Job Description

Job Description

Job Description

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Reports to: Clinical Research Manager Department: Research

Job Type: Full-Time FLSA Status: Non-Exempt

Location:  Colorado Springs Revised: February 13, 2024

General Purpose

The research assistant is primarily responsible for assisting in research patient visits according to ICH-GCP
guidelines and according to the IRB-approved study protocol and/or manual of procedures. Day-to-day
activities may include all or some of the essential functions listed below, depending upon individual
experience / knowledge and the needs of the organization which are subject to change from time to time. Works under close and direct supervision.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Essential Duties/Responsibilities

• Coordinate and schedule subject visits within study/subject specific windows per protocol
  guidelines.
  • Prepare visit-specific documentation and charts for Clinical Research Coordinator
  • Observe Coordinator in patient care and management
  • Assist Coordinator in monitoring subject flow and assist in subject care and management
  • Observe, assist, collect and record all necessary data for follow up (e.g. adverse events, concomitant
  medications, etc.) study visits (Phase 2 & 3; NO Gene Therapy)
  • Transcribe subject study information from source documents to the Electronic Case Report Forms
  • Administer all mandatory questionnaires to study subjects
  • Set up, prepare subject, and conduct electrocardiograms (ECG) on subjects as required per study
  protocol
  • Promptly request all necessary medical records for Serious Adverse Event Reporting
  • Process and ship laboratory biological samples for analysis
  • Perform intraocular pressure checks after injections
  • Perform trial frame refraction and ETDRS visual acuity testing (For ISTs only, at selected sites)
  • Inform subjects and obtain written re-consents in regard to ICF’s
  • Perform other duties as assigned
  • Obtain any applicable additional/required sponsor training and/or certifications

Other Duties/Responsibilities

• An employee in this position may be called upon to do any or all of the following essential functions. These examples do not include all of the functions which the employee may be expected to perform.

Supervisory Duties (if any)

• None

Job Qualifications

Experience / Knowledge / Skills:

• Effective oral and written communication 
• Delivers safe and appropriate care to patients in addition to the requirements outlined by
study protocols 

Education or Formal Training :

• High School diploma or the equivalent, with significant relevant experience
• College degree preferred
• Ophthalmic experience preferred

Working Conditions and Other Conditions of Employment

Working Environment :

This job operates in a fast paced, professional office environment and routinely required the use of standard office equipment such as computers, phones, and photocopiers. Most of the offices are open and modular in layout. Work may involve moderate exposure to ambient or loud noises. In the health center environment, there is potential for contact with blood-borne pathogens and communicable diseases, as well as potential for contact with dissatisfied or abusive individuals. There could be interaction with persons who are mentally ill, disabled, elderly and emotionally upset.

Physical Activities :

These are representative of those which must be met to successfully perform the essential functions of this job.

This is a largely sedentary role but can involve standing or sitting for extended periods of time, bending at the waste, and using hands and fingers to handle and file papers or operate assigned equipment. While performing the duties of this job, the employee is regularly required to talk or hear. Specific vision abilities required by this job include close vision, distance vision, color vision, and ability to adjust focus. Employee may also have to lift 10 to 25 lbs. unassisted.

Other Conditions of Employment:

• Willingness to submit to mandatory random drug screening.
• Willingness to accept temporary assignments and ability to drive to and from other office locations.
• Reimbursement for mileage will be made at the current IRS rates.

Note: This job description is not intended to be an exhaustive list of all duties, responsibilities, or qualifications associated with the job.

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