University of Colorado - Aurora, CO

posted 19 days ago

Full-time - Entry Level
Aurora, CO
Educational Services

About the position

The Open Rank Clinical Sciences Professional position at the University of Colorado Anschutz Medical Campus involves screening and enrolling patients in clinical and observational studies, primarily focused on asthma exacerbations in children. The role encompasses various responsibilities related to clinical trials, including patient interaction, data collection, and compliance with regulatory standards. This position is available at both entry and intermediate levels, allowing for a range of experience and responsibilities.

Responsibilities

  • Assist with and oversee the day-to-day operations of clinical trials and studies.
  • Obtain study subject's medical history and current medication information, review research protocol inclusion/exclusion criteria, and confirm eligibility of subject to participate in clinical trial.
  • Perform the 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 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 working order.
  • Perform study procedures (e.g. collect nasal swabs and obtain lung function measurements) and review the quality of sample collection.
  • Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies (Intermediate Level Only).
  • Independently perform study-related processes, procedures, and assessments as defined in the study protocol and in compliance with regulating bodies (Intermediate Level Only).
  • Assist Team Leads, Supervisors, and/or management with the creation and implementation of processes and procedures and quality improvement initiatives (Intermediate Level Only).
  • Assist in the coordination of multiple trials/studies (Intermediate Level Only).
  • Assist and train junior team members (Intermediate Level Only).

Requirements

  • Bachelor's degree in any field (Entry Level).
  • Bachelor's degree in any field and one (1) year of clinical research or related experience (Intermediate Level).
  • Knowledge 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, and medical terminology.
  • Ability to interpret and master complex research protocol information.
  • Ability to work with a diverse group of research study participants and staff.
  • Ability to multi-task and handle multiple studies concurrently.
  • Ability to work in an active and stressful environment.
  • Ability to identify patients qualifying for several diverse clinical research studies.
  • Ability and willingness to be present in patient rooms during procedures.
  • Ability to work autonomously, as well as under direct supervision, and to share work duties with other team members.

Nice-to-haves

  • 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).
  • Prior experience performing the Informed Consent process.
  • Bilingual (English/Spanish).
  • Prior experience working in an emergency/outpatient setting.
  • Prior experience interviewing patients or persons under emergency conditions.
  • Prior experience working with children and parents.

Benefits

  • 401(a) retirement plan with employer contributions of 10% of gross pay.
  • Disability insurance.
  • Health insurance with multiple plan options.
  • Dental insurance with multiple plan options.
  • Paid time off including 22 vacation days, 15 sick days, and 10 holidays per year.
  • Tuition benefit for employees on all CU campuses.
  • ECO Pass for reduced rate RTD Bus and light rail service.
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