Clinical Research Senior Coordinator - Aurora, United States - University of Colorado

Description

University of Colorado | CU Anschutz Medical Campus

Clinical Research Support Team (CReST) - OVCR

Job Title Clinical Research Senior Coordinator

Position # Requisition #28335

The University of Colorado 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 Clinical Research Support Team has an opening for a full-time University Staff (unclassified) Senior Clinical Research Coordinator position.

The University of Colorado Anschutz Medical Campus is a world-class medical destination at the forefront of transformative science, medicine, education and patient care.

The campus encompasses the University of Colorado health professional schools, more than 60 centers and institutes, and two nationally ranked independent hospitals - UCHealth University of Colorado Hospital and Children's Hospital Colorado - that treat more than two million adult and pediatric patients each year.

Innovative, interconnected and highly collaborative, the University of Colorado Anschutz Medical Campus delivers life-changing treatments, patient care and professional training and conducts world-renowned research fueled by over $650 million in research grants.

For more information, visit

This description is a summary only and is describing the general level of work being performed, it is not intended to be all-inclusive.

The duties of this position may change from time to time and/or based on business need.

We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.

Jobs in this career family provide direct professional support of research activities.

Functions include contracts and grants solicitation and administration, grant/agreement preparation, review and negotiation, regulatory compliance, sponsor communication and post and pre award management, human subject compliance, research animal management, research laboratory coordination and instruction, environmental health and safety, radiation control, hazardous materials use, disposal and training.

Senior Professionals are responsible for exercising discretion, analytical skill, personal accountability and responsibility in a wide range of areas including academic, administrative, managerial and student services functions.

Work involves creating, integrating, applying and sharing knowledge directly related to a professional field. Work is performed fully independently.


Position Emphasis:
The Clinical Research Support Team (CReST) is part of Office of the Vice Chancellor of Research (OVCR).

CReST provides a la carte support services to clinical investigators for all activities related to the successful conduct of clinical research, from study start-up through close out.

This is the cornerstone to translate basic science knowledge into clinically useful treatment for patients.

The Clinical Research Support Team (CReST) has an opening for a full-time 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 and will consult as needed with CReST leadership on the activities, status, metrics, and capabilities of the CReST coordinator program.

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.

Examples of Duties Performed

• Acts as primary contact and/or liaison for investigators, sponsor representatives, and study subjects for assigned research studies. Relays timely information to and between appropriate stakeholders.
• Trains and mentors intermediate and entry level coordinators and serves as a reference point within CReST for questions and guidance related to their duties and assigned studies.
• Independently performs study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies This position involves frequent, comprehensive direct patient contact. A high level or ethics and integrity is essential to protecting the rights and welfare of subjects and ensuring satisfactory clinical trial conduct.
• Coordinates and conducts clinical research visits with potential and enrolled study participants.
• Recruits prospective subjects for a variety of research clinical trials. Educates potential subjects on the details of the studies through phone contacts and personal interviews
• Reviews 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
• Manages scheduling of participants, tracks subject participation, and participates in monitoring visits
• Ensures that the necessary supplies and equipment for studies are in stock and in working order
• Oversees lab activities, such as basic processing technique (e.g., centrifuge, aliquot serum, blood slides, etc.) and/or transporting blood specimens to the lab, and shipping and tracking laboratory samples
• Accurately enters source data into Case Report Form (CRF) or study database in a timely manner. Reviews records after each visit for completeness and accuracy. Maintains participant research files. Reviews and resolves database queries
• Recognizes adverse events and serious events and promptly notifies appropriate parties, allowing for compliance with applicable reporting timelines
• Independently masters study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies
• Actively participates in site initiation, closeout, and other ongoing and individual research team meetings. Serve as a resource and participate in study initiation and close out duties
• Assures compliance with applicable regulations (FDA; OHRP, etc.), external and internal policies (NIH; CU and hospital affiliates, IRBs, etc.) departmental Standard Operating Procedures (SOPs), and research standards and best practices (ICH Good Clinical Practice (GCP), and Good Documentation Practices (GDP), etc.)
• Assembles and maintains study-specific regulatory binders
• Completes and manages regulatory submissions to local and central IRBs, FDA, and other regulatory agencies. Drafts regulatory documents and completes forms/paperwork. Fields questions and provides study-specific updates related to regulatory submissions and progress
• Assists with developing or develops protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs)
• Assesses and determines appropriate assignments based on team bandwidth and expertise. Collaborates with CReST colleagues to ensure appropriate study coverage and backup
• 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
• Accurately tracks billable time by study. Provides feedback to CReST managers and leadership on billing and invoicing systems and related metrics
• Provides excellent customer service to both internal and external stakeholders by presenting a positive image of the department and University
• Exercises independent critical thinking and decision making to ensure the successful conduct of assigned studies and of the CReST coordinator program
• Other duties, as assigned

This description is a summary only and is describing the general level of work being performed, it is not intended to be all-inclusive.

The duties of this position may change from time to time and/or based on business need.

We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.

Minimum 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 2 years of professional level experience working in human subjects' research.
• Prior experience with direct patient contact
• Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.

Required:
Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications

• Three (3) years of clinical research or related experience
• Prior experience with direct patient contact
• Experience with electronic data capture systems (e.g., EMR or EHR and data management systems)
• 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
• ACRP or SOCRA certification
• Experience with Epic (UCH electronic medical record system) and CTMS systems (Oncore)
• Experience with RedCap, eCRF databases
• Project management skills
• Basic statistical skills
• Experience administering questionnaires or assessments (e.g., cognitive assessments)
• Bilingual (Spanish & English)

Competencies

• 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

Additional Competencies

• Knowledge and understanding of federal regulations and Good Clinical Practice (GCP)
• Knowledge and familiarity with clinical research study conduct
• 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
• Project management skills

PLEASE NOTE:
Candidates will be responsible for travel expenses related to the interview process and any relocation expenses, if applicable.

Salary and Benefits

The salary range (or hiring range) for this position has been established at $52,239 to $62,000.

This position is not eligible for overtime compensation.

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:

Total Compensation Calculator:
Diversity and Equity

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at

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, persons within the LGBTQ community, and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

The 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 investigations for all prospective employees.