Clinical Research Point Coordinator

Job Summary:

The Clinical Research Support Team (CReST) has an opening for a full-time Intermediate Clinical Research Point 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.

Key Responsibilities:

Study Coordination - 60%

• 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

CReST Support - 20%

• Under the supervision of CReST leadership and senior coordinators/staff 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.
• Trains and mentors junior coordinators and serves as a reference point within CReST for questions and guidance related to their duties and assigned studies.
• Assists the CReST managers and collaborates with other coordinators in assessing and determining] appropriate assignments based on team bandwidth and expertise. Collaborates with CReST colleagues to ensure appropriate study coverage and backup

Investigator Support - 20%

• Independently masters study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies.
• 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.
• Actively participates in site initiation, closeout, and other ongoing and individual research team meetings. Leads and ensures completion of study initiation and close out duties and tasks.
• 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.). Demonstrates and applies comprehensive working knowledge of applicable regulations, policies and GCP, and advises coworkers and study teams on compliance and application.
• 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.

Work Location:

Hybrid - this role is eligible for a hybrid schedule of 4 days per week on campus and as needed for in-person meetings.

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.

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, ethnically minoritized individuals, persons with disabilities, persons within the LGBTQ+ community and all veterans. In addition, the Anschutz Campus has also been recognized as an Age-Friendly University. The University of Colorado is committed to diversity and equality in education and employment.

Qualifications:

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 1 year of professional level experience working in human subjects' research.
  
  
  
  • A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.
  
  
  
  

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• Prior experience with direct patient contact
• Experiencing managing industry clinical research study startup at CU, including HSR portal and Proposals routing, and budget and calendar review
• Experience creating CTRC orders
• 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

Knowledge, Skills and Abilities:

• 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.

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: John Sorrentino, John.Sorrentino@cuanschutz.edu

Screening of Applications Begins:

Immediately and continues until position is filled.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as $51,956 - $66,088.

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

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.