Description
University of Colorado | CU Anschutz Medical Campus

School of Medicine, Department of OB/GYN, Division of Academic Specialists

Official Title: Research Services Clinical Science Professional (Open Rank)

Working Title: Clinical Science Professional (Open Rank: Entry-Senior)

Position #00793944– Requisition #24754

* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *

The University of Colorado has a requirement for COVID-19 vaccinations and full completion thereof by 9/1/21 or upon start date.  Information regarding this requirement, and exemptions can be found at:

Anschutz: https://www.ucdenver.edu/docs/librariesprovider284/default-document-library/3000-general-admission/3012---covid-19-vaccination-requirement-and-compliance.pdf?sfvrsn=4e9df3ba_2

Denver: https://www.ucdenver.edu/coronavirus

Exemptions vary by campus location/department.

Campus/Unit-Specific Exemptions:

Anschutz Campus – Accommodations may be granted for medical or religious reasons.Denver Campus - Exemptions are allowed for medical, religious, or personal reasons.Consolidated/Central Services Administration – Accommodations may be granted for medical or religious reasons.

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 University of Colorado Anschutz Medical Campus is a public education, clinical and research facility serving 4,500 students, and a world-class medical destination at the forefront of life-changing science, medicine, and healthcare. CU Anschutz offers more than 42 highly rated degree programs through 6 schools and colleges and receives over $500 million in research awards each year. We are the single largest health professions education provider in Colorado, awarding nearly 1,450 degrees annually. Powered by our award-winning faculty, renowned researchers and a reputation for academic excellence, the CU Anschutz Medical Campus drives innovation from the classroom to the laboratory to the delivery of unparalleled patient care. Read CU Anschutz Quick Facts here.

The School of Medicine’s Department of OB/GYN has an opening for a full-time University Staff (unclassified) Research Services Clinical Science Professional (Open Rank: Entry-Senior) in the Division of Academic Specialists.

Jobs in the Research Services 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.

Professionals at all levels 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.  At the entry level, duties are limited in scope and are performed with guidance and direction from other professionals and are performed in a training and development capacity.

At the intermediate level, duties are less limited in scope and are performed independently with occasional guidance and direction from other professionals. And at the senior level work is performed fully independently.

Nature of Work

Clinical Science Professionals perform clinical research related functions which may include patient-oriented research or research conducted with human subjects. Patient-oriented research includes mechanisms of human disease, therapeutic interventions, clinical trials, or development of new technologies. Clinical Science Professionals may also assist with epidemiologic and behavioral studies and/or outcomes research and health services research. Some Assignments will not move beyond the senior level.

This Clinical Science Professional will be providing support for multiple division investigators and studies.  The position is based at the Anschutz Medical Campus.   While some remote work is possible, the position does require that the candidate be present on campus as needed.  This is a position requiring an enthusiasm for research and knowledge or interest in women’s health.  The candidate will be self-directed, detail-oriented, and adaptable in a high-intensity research environment.  A solid fundamental knowledge of biological and medical sciences is necessary for this position.  Excellent communications skills, critical thinking, and the ability to independently problem-solve are also required.  It is anticipated that a successful candidate will have strong skills in organization and attention to details. 

Supervision 

The Director of Research in the Division of Academic Specialists in Ob/Gyn supervises this position.

Examples of Duties Performed

Entry Level:

• 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 confirms eligibility of subject to participate in clinical trial
• Perform 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
• Interview prospective subjects for a variety of research clinical trials. Educate potential subjects on the details of the studies through phone contacts and personal interviews
• Schedule subject participation in research clinical trial, coordinating availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy)
• Collect, code, and analyze data obtained from research in an accurate and timely manner
• Obtain study subject’s medical history through chart reviews in the Electronic Medical Record, EPIC

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

Intermediate Level, all the above and:

• 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 Team Leads, Supervisors and/or management with creation and implementation of processes and procedures and quality improvement initiatives
• Act as a Primary Coordinator on multiple trials/studies
• Assist and train junior team members
• Assist with staffing needs (such as working with student workers) in coordination with project investigators

Senior Level, all the above and:

• Assist with developing or develops protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Maintains subject level documentation and prepares documents, equipment and/or supplies
• Assist with identifying issues related to operational efficiency and shares results with leadership
• Collect information to determine feasibility, recruitment and retention strategies. Employ, evaluate and assist with the implementation of innovative solutions to maximize recruitment and retention
• Serve as a resource and participate in study initiation and close out duties

Additional Duties & Responsibilities:

All Levels:

• Develop and submit institutional review board proposals for international and domestic studies
• Independently organize and track study progress for assigned studies
• Assist with and oversee the day-to-day operations of multiple clinical trials and studies
• Assist Primary Investigators with implementation of study processes and procedures and quality improvement initiatives
• Design and maintain Redcap databases for multiple studies
• Conduct literature searches
• Edit manuscripts for journal format requirements and submit manuscripts for publication
• Assist in poster and presentation formatting and design for professional conference presentations
• Various activities related to grant compliance and oversight such as preparing funder progress reports and assisting with budget tracking

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.

Salary and Benefits

The salary range (or hiring range) for this position has been established at:

Entry: $44,403 - 56,481

Intermediate: $48,321 - 61,464

Senior: $52,239 - 66,448

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.The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialty, and training.

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: https://www.cu.edu/employee-services/benefits

Total Compensation Calculator: http://www.cu.edu/node/153125

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 hr.adacoordinator@ucdenver.edu.

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 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.

Qualifications
Minimum Qualifications

Entry Level

Bachelor’s degree in any fieldA combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis

Intermediate Level

Bachelor’s degree in any fieldA combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis

One (1) year clinical research or related experienceSenior Level

Bachelor’s degree in any fieldA combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis

Two (2) years clinical research or related experienceApplicants must meet minimum qualifications at the time of hire.

Preferred Qualifications

All Levels

Bachelor’s degree in science or health related fieldOne (1) to three (3) years of clinical research or related experienceExperience with electronic data capture systems (e.g. EMR or EHR and data management systems)

Competencies, Knowledge, Skills, and Abilities

Knowledge and understanding of federal regulations and Good Clinical Practice (GCP)Ability to communicate effectively, both in writing and orallyAbility to establish and maintain effective working relationships with employees at all levels throughout the institutionOutstanding customer service skillsDemonstrated commitment and leadership ability to advance diversity and inclusionKnowledge of basic human anatomy, physiology medical terminologyAbility to interpret and master complex research protocol information

Job Category: Research Services
Primary Location: Aurora
Schedule: Full-time
Posting Date: May 17, 2022
Unposting Date: Ongoing