Clinical Research Point Coordinator – Open Rank Intermediate to Senior

The University of Colorado’s Clinical Research Support Team seeks a Clinical Research Point Coordinator to provide regulatory, study coordination, and data collection and entry support for drug, device, and biologic studies. The role may lead study coordination, manage startup and regulatory activities, and train and guide junior coordinators, with senior-level responsibilities including advising investigators and project-managing study startup.

Responsibilities

• Shepherds and completes study startup activities from initial site selection through budget negotiation, operationalization, organizational and regulatory approvals, and site activation to prepare completely for enrollment of the first study subject
• Proactively seeks guidance and engages stakeholders to problem solve and push forward startup activities efficiently to meet sponsor timelines
• Delegates startup tasks to other assigned team members and/or leadership to efficiently execute and meet timelines and milestones
• Independently crafts and submits nursing orders for approval
• Modifies, or supervises modifications of Informed Consent Forms to comply with Institutional guidelines and obtains required approvals
• Completes and manages regulatory submissions to local and central IRBs, PRMS, and other regulatory bodies. Drafts regulatory documents and completes forms/paperwork. Fields questions and provides study-specific updates related to regulatory submissions and progress
• Trains and mentors junior staff, and serves as a reference point within CReST for questions and guidance related to their duties and assigned studies
• Develops protocol-specific systems and documents including process flows, training manuals, source documents, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs)
• Demonstrates and applies comprehensive working knowledge of applicable regulations, policies and GCP, and advises coworkers and study teams on compliance and application
• Assists senior staff with more advanced tasks
• Provides feedback to CReST managers and leadership on billing and invoicing systems and related metrics
• All entry and mid-level duties
• Advises investigators on regulatory matters, best practices, and institutional policies. May develop or assist with development of research plans
• Engages with essential research resource teams on campus, including UCHealth Research Admin, OnCore, pharmacies, labs, and clinics for study planning. Develops working relationships with key contacts to strategize on study startup and implementation
• Independently project-manages full-service study startup. Negotiates Study Startup Agreements
• May present on behalf of CReST or studies at University or external events
• Oversees study closeout and archiving activities
• Serves as a strategic partner and advisor to CReST leadership on development and implementation of SOPs and other standard work
• Consult as needed with CReST leadership on the activities, status, metrics, and capabilities of the CReST coordinator program
• Undertakes special projects in collaboration withteams, supervisors and/or leadership in creating and implementing processes and procedures and quality improvement initiatives related to CReST operational efficiency and the coordinator program

Preferred

• Previous experience with software programs such as REDCap, OnCore and EPIC are preferred
• Experience with University of Colorado Anschutz and/or affiliated Hospital (e.g., UCHealth, CHCO) policies and procedures is preferred
• Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)
• Experience with study startup and implementation
• Clinical research drug and/or device study coordination experience
• Lab and sample collection and processing experience
• Research training: CITI, GCP, IATA, blood borne pathogens, Basic Life Support (BLS)
• Experience completing routine clinical research tasks and documentation, such as conducting informed consent or assessing eligibility
• Experience with NIH grant-funded research
• Experience with study startup and/or feasibility assessment
• ACRP or SoCRA certification (must be obtained within 6 months of date of hire)
• REDCap
• OnCore
• EPIC
• University of Colorado Anschutz Policies
• UCHealth Policies
• CHCO Policies
• Electronic Data Capture Systems
• EMR/EHR Systems
• Data Management Systems
• Study Startup
• Study Implementation
• Feasibility Assessment
• Clinical Research Coordination
• Drug Study Coordination
• Device Study Coordination
• Lab Sample Collection
• Sample Processing
• CITI Training
• Clinical Practice (GCP)
• IATA Training
• Bloodborne Pathogens Training
• Basic Life Support (BLS)
• Clinical Research Documentation
• Informed Consent
• Eligibility Assessment
• NIH Grant-Funded Research
• ACRP Certification
• SoCRA Certification

Benefits

• Hybrid schedule of 4 days per week on campus and as needed for in-person meetings
• Medical: Multiple plan options
• Dental: Multiple plan options
• Additional Insurance: Disability, Life, Vision
• Retirement 401(a) Plan: Employer contributes 10% of your gross pay
• Paid Time Off: Accruals over the year
• Vacation Days: 22/year (maximum accrual 352 hours)
• Sick Days: 15/year (unlimited maximum accrual)
• Holiday Days: 10/year
• Tuition Benefit: Employees have access to this benefit on all CU campuses
• ECO Pass: Reduced rate RTD Bus and light rail service
• May be eligible for overtime compensation, depending on the level

Company

• Public research university with four Colorado campuses
• Denver, Colorado, USA
• https://www.cu.edu/
• Founded in 1876
• 10001+ employees

Qualifications

• A bachelor's 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 and 1 year of professional level experience working in human subjects' research
• A bachelor's 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
• One (1) year of clinical research or related work experience, including experience with interventional trials
• Two (2) years of clinical research or related work experience, including experience with + FDA-regulated trials + Industry-sponsored trials
• A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis
• Demonstrated tenacity and initiative in proactively problem solving
• Ability to interpret and master complex research protocol information
• Respect for patient rights and dedication to patient safety and protections; excellent patient rapport
• Empathetic to patients with chronic illnesses
• Great attention to detail and quality
• Ability to work with colleagues and patients in a confidential and professional manner
• Ability to follow and execute a study protocol and proactively prevent deviations
• Ability to follow direction of the PI and direct supervisor, follow all department SOPs and department policies
• Critical thinking and sound judgement
• Outstanding organizational and time management skills
• 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 skills
• Demonstrated commitment and leadership ability to advance diversity and inclusion
• Previous experience with software programs such as REDCap, OnCore and EPIC are preferred
• Experience with University of Colorado Anschutz and/or affiliated Hospital (e.g., UCHealth, CHCO) policies and procedures is preferred
• Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)
• Experience with study startup and implementation
• Clinical research drug and/or device study coordination experience
• Lab and sample collection and processing experience
• Research training: CITI, GCP, IATA, blood borne pathogens, Basic Life Support (BLS)
• Experience completing routine clinical research tasks and documentation, such as conducting informed consent or assessing eligibility
• Experience with NIH grant-funded research
• Experience with study startup and/or feasibility assessment
• ACRP or SoCRA certification (must be obtained within 6 months of date of hire)
• A bachelor’s 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 and 1 year of professional level experience working in human subjects’ research.
• A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis.

Required skills

• ACRP Certification, Clinical Research, EPIC, FDA-Regulated Trials, Industry-Sponsored Trials, Interventional Trials, OnCore, REDCap, SoCRA Certification, Study Startup and Implementation

Preferred skills

• Experience with NIH grant-funded research, Experience with study startup and implementation, Experience with study startup and/or feasibility assessment, Lab and sample collection and processing experience

Experience

• 1-2 years