The Department of Genetic Medicine is seeking a Research Program Coordinator who will be responsible for coordinating clinical research activities, including data management, maintaining IRB documents and carrying out day to day activities of clinical research projects at the Johns Hopkins University Greenberg Center for Skeletal Dysplasia. This individual will have a variety of support tasks including: preparing paperwork and record reviews for study visits, communicating with study participants to address questions, maintaining study records using study-specific online databases (EPIC, CRMS, RedCap, as well as industry sponsored registries), submitting adverse events reports and scheduling study visits, and several additional tasks vital to the ongoing operations of the study.
The Research Program Coordinator will work with a collaborative multi-disciplinary team to ensure adherence to proper study procedures and ensure the viability of study data. This will include pharmaceutical sponsored research and investigator-initiated research. Responsible for monitoring progress of research protocols and collection of research data on patients entered into research protocols.
Specific Duties and Responsibilities:
Work closely with the Principal Investigator and clinical trials team to ensure smooth and efficient execution of research protocols
Assist with coordinating patient's research visits (i.e., meeting and transporting patients), and consent research participants, collect and record research data, control data quality and maintain research integrity.
Responsible for the organization, entry, maintenance, and accuracy of all patient clinical research data in a timely and ongoing manner.
Prepare necessary paperwork packets for study visits.
Perform record reviews, using the EPIC system, and uploading the relevant materials into the online study databases.
Prepare new IRB protocols, annual renewal requests, and amendments with clinical input according to IRB for submission by the Principal Investigator.
Complete and maintain the appropriate HIPAA and Human Subjects Certifications.
Administer questionnaires to study participants.
Coordinate with the study staff of related clinical studies.
Report to the Principal Investigator weekly for updated list of tasks.
Recruit study participants from a clinical setting.
Perform the informed consent process with potential study participants.
Enter data into standardized computer programs including specially designed web-based programs as well as EXCEL and ACCESS databases.
Maintain good working knowledge of all assigned protocols, maintain regulatory binder for each assigned protocol, verifies patient eligibility for studies, and meet regularly with principal investigators and supervisor of studies for review data accuracy and overall progress.
Assist in coordinating serious adverse event reporting with clinicians and investigators to insure prompt reporting to JHM IRBs and study sponsor.
Perform miscellaneous related duties as assigned.
Bachelor’s degree in related discipline with some related experience required. Additional education may substitute for required experience and additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.
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.
Additional Knowledge, Skills, and Abilities:
Ability to work in MS Excel, MS Access, and MS Word required. Attention to detail required, as well as the ability to work independently. Excellent verbal and written communication skills.
Any specific physical requirements for the job:Sitting in a normal seated position for extended periods of time. Reaching by extending hand(s) or arm(s) in any direction. Finger dexterity to manipulate objects with fingers rather than with whole hand or arm, for example, using a keyboard. Ability to move about workspace.
Classified Title: Research Program Coordinator Role/Level/Range: ACRO40/E/03/CD Starting Salary Range: $16.26 - $22.35/Hour; Commensurate with experience Employee Group: Full Time Schedule: Monday - Friday, 8:30am - 5:00pm Exempt Status: Non-Exempt Location: School of Medicine, East Baltimore Campus Department Name: Genetic Medicine, Greenberg Center for Skeletal Dysplasia Personnel Area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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