Senior Clinical Research Coordinator Heart Institute

JOB OVERVIEW

The Clinical Research Coordinator Senior is a seasoned Coordinator who can work across multiple complex modalities and is responsible for participating in the day-to-day operations of complex, multi-site 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. Facilitates the accomplishment of research programs and/or study goals. Works independently and 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 minimal supervision.
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.
Experience: Minimum of three (3) years of clinical, clinical support, and or Clinical Research related experience is required.
Equivalency: Associate degree in a related field with (5) five years of clinical 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.

• Documentation/Data Collection - Prepares and takes part in site initiation, monitoring, closeout visits, and document storage activities, and related training, creation of SOPs and implementation of operational plans. 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. Leads the development of data collection documents and instruments, maintains subject level documentation, and prepares documents, equipment and/or supplies, identifies issues recommends solutions.
• Regulatory - Identifies and liaises with various regulatory partners (IRB, compliance, legal) as needed for clarity in effectively supporting research operations. Identifies gaps and participates in policy, standard operating procedures and guideline development as required to enhance research operations in the CHRE. 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.
• Study Participation - 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. Conducts difficult, sensitive conversations with patients/families. Employs, evaluates, and assists with the implementation of innovative solutions to maximize recruitment and retention, and assists participants with individual needs. Collects information to determine feasibility, recruitment, and retention strategies. Collects, prepares, processes, ships, and maintains inventory of research specimens.
• Protocol - Develops and optimizes 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 regulatory and organizational protocols. Completes and submits along with regulatory team the AE reports, according to institution and sponsor-specific reporting requirements. Serves as a resource regarding institutional and sponsor-specific reporting requirements. Assists with the development of proposals or protocols. Identifies and communicates related shortcomings. Maintains appropriate related documentation and tracks IP compliance at both protocol and subject level.
• 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. Serves as a resource and assists with the design of safeguards to ensure ethical conduct and to protect vulnerable populations and participates in sponsor required training. Serves as a resource and trainer for issues related to professional guidelines and code of ethics. Identifies and facilitates resolution of potential problems and risks to the participant, study and/or institution.
• Team Coordination - Leads team meetings. Proactively includes others in decision making and escalates issues to leadership as necessary. Provides 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. Identifies various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of Clinical Research program and/or study aims. Implements with leadership team on the operational elements needed for the conduct of clinical and translational programs and/or studies.
• Quality Assurance - Investigates incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data and assists management with resolution. Recognizes and reports vulnerabilities related to security of physical and electronic data. Assists with recognizing trends related to data quality and develops and implements retraining as appropriate. Adheres to and oversees the development and assessment of quality assurance processes. Identifies issues related to operational efficiency and shares results with team members and management. 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. Develops systems and/or frameworks for quality assurance processes in collaboration with leadership.
• Budgets/Financials - Participates in and provides oversight to monitoring financial study milestones, corresponding reporting and ensuring participant care expenses have appropriate financial routing. Comprehensive understanding of institutional process for the development of budgets. Proactively identify gap deficits and escalating.
• Mentoring/Coaching - Provides oversight, training and coaching to team members working in the Clinical Research environment, specifically with the concepts of program and/or study design.

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