Professional Research Assistant
- Employer
- University of Colorado Anschutz Medical Campus
- Location
- Denver, CO
View more
- Administrative Jobs
- Academic Affairs, Research Staff & Technicians
- Employment Type
- Full Time
- Institution Type
- Four-Year Institution
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Description
Qualifications
Minimum Qualifications:
Job Category: Faculty
Primary Location: Aurora
Schedule: Full-time
Posting Date: Jul 22, 2021
Unposting Date: Ongoing
University of Colorado School of Medicine
University of Colorado | CU Anschutz Medical Campus
School of Medicine, Department of Pediatrics
Section of Infectious Disease– Clinical Trials Center
Professional Research Assistant
Position #00785891– Requisition #22079* 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 Infectioius Disease– Clinical Trials Center has an opening for a full-time Professional Research Assistant position. Nature of Work:- The Clinical Trials Center performs clinical research trials focusing on vaccines in adults and older adults for disease entities such as shingles, influenza, pneumonia, and other viruses. The Research Nurse will coordinate clinical trial development and implementation, from IRB submission to recruitment to enrollment and study procedures.
- 20% - Development of regulatory submissions for a given study to the IRB, HSR portal, OnCore, etc. This might involve editing an industry consent to make it fit with COMIRB requirements, processing amendments to the protocol, reporting serious adverse events, etc.
- 5% - Maintain study regulatory binder, organizing all pertinent IRB submissions and documents, communication, notes to file, safety documents, etc.
- 5% - Develop study source documents independently, or based on sponsor's electronic data capture system; may be hard copy or electronic depending on the study
- 5% - Develop and implement a recruitment plan (within budgetary guidelines) for meeting study enrollment goals via advertising, community presence, mailings etc.
- 5% - Engage in informed consent process with potential participants, in keeping with Good Clinical Practices
- 5% - Gather health history and other data to assess for study eligibility, working closely with Principal Investigator to assure eligibility criteria are met
- 10% - Schedule and perform study visits as required by the protocol. This may involve consenting, procedures such as phlebotomy, specimen handling/storage/transport, vaccine or medication administration.
- 3% - Educate study participants on expected participant responsibilities such as use of vaccine diaries (electronic or hard copy), reporting health changes
- 5% - Maintain vaccine accountability records to assure cold-chain, preparation, administration and disposition of investigational product, as required by the protocol
- 7% - Maintain precise, accurate documentation and record keeping
- 3% - Educate and train other staff in study-specific details, and document same
- 10% - Demonstrate excellent customer service skills with study participants, sponsoring companies, and regulatory agencies
- 2% - Development of study-specific standard operating procedures, Notes to File
- 15% - Work closely with PI regarding all aspects of research study implementation. This may include helping to develop a budget for a potential study, facilitating adequate detail and timely reporting related to adverse events or serious adverse events
Qualifications
Minimum Qualifications:
- Education - Bachelor's degree in Nursing or related field
- Experience - 3 years nursing experience, 2 years clinical research experience
- Special skills - Colorado RN license
- Phlebotomy skills of at least 1 year
- Basic Life Support certification
- Must successfully pass a drug test through Children’s Hospital Colorado
- Must be willing and able to pass a national criminal background check
- 4+ years nursing experience or 5+ years clinical research experience
- Spanish speaking
- Experience with electronic medical record
- Excellent writing and communication skills
- Attention to detail, ability to follow-through
- Able to work independently, obtaining guidance as needed
- Ability to manage multiple projects and accurately prioritize workflow
- Flexibility
- Professional demeanor, positive people skills
- Proficient at computer applications including Microsoft Office, internet, email
Job Category: Faculty
Primary Location: Aurora
Schedule: Full-time
Posting Date: Jul 22, 2021
Unposting Date: Ongoing
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