Principal Clinical Science Professional

Job Summary:

The Division of Plastic and Reconstructive Surgery is seeking a motivated, passionate and self-driven individual for a full time Principal Clinical Science Professional position to assist faculty and residents with clinical trials research, developing a clinical research program and supervising the clinical research team within the division.

Principal 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. Principal Clinical Science Professionals may also assist with epidemiological and behavioral studies and/or outcomes research and health services research. Principal Clinical Science Professionals either act as work/team leads for 2 or more FTE Professionals, operate as Clinical Research Nurses (RN), or are the subject matter experts (SME) in a particular area. SMEs possess a deep knowledge and oversight of a specific process, function and/or technology. SMEs are considered an authority in the area and are educated on the subject and are also able to share their knowledge with other stakeholders. Some Assignments will not move beyond this level.

Example of Duties Performed

• 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
• 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 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 developing protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs) that meet the requirements of study protocols, and research regulations and best practices (e.g., ICH guidelines, FDA code of Federal Regulations, and Good Clinical Practice (GCP)). Examples of this include proactively preventing deviations, creating source documents, creating backup plans, and ensuring principal investigator oversight.
• 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
• Oversee and provide informal leadership to the team members, including managing day-to-day priorities, evaluating and redistributing workloads on a temporary basis, and mentoring staff
• Provide input and feedback to leadership on team members' overall performance, performance evaluations, opportunities for development, and process improvement initiatives
• Identify training and development opportunities for new and existing team members
• Act as a Subject Matter Expert (SME) and authority in the area(s) of clinical research.

Additional Duties & Responsibilities:

Study Coordination

• Coordinate clinical research visits and collecting/recording data. This position includes comprehensive direct patient contact with a high-level of ethics and integrity.
• Collect information to determine feasibility, recruitment, and retention strategies. Employ, evaluate, and assist with the implementation of innovative solutions to maximize recruitment and retention.
• Assist with IRB submissions for the study protocols.

Data and Database Management

• Review research proposal submission for the division.
• Conduct literature reviews for investigators.
• Collect, code, and analyze data obtained from research in an accurate and timely manner.
• Open and maintain study protocols in OnCore.
• Data entry, survey creation, and organization, and retrieval of data for research projects in REDCap and OnCore.
• Designing and execution of research projects and analysis of data
• Assisting with project planning, data interpretation and team presentations
• Serve as a resource and participate in study initiation and close out duties.

Team Collaboration

• Communicate and collaborate with various colleagues (e.g., principal investigator, clinicians, medical staff, sponsors, contract research organizations (CROs), other research staff, finance and billing professionals, and regulatory team) at various stages of each study assigned. The research services professional is responsible for providing excellent customer service to both internal and external stakeholders by presenting a positive image of the department and University.
• Assist residents, medical students with abstract and manuscript writing.
• Tracking research presentations by faculty, students, and residents at conferences
• Communicate the research findings with the team during meetings when required.

Supervision

• This position would be responsible for the supervision of a research services professional including job responsibilities delegation, annual performance reviews, and leave tracking/approval.

Supervision Received: who does the role report to (job title): Division Administrative Director

Supervision Exercised: who reports to this role (job title and how many): One Research Services Intermediate Professional

Work Location:

Hybrid - this role is eligible for a hybrid schedule of 3 days in-person/2 days remote per week on campus and as needed for in-person meetings in Aurora, CO.

Why Join Us:

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.

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 in science or health related field (Biology or similar field)
• Experience with research database management
• Three (3) years of clinical research or related experience in an academic setting
  
  
  
  • Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year-for-year basis.
  
  
  
  

Preferred Qualifications:

• Bachelor's degree in science or health related field (Biology or similar field)
• Experience with research database management
• Four (4) years of clinical research or related experience in an academic setting
• Supervisory Experience

Competencies: Knowledge, Skills, and Abilities (KSA's):

• Exceptional interpersonal communications
• 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.
• Advanced knowledge and understanding of federal regulations and Good Clinical Practice (GCP)
• Knowledge of basic human anatomy, physiology medical terminology
• Ability to interpret and master complex research protocol information
• (SME) Expert level knowledge of clinical research processes.

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

Questions should be directed to: Jessica Wu (Jessica.2.wu@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 $65,545 - $83,373

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

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.

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.