Entry Clinical Science Professional - Aurora, United States - University of Colorado

Description

University of Colorado | CU Anschutz Medical Campus

School of Medicine | Department of Pediatrics | Section of Hematology, Oncology & Bone Marrow Transplantation

Official Title:
Research Services Entry Clinical Science Professional

Working Title:
Entry Clinical Science Professional - Hemophilia and Thrombosis Center

Position # Requisition #27282

• Applications are accepted electronically ONLY at

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:

Denver:
Exemptions 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

The School of Medicine's Department of Pediatrics, Section of Hematology, Oncology & Bone Marrow Transplantation has an opening for a full-time University Staff (unclassified) Research Services Entry Clinical Science Professional 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 Work

Entry 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.

The Hemophilia and Thrombosis Center (HTC) has an opening for a full-time Entry Clinical Science Professional. This position will be based at the HTC, which is located on the Anschutz Medical Campus.

The primary responsibilities of this position include the coordination of clinical research projects, specimen collection, processing, and tracking for the HTC's pediatric and adult thrombosis, stroke and brain injury, and bleeding disorder research projects.

This position will be responsible for providing research services for patients enrolled in studies or those eligible for hemophilia, thrombosis, and any coagulation-related research studies.

Examples of Duties Performed

• 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
• Educate patients and families on the research protocol requirements and their responsibilities.
• Administering questionnaires, performing 12-lead ECG, and taking vital signs, dependent upon study work is being performed for.
• 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
• Complete study-related documentation such as source documents, case report forms, and adverse event reports.
• Prepare and complete all IRB submissions including initial submissions, amendments, continuing reviews, unanticipated problems, and study closures.
• Prepare and complete Human Subjects Research Portal submissions.
• Prepare, submit, and maintain required documentation for FDA-regulated trials via IND/IDE applications, amendments, and annual reports
• Maintain required records of study activity including case report forms, drug accountability records, Investigator Site Files, and other regulatory documents.
• 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

Additional Examples of Duties Performed

• Coordinate investigator-initiated and industry-sponsored clinical research studies focused on patient outcomes and improving the care of pediatric and adult patients with bleeding and clotting disorders.
• Participate in and support all internal and external audits, inspections, and monitoring visits
• Blood sample collection, processing, and shipping in accordance with IATA regulations.
• Perform data entry, quality assurance, and assist with data analysis for study projects.
• Monitor and approve research financial charges and study subject payments.
• Help prepare for and possibly travel to outreach clinic locations and study-specific Investigator Meetings for training, as needed.

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

• 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

Applicants must meet minimum qualifications at the time of hire.

Conditions of Employment

• Must be willing and able to travel on occasion
• Must be willing and able to work Monday through Friday, 8am-5pm (with very rare extended hours)

Preferred Qualifications

• 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)
• Experience in managing multiple complex research projects concurrently.

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
• Ability to train and become proficient in ICH/GCP guidelines and the Informed Consent Process.
• Proficient in Microsoft Office.
• Conscientious and meticulous in data extraction and data entry.
• Ability to works well in a team environment, but also able to work independently.
• Ability to adhere to local and federal regulations and ethical codes with respect to the protection of human subjects and patient confidentiality and privacy.
• Resolve conflicts in a constructive manner.
• Ability to understand, learn and adhere to department Standard Operating Procedures
• Respond positively and adjust to meet new or unanticipated work challenges.
• Maintain proficiency in study-specific procedures and techniques, updating, learning, and implementing changes when industry, University, or Section standards change.

Salary and Benefits

The salary range (or hiring range) for this position has been established at $46,763 to $59,483.

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:

Total Compensation Calculator:
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

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, 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.