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CO Research Program Coordinator

Johns Hopkins University
United States, Maryland, Baltimore
May 09, 2024

We are seeking a COResearch Program Coordinator who will be responsible for all aspects of recruitment, enrollment and follow-up of subjects in clinical research studies, as well as preparation and maintenance of all regulatory required submissions. Interacts with study participants over the age of 18, department physicians and staff, Institutional Review Board and Office of Research Administration staff, Institutional Investigational Pharmacy staff, as well as Pharmaceutical Company employees such as Clinical Research Associates and Managers, and others contracted by the Pharmaceutical Company to manage the study.

Specific Duties & Responsibilities

  • Identifies and recruit's eligible subjects that meet all study criteria. Obtains informed consent from subjects prior to initiation of study procedures and maintains patient confidentiality according to HIPAA regulations.
  • Schedules and coordinates study subject visits for study exams. Completes and records required protocol testing during subjects' study visits such as vital signs, ETDRS refraction, distance and near visual acuity, low luminance testing, auto-refractometry, keratometry, applanation tonometry, and administration of visual function questionnaires to subjects.
  • Collects and records required study data from subjects, including complete medical, ophthalmic and medication history. Completes clinical report forms, enters data into sponsor's electronic data capture systems and responds to data edits in an accurate and timely fashion.
  • Processes blood and urine laboratory samples and packages for shipment according to protocol and DOT/IATA requirements.
  • Collects serious adverse event data and reports information to pharmaceutical sponsor and IRB within required timelines. Assists the principal investigator in preparing regulatory submissions required for IRB and sponsor review.
  • Prepare and submit annual continuing review reports.

Minimum Qualifications
  • Bachelor's Degree in related discipline.
  • Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.
  • Prior experience with patient interaction and have familiarity with recruiting patients for a research study.
  • Some working medical knowledge, especially in the field of Ophthalmology.
  • Must obtain Certified Ophthalmic Asst (COA) from JCAHPO within 18 months of start date.

Preferred Qualifications
  • Three years related experience/ masters Degree.
  • Prior research experience is preferred; must be comfortable working with databases, spreadsheets, and medical records.

Classified Title: Research Program Coordinator
Job Posting Title (Working Title):CO Research Program Coordinator
Role/Level/Range: ACRO40/E/03/CD
Starting Salary Range: $17.00 - $30.00 HRLY ($55,640 targeted; Commensurate with experience)
Employee group: Full Time
Schedule: Monday-Friday, 8:30 am - 5:00pm
Exempt Status:Non-Exempt
Location:Hybrid/School of Medicine Campus
Department name: SOM Oph Retina Service
Personnel area: School of Medicine