University of Colorado School of Medicine**
University of Colorado | CU Anschutz Medical Campus
Job Title (Working and/or Official)
Position #732426 – Requisition #15910
Applications are accepted electronically ONLY atwww.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 Section of Hematology, Oncology, and Bone Marrow Transplantation - Hemophilia & Thrombosis Center/ /has an opening for a full-time Professional Research Assistant position.//
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 Hemophilia and Thrombosis Center (HTC) has an opening for a full-time Professional Research Assistant. 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 Work 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 patient outpatient clinic visits to consent, enroll, and coordinate research activities.
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 and support all internal and external audits, inspections, and monitoring visits.
Educate patients and families on the research protocol requirements and their responsibilities.
Schedule patient examinations, treatments, and laboratory tests required by study protocols.
Obtaining informed consent/assent, assessing eligibility, interviewing subjects to obtain medical history, administering questionnaires, performing 12-lead ECG, and taking vital signs, dependent upon the study work is being performed for.
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.
PLEASENOTE: Candidates may be responsible for travel expenses related to the interview process and any relocation expenses, if applicable.
Salary and Benefits:
The hiring salary for this position is negotiable and commensurate with skills and experience. 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.
The University of Colorado Denver 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.
The Immigration Reform and Control Act requires that verification of employment eligibility be documented for all new employees by the end of the third day of work. Alternative formats of this ad are available upon request for persons with disabilities.
Total Compensation Calculator:https://www.cu.edu/employee-services/total-compensation(for questions, please contactJessica.Martella@childrenscolorado.org)**
Diversity and Equity:
Please click here for information on disability accommodations:http://www.ucdenver.edu/about/departments/HR/jobs/Pages/JobsatCUDenver.aspx
TheUniversity of Colorado Denver | Anschutz Medical Campusis 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.
B.S. or B.A. degree in science, social sciences, or related area.
Proficient in Microsoft Office.
_Conditions of Employment:_
Must be willing and able to pass a 10-panel drug test through Children's Hospital Colorado.
Must be willing and able to pass a national criminal and sex-offender background check.
_Competencies - Knowledge, Skills, and Abilities:_
Ability to train and become proficient in ICH.GCP guidelines and the Informed Consent Process.
Conscientious and meticulous in data extraction and data entry.
Excellent written and oral communication skills.
Ability to maintain positive working relationships with sponsors, clinical research officers, and other team members.
Ability to work well in a team environment, but also be 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.
Communicate effectively and interact with investigators, hospital and clinic staff, sponsoring agencies, and others to perform clinical research.
Maintain proficiency in study-specific procedures and techniques, updating, learning and implementing changes when industry, University, or Section standards change.
2 years relevant clinical research experience or 2 years experience working in the hemophilia and/or thrombosis field.
Experience working with EPIC or similar electronic medical record system.
Experience in managing multiple complex research projects concurrently.
Organization: *U0001 -- Denver-Anschutz Administration
Title: Professional Research Assistant - Hemophilia & Thrombosis Center
Requisition ID: 15910