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We are seeking a Sr.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. Trains and manages other study coordinator team members.
Identifies, recruits and screens all eligible subjects that meet study enrollment criteria. Obtains informed consent from subjects prior to initiation of study procedures and maintains patient confidentiality according to HIPAA regulations. 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. Submits ocular images (OCT/FA/FP/FAF) and ECG results electronically to study reading centers. 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 and query resolutions, both with and without principal investigator's assistance, in an accurate and timely fashion. Processes blood and urine laboratory samples and packages for shipment according to protocol and DOT/IATA requirements; retrieves laboratory results for investigator review and signature. Schedules and coordinates study subject visits for study exams. Creates and maintains study subject screening, enrollment and terminations within the CRMS system. Responds to queries from the CRMS and JH billing department staff regarding research visits. Collects serious adverse event data and reports information to pharmaceutical sponsor and IRB within required timelines. Assists the principal investigator in preparing regulatory submissions, including IRB new, change in research, continuing review and termination reports, as well as IND safety reporting, and responds to IRB queries on applications as warranted.
Coordinates community outreach for and awareness of clinical trials by giving presentations at local retirement communities, and arranges sponsor funded and IRB approved advertising through local news outlets and social media, loco regional private ophthalmic practices, as well as through collaborations with the Johns Hopkins Communications and Marketing Department. Creates advertisement submissions for approval on the JH ICTR Trials@Hopkins website.
Trains and manages other study coordinators/team members in all aspects of the previously listed coordinator responsibilities. Trains and prepares new research coordinator team members in protocol refraction and distance, near and low luminance visual acuity measurement, for examination and certification by external certification agencies. Looking forward, has been tasked with creating standard operating procedures for regular competency assessment of team members protocol refraction and visual acuity measurement skills. Will also create SOP for regular internal audits for quality assurance of protocol adherence, accurate study data collection and electronic data capture, data query management and timely filing of study regulatory submissions.
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.
Trains and manages other study coordinator team members in all aspects of the previously listed coordinator responsibilities.
Coordinates community outreach and advertising for clinical trials by giving presentations to local retirement communities and arranging sponsor funded and IRB approved advertising through local news outlets, as well as through collaborations with the Johns Hopkins Communications and Marketing Department.
Bachelor's Degree in related discipline.
Three years related experience.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
Licensure, Certification, Registration
Certified Ophthalmic Assistant through the Joint Commission of Allied Health Personnel in Ophthalmology.
CPR (AHA Healthcare Provider) certified.
Special Knowledge, Skills, & Abilities
ETDRS protocol refracting, near and distance visual acuity testing, low luminance testing, auto-refraction and keratometry, ocular coherence tomography and administration of visual functioning questionnaires.
Blood and urine lab sample processing and packaging in compliance with protocol and DOT/IATA requirements.
Knowledge of FDA Code of Federal Regulations Good Clinical Practice requirements of conducting pharmaceutical clinical research trials.
Competent in Johns Hopkins electronic Institutional Review Board application process, CRMS and EPIC electronic medical records system.
Certified to use multiple electronic data capture systems preferred by most clinical trial sponsors (iMedidata, iMedNet, Medrio)
Classified Title: Sr. Research Program Coordinator Role/Level/Range: ACRP/03/MB Starting Salary Range: $40,100-$55,140-$70,180 Annually (Commensurate with experience) Employee group: Full Time Schedule: Monday-Friday, 8:30 - 5:00 Exempt Status: 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.
The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the Talent Acquisition Office at email@example.com. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit accessibility.jhu.edu.
The following additional provisions may apply, depending on campus. Your recruiter will advise accordingly.
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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Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to learn but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130 years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses throughout the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are based at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Bal...timore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.
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