Clinical Research Coordinator Senior

Job ID 68639 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 four 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: Job Overview The Clinical Research Coordinator Senior is responsible for participating in the day-to-day operations of assigned clinical research programs and/or studies conducted by Principal Investigators (PIs) at the University of Colorado Anschutz Medical Campus. Performs a variety of administrative and operational duties involved in the collection, compilation, documentation and review of clinical research data. Supports the achievement of research program and/or study objectives. Leads others in navigating the clinical research environment and participates in a variety of departmental and/or divisional initiatives. Provides oversight to Clinical Research Coordinators and other related team members. Works under general 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. Submits studies for review and approval and provides status updates throughout the startup process.  Assists regulatory team with Institutional Review Board (IRB) preparation and submission. Screens, schedules, consents participants in a variety of clinical research programs and/or studies. Explains the difference between clinical activities and research activities, risk and benefits of study participation to participants. Develops and optimizes protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Maintains subject level documentation and prepares documents, equipment and/or supplies. Serves as a resource for and takes part in site initiation, monitoring, closeout visits, document storage activities, and related training, creation of Standard Operating Procedures (SOPs) and implementation of operational plans. Conducts and documents visits and testing/interviews according to all regulatory and organizational protocols. Collects, prepares, processes, ships and maintains inventory of research specimens. Collects information to determine feasibility, recruitment and retention strategies. Employs, evaluates and assists with the implementation of innovative solutions to maximize recruitment and retention. Assists participants with individual needs. Collects, prepares and/or processes Adverse Event (AE) information per protocol and provides input for AE reports. Completes and submits AE reports, according to institution and sponsor-specific reporting requirements. Serves as a resource regarding institutional and sponsor-specific reporting requirements. Develops IRB related documents. Maintains or collaborates to maintain appropriate documentation. Assists with identify issues related to operational efficiency and shares results with leadership. Maintains compliance with institutional requirements and policies. Develops and maintains a familiarity with the ethical conduct of research and safeguards needed when conducting clinical research. Serves as a resource and assists with the design of safeguards to ensure ethical conduct and to protect vulnerable populations. Participates in sponsor-required training and conducts literature reviews. Serves as a resource for issues related to professional guidelines and code of ethics. Identifies potential problems and risks to the participant, study and institution. Assists with the development and delivery of professional guideline and code of ethics training. Prepares, participates and leads team meetings. Proactively includes others in decision making and escalates issues to leadership as necessary. Assists with the development of proposals or protocols as directed. Identifies and communicates related shortcomings. Identifies various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of clinical research program and/or study aims. Assists with the determination of operational/statistical elements needed for conduct of clinical and translational programs and/or studies. 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. Develops systems and/or frameworks for quality assurance processes in collaboration with leadership. Adheres to, participates in and may oversee the development and assessment of quality assurance. Assists with recognizing trends related to data quality and escalates as appropriate. Recognizes when data agreements or special regulatory requirements are necessary and acts as a resource and mentor to determine when special contracts are necessary and escalates to stakeholders. Assembles the necessary parties to ensure that all required agreements are in place. Utilizes and assists with training team members on 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 or leads the development of data collection documents and instruments. Identifies issues related to data capture, collection or management, recommends solutions and assists with implementation. Assists with management of Investigational Products (IP). Utilizes required system for handling, dispensing and documenting IP for sponsored protocols. Maintains appropriate related documentation and tracks IP compliance at both protocol and subject level. Participates in and may provide oversight to monitoring financial study milestones, corresponding reporting and ensuring participant care expenses have appropriate financial routing. Participates in the development of budgets and financial monitoring systems. May provide significant contribution and influence upon research work, activities and/or productivity of study teams. Leads a committee or task force under direction of a supervisor. Leads scientific or programmatic presentations. Provides oversight, training and coaching to team members working in the clinical research environment, specifically with the concepts of program and/or study design. KNOWLEDGE, SKILLS & ABILITIES Knowledge of and ability to demonstrate proficiency in medical and clinical research related terminology. Knowledge of and ability to demonstrate proficiency in concepts of clinical research program and study design. Knowledge of and ability to recognize and employ professional guidelines and code of ethics related to the conduct of clinical research. Knowledge of and ability to maintain proficiency in best practices, trends and changes in the clinical research profession. Skilled in developing and implementing quality assurance processes. Ability to lead scientific or programmatic presentations and publications. Other Information SCOPE & LEVEL Guidelines:  Guidelines are generally numerous, well established, and directly applicable to the work assignment. Work assignment and desired results are explained by general oral or written instructions. Complexity:  Duties assigned are generally repetitive and restricted in scope but may be of substantial intricacy. Team member primarily applies standardized practices. Decision Making:  Decisions or recommendations on non-standardized situations are limited to relating organizational policies to specific cases. Brings non-routine issues to supervisor. Problems that are not covered by guidelines or that are without precedent are taken up with the supervisor.    Communication:  Contact with team members, clients or the public where explanatory or interpretive information is exchanged, gathered or presented and some degree of discretion and judgement are required within the parameters of the job description. Supervision Received:  Under normal supervision, within a standardized work situation, the team member performs duties common to the line of work without close supervision or detailed instruction. Work product is subject to continual review. Qualifications Education:  Bachelor’s degree in a related field is required. Experience:  Minimum of three (3) years of clinical research related experience is required. Equivalency:  Minimum of six (6) years of clinical research related experience may be considered in lieu of minimum education and experience requirements. Certification(s):  Designation as a Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) is required within six (6) months of hire. Certification in Basic Life Support for the Healthcare Provider by the American Heart Association is required at the time of hire. 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): $47,741.11 to $71,611.67 Hourly Salary Range: $22.95 to $34.43 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.

Salary : $23 - $34