Professional Research Assistant
University of Colorado School of Medicine
University of Colorado | CU Anschutz Medical Campus
School of Medicine, Department of Pediatrics
Section of Hemophilia & Thrombosis Center (HTC)
Professional Research Assistant
Position #00600396– Requisition #20868* 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 Department of Pediatrics, Section of Hemophilia & Thrombosis Center (HTC) has an opening for a full-time Professional Research Assistant position. Nature of Work:
- 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.
- 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. 18%
- Participate in patient outpatient clinic visits to consent, enroll, & coordinate research activities. 23%
- Complete study-related documentation such as source documents, case report forms, and adverse event reports. 2%
- Prepare and complete all IRB submissions including initial submissions, amendments, continuing reviews, unanticipated problems, and study closures. 10%
- Prepare and complete Human Subjects Research Portal submissions. 1%
- Prepare, submit, and maintain required documentation for FDA-regulated trials via IND/IDE applications,amendments, and annual reports. 1%
- Maintain required records of study activity including case report forms, drug accountability records, Investigator Site Files, and other regulatory documents. 5%
- Participate in and support all internal and external audits, inspections, and monitoring visits. 2%
- Educate patients and families on the research protocol requirements and their responsibilities. 2%
- Schedule patient examinations, treatments, and laboratory tests required by study protocols. 1%
- Obtaining informed consent/assent, assessing eligibility, interviewing subjects to obtain medical history, administering questionnaires, performing 12-lead ECG, and taking vital signs, dependent upon study work is being performed for. 20%
- Blood sample collection, processing, and shipping in accordance with IATA regulations. 10%
- Perform data entry, quality assurance, and assist with data analysis for study projects. 2%
- Monitor and approve research financial charges and study subject payments. 1%
- Help prepare for and possibly travel to outreach clinic locations and study-specific Investigator Meetings for training, as needed. 2%
- Bachelors Degree (BS/BA) degree in science, social sciences, or related area.
- Must successfully pass a drug test through Children’s Hospital Colorado
- Must be willing and able to pass a national criminal background check
- Experience working with EPIC or similar electronic medical record system.Experience in managing multiple complex research projects concurrently.
- 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.
- Excellent written and oral communication skills.
- Ability to maintain positive working relationships with sponsors, clinical research officers, and other team members.
- 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.
- 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.
Job Category: Faculty
Primary Location: Aurora
Posting Date: Apr 23, 2021
Unposting Date: Ongoing