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University of Colorado Anschutz Medical Campus

Department: Clinical Research Support Team (CReST) - OVCR

Job Title: Clinical Research Startup Specialist

Position #: 00849213 - Requisition #: 40107

Job Summary:

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 Clinical Research Startup Specialist to provide regulatory and operationalization startup support for a variety of interventional and observational studies conducted at the University of Colorado Anschutz Medical Campus and affiliate hospitals, including FDA regulated trials with industry, federal, and non-profit funding.

This position will have independent decision making and project management responsibilities and will consult with CReST leadership on the CReST program's study startup activities, status, metrics, and capacity. Knowledge of Good Clinical Practice, applicable regulations, and of the clinical trial lifecycle 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 operationalization.

Key Responsibilities:

Startup (70%)

• Under the supervision of the Startup Manager, completes study startup projects and activities for multiple simultaneous human subjects research studies.

• Facilitates startup tasks from initial site selection through budget negotiation, operationalization, organizational and regulatory approvals, and site activation.

• Acts as primary contact and/or liaison for study startup between investigators, sponsor representatives, and study staff/coordinators.

• Relays timely information to and between appropriate stakeholders.

• Drafts regulatory documents and completes forms/paperwork.

• Collaborates with study coordination team and campus resources to develop source and essential documents (e.g., ICFs, CRFs, nursing orders, treatment plans, etc.)

• Ensures completion of ISF prior to study activation.

• Schedules and facilitates Pre-Site Selection Visits and Site Initiation Visits, and internal meetings related to site activation.

• Tracks startup progress and collaborates with CReST leadership on study startup metrics reporting and timelines to support efficiency and continuous improvement efforts.

• Shepherds startup projects to completion, exercising independent critical thinking and problem solving and engaging key collaborators to ensure the successful and efficient initiation of studies supported by CReST. This may include designing new pathways or procedures to operationalize complex protocols.

• Under the direction of the Startup Manager, assists with developing clinical trial budgets and identifying pricing for various procedures.

• Facilitates new study intake and services agreement development for applicable CReST request.

• Develops or assists with developing standard operating procedures (SOPs) and Work Instructions for startup-related tasks.

Regulatory & Coordination (20%)

• Acts as a backup study coordinator for CReST protocols during slow startup times or busy coordination times. This effort will fluctuate depending on bandwidth.

• Completes and manages regulatory submissions to local and central IRBs, FDA, and other regulatory agencies for ongoing CReST studies, as needed.

• Assists study coordinators with complex protocol amendments including changes to schedule of events.

• 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.)

Other (10%)

• Accurately tracks billable time by study, targeting an average of ~25 billable hours per week across all studies.

• Assists with team or institutional process improvement or educational initiatives related to startup.

• Provides excellent customer service to both internal and external stakeholders, presenting a positive image of the department and University.

• Other duties, as assigned by manager.

This description is a summary only and describes 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.

Work Location:

Onsite - this role is expected to work onsite and is located in Aurora, Colorado.

Why Join Us:

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.

Why work for the University?

We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:

• 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

There are many additional perks & programs with the CU Advantage.

Qualifications:

Minimum Qualifications:

• Bachelor's degree from an accredited institution and 1 year of professional experience

• 2 years of experience working in research related to human health (e.g., coordination, data analysis, or regulatory)

• Prior experience with study startup, including startup for industry-sponsored clinical trials

• ACRP or SOCRA certification (must be obtained within 6 months of hire)

  • Substitution: A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor's degree on a year for year basis.

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• Prior experience starting and operationalizing clinical trials at University of Colorado Anschutz strongly preferred

• Clinical research drug and/or device study coordination experience

• Experience with Epic (UCH electronic medical record system) and CTMS systems (Oncore)

• Research training: CITI, GCP, IATA, blood borne pathogens, Basic Life Support (BLS)

• Project management experience

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 skills.

• Tenacious problem-solving abilities are absolutely critical to this role

• Proficiency with standard office tools, particularly Excel and Smartsheet

• Knowledge and understanding of federal regulations and Good Clinical Practice (GCP)

• Ability to interpret and master complex research protocol information

• Respect for patient rights and dedication to patient safety and protections

• Great attention to detail and quality

• Critical thinking and sound judgement

• Outstanding organizational and time management skills

Conditions of Employment:

• ACRP or SOCRA certification (must be obtained within 6 months of hire)

How to Apply:

For full consideration, please submit the following document(s):

1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position (only use if a cover letter is necessary)

2. Curriculum vitae / Resume

3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address

Questions should be directed to: Erin McDonagh Erin.McDonagh@cuanschutz.edu

Screening of Applications Begins:

Immediately and continues until the position has been filled.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as  $58,705 - $78,665

The above salary range (or hiring range) represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level.

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.

Total Compensation Calculator

Equal Employment Opportunity Statement:

CU is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing nondiscrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply, including protected veterans and individuals with disabilities.

ADA Statement:

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 hr.adacoordinator@cuanschutz.edu.

Background Check Statement:

The University of Colorado 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.

Vaccination Statement:

CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.