Clinical Research Coordinator (Open Rank: Entry-Intermediate Level) - Neurology

University of Colorado | CU Anschutz Medical Campus

School of Medicine | Department of Neurology

Official Title: Research Services Clinical Science Professional (Open Rank)

Working Title: Clinical Research Coordinator (Open Rank: Entry-Intermediate Level) - Neurology

Position #798660 – Requisition #26591

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_2

Denver: https://www.ucdenver.edu/coronavirus

Exemptions 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.

* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *

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 public education, clinical and research facility serving 4,500 students, and a world-class medical destination at the forefront of life-changing science, medicine, and healthcare. CU Anschutz offers more than 42 highly rated degree programs through 6 schools and colleges and receives over $500 million in research awards each year. We are the single largest health professions education provider in Colorado, awarding nearly 1,450 degrees annually. Powered by our award-winning faculty, renowned researchers and a reputation for academic excellence, the CU Anschutz Medical Campus drives innovation from the classroom to the laboratory to the delivery of unparalleled patient care. Read CU Anschutz Quick Facts here .

The School of Medicine’s Department of Neurology has an opening for a full-time University Staff (unclassified) Research Services Clinical Science Professional (Open Rank: Entry-Intermediate Level) to be a Clinical Research Coordinator for the department.

Jobs in the Research Services career family provide direct professional support of research activities.  Functions may include: regulatory compliance, sponsor communication and post and pre award management, human subject compliance, research laboratory study coordination and instruction, environmental health and safety, radiation control, hazardous materials use, disposal and training.

Professionals at all levels 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.

Professionals at the intermediate 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 intermediate level, duties are less limited in scope and are performed independently with occasional guidance and direction from other professionals.

Nature of Work

The Department of Neurology has an opening for a motivated full-time Clinical Research Coordinator to coordinate human subject’s clinical research studies, to include drug studies. This position is the lead coordinator responsible for overseeing and supporting assigned research studies. This position will collaborate with study colleagues at all levels of the organization. We are seeking an individual who is collaborative, communicative, caring, detail oriented and organized, proactive, able to think critically, focused on quality, dedicated to personal growth, and highly motivated in all areas of study coordination.

Examples of Duties Performed

Entry Level:

• Coordinate clinical research visits and collecting/recording data.  This position includes comprehensive direct patient contact (i.e., performing phlebotomy, taking vital signs, administering questionnaires and surveys, administering cognitive assessments, and coordinating drug and/or device dispensing and accountability) with a high-level of ethics and integrity
• 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
• Ensuring study quality meets the requirements of study protocols, department Standard Operating Procedures (SOPs), and research regulations and best practices (e.g., ICH guidelines, FDA code of Federal Regulations, and Good Clinical Practice (GCP)). Examples of this include proactively preventing deviations, creating source documents, creating backup plans, and ensuring principal investigator oversight
• Maintain detailed records of studies to ensure compliance with requirements of, 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, screening patients. Document patient enrollment statuses in collaboration with the recruitment specialist and protocol requirements.
• Ensure that the necessary supplies and equipment for studies are in stock and in working order
• Communicate and collaborate with various colleagues (e.g., principal investigator, clinicians, medical staff, sponsors, contract research organizations (CROs), neurology research staff, finance and billing professionals, and regulatory team) at various stages of each study assigned. The research services professional is responsible for providing excellent customer service to both internal and external stakeholders by presenting a positive image of the department and University
• Oversee 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
• Actively participate in subspecialty team meetings and neurology clinical research coordinator meetings. Collaborate with team members for study backup needs, sharing learning experiences, and applying learning opportunities

Intermediate Level - All of the above and:

• 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

This 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.

Minimum Qualifications

Entry Level

• Bachelor’s degree in biological science, psychology, or nursing, or related field.
  • A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis

Intermediate Level

• Bachelor’s degree in biological science, psychology, or nursing, or related field.
  • A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis
• One (1) year working in human subjects’ research and/or prior experience with direct patient contact

Preferred Qualifications

• Bachelor’s degree in science or health related field
• Three (3) years of clinical research or related experience
• Experience with electronic data capture systems (e.g., EMR or EHR and data management systems)
• Clinical research drug and/or device study coordination experience
• Research training: CITI, IATA, blood borne pathogens, Basic Life Support (BLS), GCP
• Experience completing documentation and performing tasks routinely used in clinical research, such as understanding federal regulations and Good Clinical Practice
• ACRP or SOCRA certification
• Background in Neuroscience
• Experience performing ECGs, phlebotomy, and vital signs
• Experience with Epic (UCH electronic medical record system) and CTMS systems (Oncore)
• Experience working with patients with Neurological conditions
• Experience with RedCap, FileMaker Pro, eCRF databases

Competencies, Knowledge, Skills, and Abilities

• Customer service skills
• Project management skills
• 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
• Respect patient rights and put patient safety first, 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
• Basic statistical skills
• Experience administering questionnaires or assessments (e.g., cognitive assessments)

Salary and Benefits

The salary range (or hiring range ) for this position has been established at:

• Entry – $44,403 - $56,481
• Intermediate – $48,321 – $61,464

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.

Benefits: https://www.cu.edu/employee-services/benefits

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 [email protected] ​.

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.