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Job Summary:
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The Pediatric Neurosciences Clinical Research team involves investigator initiated, NIH and federally funded clinical research projects. Topics include neurogenetics, epilepsy, headache, neuromuscular, neuroimmunological and general neurology studies. Clinical Sciences Professionals are assigned to specific studies in consultation with the research manager, the research director and the PIs involved in each study. The Clinical Sciences Professional will be the primary coordinator on 2-4 research studies and back-up on 2-4 research studies. For day-to-day duties on each study, the Clinical Sciences Professional will report to the PI involved in that study with back-up provided by the research manager.
Key Responsibilities (Both Intermediate and Senior Levels):
- 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.
- 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 or Backup Coordinator on multiple trials/studies.
- Assist and train junior team members.
Senior Level Responsibilities:
- 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.
Additional Duties and Responsibilities (Intermediate and Senior Levels):
- Assist the PIs with preparation of abstracts, posters and manuscripts, under the direction of the PIs and/or independently.
- Travel to scientific or project related meetings.
- Travel to program sites in accordance with program project management.
The 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.
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Why Join Us:
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The Department of Pediatrics, was ranked No. 7 in the nation for "Best Medical Schools - Pediatrics" in U.S. News & World Report's 2022 rankings. The Section of Child Neurology is nationally recognized for providing outstanding consultation, clinical care, and surgery for children and adolescents with neurological disorders. U.S. News & World Report ranked Child Neurology as one of the top 10 programs in the nation. As the largest medical center in the western region providing such broad expertise, The Department of Pediatrics, Section of Neurology is the referral center for children and adolescents with neurological disorders for much of the western U.S.
The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off - vacation, sick, and holidays and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness.
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Diversity and Equity:
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The University of Colorado 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, persons within the LGBTQ+ community and all veterans. The University of Colorado is committed to diversity and equality in education and employment.
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Qualifications:
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Minimum Qualifications:
Intermediate Level:
- Bachelor's degree in any field.
- Substitution: 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 of clinical research or related experience.
Senior Level:
- Bachelor's degree in any field.
- Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.
- Two (2) years of clinical research or related experience.
Applicants must meet minimum qualifications at the time of hire.
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).
- Experience with federal regulations related to IRB and clinical research.
- Experience with institutional, university, and governmental research administration policies and procedures.
- Experience with clinical research database design and implementation (RedCAP); data cleaning.
- Prior multi-site project management experience.
- ACRP or SOCRA Certification.
- Experience in pediatric neurologic disease.
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, and medical terminology.
- Ability to interpret and master complex research protocol information.
- Exceptional organizational skills.
- Knowledge or willingness to learn how to use organizational tools like (OneNote, Microsoft Teams, Outlook).
- Ability to balance customer service with project deadlines.
- Ability to pay close attention to study details and strictly follow IRB/FDA regulations.
- Ability to relate to individuals with diverse backgrounds.
- Must be able to work independently with minimal supervision.
- Ability to work as a member of a team.
- Ability to work on multiple projects concurrently and prioritize tasks as appropriate.
- Must be able to work comfortably in a stressful and time-pressured environment.
- Must be comfortable discussing issues and concerns directly with the researcher and be committed to the ethical principles enforcing the scientific research project.
- Must possess a high degree of independent judgment and decision-making capabilities.
- Requires strong operational skill set, including proactive abilities, discretion, superior organization/coordination, quality/process improvement, problem-solving, analytical, customer service and time management skills.
- Ability to master new software systems.
- Proficient use of computer and relevant software and database applications (such as EPIC, MS Word, Excel, PowerPoint, etc.).
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How to Apply:
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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
- 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: Steph Salazar steph.salazar@cuanschutz.edu
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Screening of Applications Begins:
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Immediately and continues until the position is filled. For best consideration, apply by December 6, 2022.
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Anticipated Salary Range:
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The hiring range for this position has been established at:
- Intermediate Level: $51,239 - $65,176
- Senior Level: $55,393 - $70,460
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 may be eligible for overtime compensation depending on the level.
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
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ADA Statement:
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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.
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Background Check Statement:
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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.
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Vaccination Statement:
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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
Unit-Specific Exemptions:
- Anschutz Campus - Accommodations may be granted for medical or religious reasons.
The University of Colorado 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
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