Clinical Research Startup Specialist - 33101 University Staff

Description

University of Colorado Anschutz Medical Campus

Department: Clinical Research Support Team (CReST) - OVCR

Job Title: Clinical Research Startup Specialist

Position #: 00821154 – Requisition #: 33101

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 drug, device and biologic studies conducted at the University of Colorado Anschutz Medical Campus and affiliate hospitals.

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 coordination.

Key Responsibilities:

Study Startup 45%

Independently manages with minimal supervision study startup projects and activities for multiple simultaneous human subjects research studies.

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

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.

Oversees and verifies completion of delegated startup tasks (e.g., source document creation, ICF edits, regulatory binder assembly, IRB submission, budget development, etc), and advises CReST management on startup needs and performance.

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.

Exercises independent critical thinking and decision making to ensure the successful initiation of studies supported by CReST.

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.)

Customer Service 20%

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.

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

Process Development and Continuous Improvement 15%

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

Establishes relationships with clinic, pharmacy, lab, and hospital stakeholders, and regularly communicates with these entities in order to operationalize complex clinical trials.

Develops standard operating procedures (SOPs) and work instructions for startup-related tasks.

Collaborates with key stakeholders on institutional process improvement initiatives related to startup.

Training and Education: 10%

Develops and presents educational materials to the CReST team and/or CU research community.

Trains and mentors intermediate and entry level coordinators and serves as a reference point within CReST for questions and guidance related to study startup.

Acts as a subject matter expert in startup processes.

Other 10%

Accurately tracks billable time by study, targeting 25 billable hours per week across all studies.

Other duties, as assigned by manager.

Work Location:

Onsite – Work in person with the ability to work remote 1 day a week as work permits

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.

The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off – vacation, sick, and holidays and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness (https://apptrkr.com/get_redirect.php?id=5140477targetURL=https://www.cu.edu/employee-services/benefits-wellness) .

Diversity and Equity:

The University of Colorado 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.

Qualifications:

Minimum Qualifications:

A bachelor's degree in any field

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

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

Preferred Qualifications:

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

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)

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

Project management experience

Experience with electronic data capture systems (e.g., REDCap, RAVE, Advarra EDC, etc.)

How to Apply:

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

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)

Curriculum vitae / Resume

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

Questions should be directed to: Erin McDonagh; [email protected] (https://apptrkr.com/get_redirect.php?id=5140477targetURL=Erin.McDonagh@cuanschutz.edu)

Screening of Applications Begins:

Immediately and continues until position is filled. For best consideration, apply by April 11, 2024.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as $56,169 - $65,717.

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: http://www.cu.edu/node/153125 (https://apptrkr.com/get_redirect.php?id=5140477targetURL=http://www.cu.edu/node/153125)

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 [email protected] (https://apptrkr.com/get_redirect.php?id=5140477targetURL=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 (https://apptrkr.com/get_redirect.php?id=5140477targetURL=https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf) . 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 (https://apptrkr.com/get_redirect.php?id=5140477targetURL=https://research.cuanschutz.edu/ehs/home/divisions/occupational-health/oh-enrollment) .

Qualifications

Application Materials Required: Cover Letter, Resume/CV, List of References

Job Category : Research Services

Primary Location : Aurora Department: U0001 -- Anschutz Med Campus or Denver - 21977 - ADM AVC CReST

Schedule : Full-time

Posting Date : Mar 28, 2024

Unposting Date : Ongoing Posting Contact Name: Erin McDonagh Posting Contact Email: [email protected] (https://apptrkr.com/get_redirect.php?id=5140477targetURL=Erin.McDonagh@cuanschutz.edu) Position Number: 00821154

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The University of Colorado does not discriminate on the basis of race, color, national origin, sex, age, pregnancy, disability, creed, religion, sexual orientation, gender identity, gender expression, veteran status, political affiliation, or political philosophy. All qualified individuals are encouraged to apply.