Clinical Research Point Coordinator – Open Rank Intermediate to Senior

University of Colorado•Hybrid, CO

2d•$52,721 - $72,498•Hybrid

About The Position

The Clinical Research Support Team (CReST) has an opening for a full-time Point to Senior Clinical Research Coordinator to provide regulatory, study coordination, and data collection/entry support for a variety of drug, device and biologic studies conducted at the University of Colorado Anschutz Medical Campus and affiliate hospitals. This position may act as lead or co-lead coordinator overseeing coordinating activities for assigned studies, and/or as a primary contact for training and guidance for junior coordinators supporting these studies. This position will have independent decision making and project management responsibilities. Knowledge of Good Clinical Practice and Good Documentation Practices in the context of clinical research is essential. We are seeking an individual who is collaborative, communicative, caring, detail oriented and organized, proactive, able to think critically, focused on quality, passionate about research, dedicated to personal growth, and highly motivated in all areas of study coordination.

Requirements

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.
Applicants must meet minimum qualifications at the time 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
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
Industry-sponsored trials
Experience with study startup and/or feasibility assessment
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.

Nice To Haves

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
ACRP or SoCRA certification (must be obtained within 6 months of date of hire)

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.