Research Services Clinical Sciences Professional, Intermediate to Senior

The University of Colorado is hiring a Research Services Clinical Sciences Professional for its Department of Obstetrics and Gynecology. The role coordinates and manages clinical trials focused on women’s health, pregnancy, and neonates as part of the Perinatal Research Core.

Responsibilities

• Assist with and oversee the day-to-day operations of OB-GYN and Pediatric clinical trials and studies
• Participate in subject recruitment efforts, including communicating with patients expressing an interest and all pre-screening/screening activities
• 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
• 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
• Schedule subject participation in research clinical trial, coordinating availability of necessary space, and clinical research support (e.g., physician, laboratory, radiology, pharmacy)
• Coordinate and administer patient care in compliance with protocol requirements
• Assist with the development of 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

Preferred

• Bachelor's degree in science or health related field
• Two (2) years of clinical research or related experience
• Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)
• Phlebotomy Certification
• Fluent in Spanish and able to pass a medical interpreter exam
• One years' experience using REDCap or equivalent to build and manage multiple projects
• Experience working in women's health
• One years’ experience using REDCap or equivalent to build and manage multiple projects
• Science
• health degree
• Clinical research
• Electronic data capture
• EMR/EHR systems
• Data management systems
• Phlebotomy certification
• Spanish fluency
• Medical interpretation
• REDCap
• Project building
• Women’s health experience

Benefits

• 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: 15/year
• Tuition Benefit: Employees have access to this benefit on all CU campuses
• ECO Pass: Reduced rate RTD Bus and light rail service

Company

• Public research university with four Colorado campuses
• Denver, Colorado, USA
• https://www.cu.edu/
• Founded in 1876
• 10001+ employees

Qualifications

• Bachelor's degree in education, psychology, business, public administration, health care, educational technology, social science, liberal arts, communications, accounting, finance, library science, or a directly related field from an accredited institution
• One (1) year of clinical research or related experience
• A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor's degree on a year for year basis
• 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
• Two (2) years of clinical research or related experience
• Applicants must be legally authorized to work in the United States without requiring sponsorship. We are unable to provide work visa sponsorship or employment authorization for this position now or in the future
• Knowledge and understanding of federal regulations and Good Clinical Practice (GCP)
• 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
• Knowledge of basic human anatomy, physiology medical terminology
• Ability to interpret and master complex research protocol information
• Bachelor's degree in science or health related field
• Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)
• Phlebotomy Certification
• Fluent in Spanish and able to pass a medical interpreter exam
• One years' experience using REDCap or equivalent to build and manage multiple projects
• Experience working in women's health
• A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year for year basis.

Required skills

• Clinical Research, Clinical Research Protocols, Federal Regulations, Human Anatomy, Phlebotomy, Physiology, REDCap, Spanish, Women’s Health

Preferred skills

• Bachelor's degree in science or health related field, Experience working in women's health, Phlebotomy Certification

Experience

• 1-2 years