University of Colorado | CU Anschutz Medical Campus
Clinical Research Support Team (CReST) - OVCR
Job Title: Clinical Research Coordinator
Position #00804565 – Requisition #28245
* 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 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 Clinical Research Support Team has an opening for a full-time University Staff (unclassified) Clinical Research Coordinator position.
Jobs in this 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.
Position Emphasis
The Clinical Research Support Team (CReST) is part of Office of the Vice Chancellor of Research (OVCR). CReST provides a la carte support services to clinical investigators for all activities related to the successful conduct of clinical research, from study start-up through close out. This is the cornerstone to translate basic science knowledge into clinically useful treatment for patients.
The Clinical Research Support Team (CReST) has an opening for a full-time Clinical Research Coordinator to provide study coordination, and data collection/entry support for a variety of drug, device and biologic studies conducted at the University of Colorado Anschutz Medical Campus and affiliate hospitals.
We are seeking an individual who is collaborative, communicative, caring, detail oriented and organized, proactive, able to think critically, focused on quality, passionate about research, dedicated to personal growth, and highly motivated in all areas of study coordination.
Examples of Duties Performed
Acts as primary contact and/or liaison for investigators, sponsor representatives, and study subjects for assigned research studies. Relays timely information to and between appropriate stakeholders.
Alongside other coordinators and with direct supervision from the Operations Manager this position performs study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies This position involves frequent, comprehensive direct patient contact. A high level or ethics and integrity is essential to protecting the rights and welfare of subjects and ensuring satisfactory clinical trial conduct.
Coordinates and conducts clinical research visits with potential and enrolled study participants.
Recruits prospective subjects for a variety of research clinical trials. Educates potential subjects on the details of the studies through phone contacts and personal interviews
Reviews protocol inclusion/exclusion criteria, and confirms eligibility of subject to participate in clinical trial
Performs 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
Manages scheduling of participants, tracks subject participation, and participates in monitoring visits
Ensures that the necessary supplies and equipment for studies are in stock and in working order
Oversees lab activities, such as basic processing technique (e.g., centrifuge, aliquot serum, blood slides, etc.) and/or transporting blood specimens to the lab, and shipping and tracking laboratory samples
Accurately enters source data into Case Report Form (CRF) or study database in a timely manner. Reviews records after each visit for completeness and accuracy. Maintains participant research files. Reviews and resolves database queries
Recognizes adverse events and serious events and promptly notifies appropriate parties, allowing for compliance with applicable reporting timelines
Alongside other coordinators and with direct supervision from the Operations Manager this position reviews study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies
Actively participates in site initiation, closeout, and other ongoing and individual research team meetings. Serve as a resource and participate in study initiation and close out duties
Assures compliance with applicable regulations (FDA; OHRP, etc.), external and internal policies (NIH; CU and hospital affiliates, IRBs, etc.) departmental Standard Operating Procedures (SOPs), and research standards and best practices (ICH Good Clinical Practice (GCP), and Good Documentation Practices (GDP), etc.)
Maintains study-specific regulatory binders
Assists with developing protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs)
Collaborates with CReST colleagues to ensure appropriate study coverage and backup
Accurately tracks billable time by study.
Provides excellent customer service to both internal and external stakeholders by presenting a positive image of the department and University
Exercises independent critical thinking and decision making to ensure the successful conduct of assigned studies and of the CReST coordinator program
Other duties, as assigned
Minimum Qualifications
A bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution
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
Experience with electronic data capture systems (e.g., EMR or EHR and data management systems)
Clinical research drug and/or device study coordination experience
Lab and sample collection and processing experience
Research training: CITI, GCP
Experience completing routine clinical research tasks and documentation, such as conducting informed consent or assessing eligibility
Bilingual (Spanish & English)
Knowledge, Skills, And Abilities
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
Additional Competencies
Ability to interpret and master complex research protocol information
Respect for patient rights and dedication to patient safety and protections; excellent patient rapport
Empathetic to patients with chronic illnesses
Great attention to detail and quality
Ability to work with colleagues and patients in a confidential and professional manner
Ability to follow and execute a study protocol and proactively prevent deviations
Ability to follow direction of the PI and direct supervisor, follow all department SOPs and department policies
Critical thinking and sound judgement
Outstanding organizational and time management skills
How To Apply
For full consideration, please submit the following document(s):
A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position (only use if a cover letter is necessary)
Curriculum vitae / Resume
Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address
Questions should be directed to: John Sorrentino – John.Sorrentino@cuanschutz.edu
Salary And Benefits
The salary range (or hiring range) for this position has been established at $51,000. 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.
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.
Total Compensation Calculator: http://www.cu.edu/node/153125
Diversity and Equity
The 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, faulty 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, persons within the LGBTQ+ community, 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.
University Staff
Special Instructions to Applicants
Required Application Materials: To apply, please visit: http://www.cu.edu/cu-careers and attach: 1. A letter of application which specifically addresses the job requirements and outlines qualifications 2. A current CV/resume 3. List of three to five professional references (we will notify you prior to contacting both on and off-list references)
Job Category
Research Services
Primary Location
Aurora
Department
U0001 -- Anschutz Med Campus or Denver
Schedule
Full-time
Posting Date
Aug 29, 2024
Unposting Date
Ongoing
Posting Contact Name
John Sorrentino
Posting Contact Email
john.sorrentino@cuanschutz.edu
Position Number
00804565
Seniority level
Entry level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Higher Education
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