Clinical Research Coord Sr. - Multidisciplinary

About the role

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.

Responsibilities

• 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.
• 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. Collects information to determine feasibility, recruitment, and retention strategies. Collects, prepares, processes, ships, and maintains inventory of research specimens.
• 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.
• 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.
• 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.
• Provides oversight, training and coaching to team members working in the clinical research environment, specifically with the concepts of program and/or study design.

Requirements

• Three (3) years of clinical, clinical support, and or clinical research related experience.

Qualifications

• Associate degree in a related field with (5) five years of clinical related experience may be considered in lieu of minimum education requirement.

Skills

• Experience with electronic data capture systems, technologies, and software.
• Ability to navigate and understand clinical research protocols and regulations.
• Strong communication and interpersonal skills.
• Ability to manage multiple projects and tasks simultaneously.
• Knowledge of institutional and sponsor-specific reporting requirements.

Benefits

Here, you matter. 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, paid parental leave, 403b employer match (retirement savings), a robust wellness program, and access to professional development tools, including an education benefit to help you advance your career.

Pay

Pay is dependent on applicant's relevant experience.

Schedule

Multidisciplinary 3.0 - supporting Nephrology, Rheumatology, and Orthopedics
Monday - Friday
8:00 a.m. - 5:00 p.m.