Clinical Research Assistant

Job ID 68580 Location Aurora, Colorado Full/Part Time Full-Time Regular/Temporary Regular Why Work at Children's.... Here, it’s different. Come join us.     Children's Hospital Colorado has defined and delivered pediatric healthcare excellence for more than 100 years. Here, the nation’s brightest nurses, physicians, scientists, researchers, therapists and care providers are creating the future of child health. With an optimist’s outlook, a trailblazing spirit and a celebrated history, we’re making new strides every day. We’ve been Magnet-designated three times by the American Nurses Credentialing Center and are consistently recognized among the nation’s top 10 pediatric hospitals by U.S. News & World Report.  As a national leader in pediatric care, we serve children and families from all over the nation. Our System of Care includes four pediatric hospitals, 12 specialty care centers, 400 outreach clinics and 7,000 healthcare professionals representing the full spectrum of pediatric care specialties. We need your expertise. A career at Children's Colorado will challenge you, inspire you, and motivate you to make a difference in the life of a child. Here, it’s different. Do you have what it takes? Additional Information Department: RI-CCRO Hours per week: 40, eligible for benefits Shift: 40 hrs/week to support new and ongoing research in the Neuroscience Institute Job Overview The Clinical Research Assistant is responsible for providing administrative support for the day-to-day operations of assigned clinical research programs and/or studies conducted by Principal Investigators (PIs) at Children's Hospital Colorado. Performs a variety of administrative duties involved in the collection, compilation, documentation and review of clinical research data. Supports the achievement of research program and/or study objectives. Works under close and direct supervision. Responsibilities POPULATION SPECIFIC CARE Neonate - <30 days Infancy - >30 days to 1yr Toddlers - >1yr to 3yrs Pre-Schoolers - >3yrs to 5yrs School age - >5yrs to 13yrs Adolescent - >13yrs to 18yrs Adult - >18yrs to 65yrs ESSENTIAL FUNCTIONS An employee in this position may be called upon to do any or all of the following essential functions. These examples do not include all of the functions which the employee may be expected to perform. Assists regulatory team with Institutional Review Board (IRB) preparation and submission, including collation and preparation of documents. Screens and schedules participants in a variety of clinical research programs and/or studies. Consents subjects and/or families for registry or non-interventional research studies. Prepares for and takes part in site initiation, monitoring, closeout visits, and document storage activities. Conducts and documents visits and testing/interviews according to all regulatory and organizational protocols. Collects, prepares, processes, ships and maintains inventory of research specimens. Maintains subject level documentation and prepares documents, equipment and/or supplies. Provides input for and assists with developing IRB related documents. Collaborates with coordinating staff to maintain appropriate documentation. Assists to identify issues related to operational efficiency and shares results with supervising coordinator staff and/or management. Maintains compliance with institutional requirements and policies. Maintains a familiarity with the ethical conduct of research and safeguards needed when conducting clinical research. Participates in sponsor-required training. Participates in team meetings. Proactively includes others in decision making and escalates issues to management as necessary. Investigates incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data. Recognizes and reports vulnerabilities related to security of physical and electronic data. Adheres to and participates in the development and assessment of quality assurance. Assists with recognizing trends related to data quality and escalates as appropriate. Utilizes electronic data capture systems, technologies and software necessary for clinical research program and/or study operations. Scores tests, enters data and completes required forms accurately and according to protocol. Assists with the development of data collection documents and instruments. Identifies issues related to data capture, collection or management and escalates to supervising coordinator staff and/or management. Ensuring participant care expenses have appropriate financial routing and subjects are paid as relevant for participation in clinical trials. Other Information KNOWLEDGE, SKILLS & ABILITIES Ability to develop an understanding of and to utilize medical and clinical research related terminology. Ability to understand basic concepts of clinical research program and study design. Ability to recognize and employ professional guidelines and code of ethics related to the conduct of clinical research. Ability to maintain a general awareness of best practices, trends and changes in the clinical research profession. Ability to interact effectively with co-workers, student researchers, and study participants High level of comfort working with families from various backgrounds Must be team-oriented, detail-oriented, self-motivated and able to work independently Analytical mindset with problem-solving skills Ability to follow detailed and complicated protocols and instructions Proficiency with Microsoft Office 365 Suite: Word, Excel, Outlook, Teams Ability to adjust to new techniques or changes to research projects Ability to organize and prioritize a variety of projects and tasks, and meet deadlines Ability to represent the CHCO and the Breathing Institute in a professional and positive manner  Please be prepared to demonstrate ability in each of these areas if an invited for an interview. SCOPE & LEVEL Guidelines:  Trains in the field and assists higher level team members to acquire learning through practical experience. Complexity:  Performs routine and/or basic tasks common to the field. Procedures, methods and techniques to be used are well established with options to be considered well defined. Tools, work aids and materials to be used are specified. Decision Making:  Duties assigned are primarily routine, repetitive, and restricted in intricacy with little or no discretion in how they are carried out.    Communication:  Contact with team members, clients or the public where factual information relative to the organization or its functions are received, relayed, or a service rendered according to established procedures or instructions. Supervision Received:  Under close supervision, the team member receives training to develop skills and abilities in a specific line of work or general occupational area. Work product is subject to close, continuous inspection.    Qualifications Education:  High school diploma or equivalent is required. Physical Requirements Ability to Perform Essential Functions of the Job Audio-Visual: Color Discrimination: Good Audio-Visual: Depth Perception: Good Audio-Visual: Far Vision: Good Audio-Visual: Hearing: Good Audio-Visual: Near Vision: Good General Activity: Sit: 2-4 hrs. per day General Activity: Stand/Walk: 2-4 hrs. per day Motion: Bend: Up to 1/3 of time Motion: Carry: Up to 1/3 of time Use of Hands/Feet: Both Hands - Gross Motor Function Use of Hands/Feet: Both Hands - Precise Motor Function (Or Fine Manipulation) Weight Lifted/Force Exerted: Up to 25 pounds: Up to 1/3 of time Work Environment Equipment: Telephone, computers, reading reports/graphs Exposure: Exposure to blood/body fluid: Regular/Frequent Exposure: Exposure to chemicals: Occasional Exposure: Exposure to infectious diseases: Occasional Exposure: Exposure to radiation: Occasional Exposure: Exposure to skin irritations: Occasional Mental and Emotional Requirements: Handles multiple priorities effectively Mental and Emotional Requirements: Manages stress appropriately Mental and Emotional Requirements: Works alone effectively Mental and Emotional Requirements: Works in close proximity to others and/or in a distracting environment Mental and Emotional Requirements: Works with others effectively Mental and Emotional Stress: Managing workload and system issues Mental Stress: Multi-tasking, meeting deadlines, prioritizing Equal Employment Opportunity It is our intention that all qualified applicants be given equal opportunity and that selection decisions be based on job-related factors. We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status protected by law or regulation.  Be aware that none of the questions are intended to imply illegal preferences or discrimination based on non-job-related information. Salary Information Annual Salary Range (Based on 40 hours worked per week): $32,313.06 to $48,469.60 Hourly Salary Range: $15.54 to $23.30 Benefits Information As a Children’s Hospital Colorado team member, you will receive a competitive pay and benefits package designed to take care of your needs that includes base pay, incentives, paid time off, medical/dental/vision insurance, company provided life and disability insurance, 403b employer match (retirement savings), and a robust wellness program.