University of Colorado · 2 months ago
Clinical Research Point Coordinator – Open Rank Intermediate to Senior
Aurora, CO
Full-time
Hybrid
Mid, Senior Level
$53K/yr - $67K/yr
1+ years expThe University of Colorado Anschutz Medical Campus is seeking a Clinical Research Point Coordinator to support various drug, device, and biologic studies. The role involves regulatory compliance, study coordination, and mentoring junior staff while managing independent decision-making and project management responsibilities.
EducationHigher EducationUniversities
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
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 with teams, supervisors and/or leadership in creating and implementing processes and procedures and quality improvement initiatives related to CReST operational efficiency and the coordinator program
Qualification
Required
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
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
Two (2) years of clinical research or related work experience, including experience with FDA-regulated trials and Industry-sponsored trials
ACRP or SoCRA certification (must be obtained within 6 months of date of hire)
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
Benefits
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
Company
University of Colorado
University of Colorado offers higher education and serving as the catalysts in business, arts, health, and community growth.
10001+ employees
H1B Sponsorship
University of Colorado has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (184)
2024 (124)
2023 (163)
2022 (115)
2021 (86)
2020 (95)
Funding
Current Stage
Late StageTotal Funding
$0.5MKey Investors
US Department of EnergyUS Department of Commerce, Economic Development Administation
2023-07-27Grant
2023-01-26Grant
2021-04-06Grant· $0.5M
Leadership Team
Richard Schulick
Professor and Chair of Surgery
Recent News
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2025-12-28
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