EHR and data management systems)
- Prefer a minimum of two years’ experience with coordinating and managing administrative and clinical research activities.
- Advanced computer skills, particularly Microsoft Excel, PeopleSoft, and COGNOS.
- Knowledge and experience with IRB policies and procedures.
- Requires independent judgment as well as self-directed work capabilities.
- This position requires extensive experience with managing multiple projects and someone who can effectively multi-task
- Ability to establish work priorities and handle multiple deadlines.
- 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
Job Category: Research Services
Primary Location: Aurora
Schedule: Full-time
Posting Date: Jun 8, 2022
Unposting Date: Ongoing
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