We are seeking a Research 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 recruits 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
Bachelor's Degree in related discipline.
Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.
Three years related experience.
Prior experience with patient interaction and have familiarity with recruiting patients for a research study.
Working medical knowledge, especially in the field of Ophthalmology.
Prior research experience.
Comfortable working with databases, spreadsheets, and medical records.
Licensure, Certification, Registration: Certified Ophthalmic Assistant through the Joint Commission of Allied Health Personnel in Ophthalmology. Must obtain Certified Ophthalmic Assistant (COA) from Joint Commission on Allied Health Personnel in Ophthalmology (JCAHPO) within 18 months of start date. Must maintain certification while employed at Wilmer.
Classified Title: Resesarch Program Coordinator Role/Level/Range: ACRO40/E/03/CD Starting Salary Range: $16.75-$23.00-$29.30 HRLY (Commensurate with experience) Employee group: Full Time Schedule: Monday-Friday, 8:30 - 5:00 Exempt Status: Non-Exempt Location: School of Medicine Campus Department name: SOM Oph Retina Service Personnel area: School of Medicine
Total Rewards The referenced salary range is based on Johns Hopkins University's good faith belief at the time of posting. Actual compensation may vary based on factors such as geographic location, work experience, market conditions, education/training and skill level. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines:
JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.
**Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.
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The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
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