Clinical Services Professional (Open Rank - Intermediate and Senior Level)

Job Summary:

The Research Services Senior Professional position is designed to work within the Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, to assist with activities required to perform clinical and translational research protocols in the areas of urogynecology. This individual will screen, recruit and enroll subjects in ongoing studies. They will also maintain standard operating procedures, including ensuring Investigational Review Board compliance. Specific duties include: Obtaining medical history and current medications, obtaining and reviewing relevant outside records, reviewing protocol inclusion/exclusion criteria, and confirming eligibility of subject. They will ensure that the informed consent process has occurred, is properly documented, and filed as required. They will familiarize potential subjects with the details of the study through phone contacts and personal interviews and will schedule subject participation in research, coordinate availability of necessary space, and clinical support (including but not limited to physician, clinical staff, and laboratory staff). They will assist in data collection (i.e., discarded specimen obtained during surgeries, blood and urine). Additional tasks include accurate recording of the relevant information on data forms, perform data entry, and data queries. They will coordinate patient follow-up data and scheduling clinic visits. The position will require travel to sites in Aurora (Anschutz medical campus), Lone Tree (Lone Tree Urogynecology Clinic) and Highlands Ranch (Highlands Ranch Hospital). They will serve as the study investigators' primary resource for data management, analysis, and preparation of manuscripts.

Administrative (60%)

• Assist with and oversee the day-to-day operations of clinical trials and studies
• Obtain study subject's medical history and current medication information, reviews research protocol inclusion/exclusion criteria, and confirm eligibility of subject to participate in clinical and translational trials
• Perform informed consent process or ensure that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required
• Interview prospective subjects for a variety of research clinical and translational trials. Educate potential subjects on the details of the studies through phone contacts and personal interviews
• Schedule subject participation in clinical and translational trials, coordinating availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy)
• Adhere to research regulatory standards
• Maintain detailed records of studies to ensure compliance with requirements of the Food and Drug Administration (FDA), study protocols, department, hospital/clinical standard operating procedures and other regulatory guidelines
• Participate in subject recruitment efforts, including communicating with patients expressing an interest and all pre-screening/screening activities
• Ensure that the necessary supplies and equipment for studies are in stock and in working order
• Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies
• Independently perform study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies
• Assist with the coordination and execution of local OB/GYN practice outreach and study education.
• Assist with collection and processing of samples collected for research
• Ensure the maintenance of research folders/checklists, and keep datasheets up to date at each enrollment site
• Maintain study binders, excel follow-up spreadsheets, orientation packet, regulatory binder, etc. for each enrollment site.
• Maintenance of study specific certifications, COMIRB training, computer training and other hospital required training
• Attend and coordinate regular large group and small meetings

Data Analysis (35%)

• Conduct literature search and reviews
• Create/maintain research databases in REDCap, Excel, and OnCore
• Perform statistical analysis on study data and/or collaborate with statisticians-Assist in the preparation of abstracts, posters, and publications
• Submit manuscripts to medical journals
• Assist in the revision of manuscripts to address journal reviewers' comments and critiques
• Collect, code, and analyze data obtained from research in an accurate and timely manner

Other Duties (5%)

• Cover pager on nights, weekends, and holidays to facilitate delivery sample collection

Why Join Us:

The Department of Obstetrics and Gynecology at the University of Colorado is a world-class research enterprise, ranked 17th in the nation by the Blue Ridge Institute for federal funding. The Department currently has an impressive research portfolio of $36M in existing federal and foundation grants and contracts through the lifetime of the projects, increasing in budget annually. Departmental faculty provide a full-spectrum of clinical care for women of all ages, participate in research, and provide education to students and residents.

Our mission is to improve the reproductive health of women through innovative, mechanistic and translational research and through excellence in mentorship of the next generation of reproductive scientists.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.

Equal Employment Opportunity Statement:

The University of Colorado (CU) is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing non-discrimination 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.

Qualifications:

Minimum Qualifications

• Bachelor's degree in any field
• Two (2) years clinical research or related experience

Preferred Qualifications

• Master's degree in science or health related field
• Three to Five years of clinical research or related experience
• Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)
• Biostatistics experience

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
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: Matthew.Bishop@cuanschutz.edu

Screening of Applications Begins:

After Posting

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as

Senior Range: $56,995- $72,498

Intermediate Range: $52,721- $67,061

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.