Clinical Research Coordinator Heart Institute

at  Childrens Hospital Colorado

JOB OVERVIEW

The Clinical Research Coordinator is responsible for participating in the day-to-day operations of routine, minimally complex 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. Works under close supervision, receiving instruction, guidance and direction from Senior CRC, Clinical Research Supervisor and/or leadership team.
We are looking for a motivated, detail-oriented, highly organized, team-oriented person to join the Heart Institute Research team, here at Children’s Hospital Colorado! As a leader in pediatric heart care, our Institute is the largest in the region, treating more than 20,000 patients each year. And because we’re dedicated to training tomorrow’s leaders, our heart fellowship program has educated hundreds of pediatric cardiologists who are changing the lives of children with heart disease across the country. We are also one of only eight stand-alone pediatric research centers in the country and we are committed to improving the lives of all kids and families with heart disease. Our extraordinary team at Children’s Hospital Colorado is creating the future of child health, and we need top talent to do it. Join us!

QUALIFICATIONS

Education: Bachelor’s degree in a related field is required.
Equivalency: High School diploma or GED, and four (4) years of clinical, clinical support, or clinical research related experience may be considered in lieu of minimum education requirement.

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.
1.Documentation/Data Collection - Prepares and takes part in site initiation, monitoring, closeout visits, document storage activities, and related training. May assemble the necessary parties to ensure that all required agreements are in place. Utilizes and assists senior 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 the development of data collection documents and instruments, maintains subject level documentation, and prepares documents, equipment and/or supplies identifies issues recommends solutions.
2. Regulatory - Submits assigned studies for review and approval and provides status updates throughout the startup process. Assists regulatory team with Institutional Review Board (IRB) preparation and submission.
3. Study Participation - Screens, schedules, consents participants in assigned clinical research programs and/or studies. With guidance, explains the difference between clinical activities and research activities, risk and benefits of study participation to participants. Engages with senior study team to maintain participant recruitment and retention rates and assists with participants with individual needs, collects information to determine feasibility. Collects information to determine feasibility, recruitment, and retention strategies. Collects, prepares, processes, ships, and maintains inventory of research specimens.
4. Protocol - Trains in developing protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Conducts and documents visits and testing/interviews according to all assigned regulatory and organizational protocols. Trains in completing and submitting AE reports, according to institution and sponsor-specific reporting requirements. Assists with the development of proposals or protocols as directed. Identifies and communicates related shortcomings. Maintains appropriate related documentation and tracks IP compliance at both protocol and subject level.
5. Human Subject Research Protection - 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. Trains in the design of safeguards to ensure ethical conduct and to protect vulnerable populations and participates in sponsor required training. Trains on professional guidelines and code of ethics.
6. Team Coordination - Proactively includes others in decision making and escalates issues to leadership as necessary. Learns various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of clinical research program and/or study aims.
7. Quality Assurance - 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. Assists with recognizing trends related to data quality and escalates as appropriate. Adheres to and participates in the development and assessment of quality assurance. Assists with identifying issues related to operational efficiency and shares results with team members.
8. Budgets/Financials - Participates in monitoring financial study milestones, corresponding reporting and ensuring participant care expenses have appropriate financial routing.

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