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University of Colorado Senior Clinical Research Coordinator (Senior PRA) in Aurora, Colorado

University of Colorado – School of Medicine

Senior Clinical Research Coordinator (Senior PRA)

The University of Colorado Denver l Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty and staff of diverse backgrounds.

The University of Colorado’s Division of Gastroenterology and Hepatology in the Department of Medicine, located at the Anschutz Medical Campus, is an internationally renowned program that provides comprehensive resources for the diagnosis and therapy of diseases of the digestive tract, pancreas and liver. The Division of Gastroenterology and Hepatology has faculty and staff making contributions to research, clinical trials, and nationally recognized patient care. The Division of Gastroenterology and Hepatology is rapidly growing, with clinical practices throughout the state of Colorado and over 80 researchers, physicians and staff, all working toward its vision to prevent and treat disease while being a global model for patient care delivery, interdisciplinary research, and training.

As an important member of the research team, the Clinical Research Coordinator works with industry-sponsored, co-operative group and/or investigator-initiated clinical trials in accordance with the trial protocols, FDA Regulations, and ICH/GCP Guidelines. This position is accountable for meeting study-specific goals and timelines, while also performing and assisting with clinical tasks related to study-specific tests, procedures, and treatments as assigned based on appropriate licensure and/or completion of competency documentation and team needs. This position communicates appropriately and effectively with study subjects, investigators, and other team members and has outstanding customer service skills and accepts responsibility in maintaining relationships that are equally respectful to all.

The Division of Gastroenterology and Hepatology is seeking to employ a full timeSenior Professional Research Coordinator. This position is responsible for the implementation and coordination of clinical trials and investigator initiated studies conducted by Dr. Sachin Wani and colleagues at the University of Colorado.

_Examples of Work Performed_

  • Obtains study subject medical history and current medication information, reviews research protocol Inclusion/Exclusion Criteria, and confirms eligibility of subject to participate in clinical trial. Performs informed consent process or ensures that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required

  • Provide day to day oversight of Dr. Wani’s study coordinators

  • Provides education on study protocol to clinical research coordinators and potential subjects on the details of the studies.

  • Familiar with protocol and all study documents and reviews documents for completeness and accuracy

  • Reports subject Adverse Events (AEs) and Serious Adverse Events (SAEs) to appropriate parties (e.g., Principal Investigator, Study Sponsor, Food and Drug Administration (FDA), Data and Safety Monitoring Committee (DSMC), Regulatory Affairs Coordinator, etc.)

  • Meets with Monitors to respond to any question of data validity and corrects/revises data as appropriate; responds to queries from Sponsor

  • Works on multiple research studies simultaneously

  • Serves as a primary liaison with Sponsors, Contract Research Organization (CRO), external research site partners and Division Administration Research Team (DART) for ongoing clinical research studies

  • Assists with Sponsor, Data Safety Monitoring, and Food and Drug Administration (FDA) audits and responses

  • Develops protocol-specific Source Documents (e.g., data collection tools, study visit checklists, etc.)

  • Assists Research Manager and/or Financial Team by processing invoices and answering billing questions related to procedure performed for subjects enrolled in clinical trials

  • Serves as Primary Contact for all Dr. Wani’s study protocols

_Examples of Senior Professional Research– Specific Work_

  • Assists Research Manager with creation of training process documents and tools

  • Trains, assesses, and mentors new Clinical Research Coordinators, as directed by Manager and PI.

  • Works to balance competing constraints on the projects with available resources.

  • Prepares and leads kick off and regular project team meetings with external sites and sponsors

  • Specific responsibilities include, but are not limited to:

  • Project initiation (e.g. IRB approval, Clinical Trial registration, research staff training, creating manuals of operation)

  • Monitor project scope, timelines and deliverables from project initiation to close out.

  • Project planning/coordination (e.g. schedules, project meetings)

  • Project execution (e.g. carrying-out/overseeing daily research activities, stakeholder engagement activities, team communication activities, coding qualitative interviews)

  • Ensure the overall quality of project services and deliverables

  • Participate in the design, writing and/or review of all project-related essential documents including protocols, project management plans, case report forms, statistical analysis plans, Project Management Plans, ICF templates, Study Procedure Manuals, source documents, site newsletters, study reports and monitoring plans and report templates.

  • Monitoring/controlling (e.g. tracking budgets, managing and tracking data collection and protocol adherence, developing status reports for the PI and Research Manager, regulatory reporting, data quality assurance activities, reporting to funding organization, performance management of PRAs/trainees)

  • Interpretation and dissemination of findings (e.g. literature reviews, qualitative data analysis, manuscript drafting)

  • Lead and direct the development of trial specific procedures related to project management activities and responsibilities.

  • Coordinate the development and maintenance of study specific documents, including, protocols, informed consent forms, and manual of procedures.

  • Other related work will be assigned by Dr. Wani and Research Manager as required by the nature and scope of the position.Serves as role model to all Clinical Research Coordinators – remains in compliance with all training requirements, meets established deadlines for data submission, possesses a strong understanding of clinical research history, regulations, and ethics

Salary and Benefits:

Salary is commensurate with skills and experience. The University of Colorado offers a full benefits package. Information on University benefits programs, including eligibility, is located atEmployee Services.

University of Colorado Denver | Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background checks for all new employees prior to their employment.

The Immigration Reform and Control Act requires that verification of employment eligibility be documented for all new employees by the end of the third day of work. Alternative formats of this ad are available upon request for persons with disabilities.

Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.

Benefits:https://www.cu.edu/employee-services/benefits.

Total Compensation Calculator:https://www.cu.edu/employee-services/total-compensation

Diversity and Equity:**

Please click here for information on disability accommodations:http://www.ucdenver.edu/about/departments/HR/jobs/Pages/JobsatCUDenver.aspx

The University of Colorado Denver | Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

_Minimum Requirements_

  • A master degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution.

  • 2 years of clinical and/or basic science research experience

  • *

_Preferred Qualifications: _

  • 3 years of clinical and/or basic science research experience

  • Project/program management experience

  • Experience with qualitative methods and data collection using interviews, diaries, and surveys

  • Experience working with the study population

  • Experience working in an academic setting

  • Experience working in clinical settings

  • Experience using REDCap

_Knowledge, Skills and Abilities_

  • Ability to communicate effectively, both in writing and orally.

  • Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.

  • Outstanding customer service and patient relations skills.

  • Demonstrated commitment and leadership ability to advance diversity and inclusion.

  • Excellent organizational skills, ability to problem-solve, multi-task, and work independently.

  • Good command of the English language, both written and verbal.

  • Excellent attention to detail.

  • Ability to interpret and comprehend complex research protocol information.

  • Excellent computer skills including proficiency in Microsoft Office products.

  • Knowledge of basic human anatomy, physiology, medical terminology.

  • Ability to represent the University and Division of GI in a professional and positive manner

  • Intrinsically motivated and assertive with ideas

  • Flexible and innovative thinker

  • Thrives on the challenges encountered in fluid, complex, high opportunity environments

Job: *Faculty

Organization: *U0001 -- DENVER & ANSCHUTZ MED CAMPUS

Title: Senior Clinical Research Coordinator (Senior PRA)

Location: Aurora

Requisition ID: 17190

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