Under the direct supervision of the Principal Investigator or Research Program Manager, this position will be responsible for the collection of research data on patients entered in Chronic Obstructive Pulmonary Disease Precision Medicine Center of Excellence (COPD PMCOE). The Research Program Coordinator (RPC) will be responsible for participant recruitment, performing clinic visits which include administering questionnaires, spirometry, blood draws, and other biological sample collection, data quality and abstraction of research data.
Specific Duties & Responsibilities:
Determine eligibility of potential participants using EPIC and other electronic databases.
Facilitate obtaining informed consent via MyChart, in-person, or via tablet in clinic setting. Be knowledgeable of the study protocols, including inclusion and exclusion criteria, so that study activities are completed correctly and completely.
Research-related clinical tasks:
Coordinate participant visits and follow-up, track and locate participants. Ensure that proper written informed consent from each study participant is obtained prior to entering study; ensure that the original signed and dated consent from each study participant is filed in participant research record.
Perform data collection, which will include administering questionnaires, blood draws, urine, sputum collection, spirometry and other breathing and functional tests, as needed.
Perform routine tests in a research laboratory, help with organization, storage and shipping of biological samples if necessary
Research-related administrative tasks:
Design and maintain databases, internal tracking sheets and other organizational tools to conduct current and future studies accurately and in compliance with good research practice.
Maintain participant follow-up tracking database; maintain records of study participant status by using an enrollment log (if available REDCap platform will be the system to collect research data, to check data quality and to track participant’s visits).
Trackand assessqualityandcompleteness of dataentry and abstraction;immediatelyraisepotentialconcernswith project manager/study PI.
Document and report progress of research projects.
Schedule, organize and participate in weekly meetings of current research projects to report progress and resolve problems, taking notes, minutes and preparing agenda for next meetings.
Assist the research manager/supervisor in tasks related to IRB submissions: change in research, completing progress reports, tracking of renewal dates, completing adverse event forms, writing draft of new forms/surveys.
Review and assess new protocols for clarity, thoroughness, logistical feasibility, and subject safety. List and clarify concerns and questions about new protocols with PI and/or sponsor.
Prepare for and participate in study audits. Correct errors in database when necessary. Write responses to audit reports with input from the Principal Investigator.
Prepare space for study-related equipment and supplies.
Ensure insurance clearance requests are submitted and appropriate staff members are aware of insurance denials and follows up on status of appeals, etc.
Coordinate with clinical trial financial management staff to identify procedures, laboratory tests and protocol events that require invoicing to the Sponsor as defined in the financial contract. Submit invoices to sponsor
Is knowledgeable of and complies with Good Clinical Practices, ICH guidelines, sponsor guidelines, University and IRB policies. May instruct introductory level clinical research personnel in these guidelines and policies.
Work independently and under the direction of the Research Program Manager to ensure successful completion of each clinical research study.
Serves as the primary point of contact and liaison between PI, research assistants, Lab Coordinator, sponsor and budget office & Office of Research Administration at JHMI.
Maintain detailed working knowledge of all assigned protocols.
Scope of Responsibility:
Knows the informal policies, procedures and practices necessary to conduct the normal function of a specific section, unit, or work area. Is aware of the role of the position and its potential impact on the working unit.
Carries out duties and responsibilities with limited supervision, but asks for clarification when needed regarding data quality and integrity issues and promptly notifies supervisors of any potential concerns regarding interactions with patients.
Requires bachelor’s degree, and some experience. Additional experience may substitute for some education, to the extent permitted by the JHU equivalency formula.
Must have current CPR certification.
Knowledge of clinical research practices and principles required.
Minimum of 3 years' experience in clinical research with a strong background in recruiting participants and pulmonary assessments helpful.
JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. 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.
Certified Medical Assistant;
Experience using SAP, REDCap, OpenSpecimen.
Special Knowledge, Skills, and Abilities:
Position requires flexibility.
Ability to work independently and manage multiple tasks, detail oriented, self-motivated, strong interpersonal skills, ability to use personal computer
Proficiency in Microsoft Word and Excel
Database and spreadsheet knowledge.
Excellent organizational and time management skills required.
Previous experience conducting clinical trial, preferably in hospital setting.
Excellent verbal and written communication skills and interviewing techniques required.
Technical Qualifications or Specialized Certifications:
Standard IRB-required courses must be completed and appropriate exams passed with necessary certification within 2 weeks of start date.
Will need to complete NIOSH Spirometry training and maintain up-to-date phlebotomy certification.
Any Specific Physical Requirements for the Job:
Sittingin a normalseatedpositionforextendedperiods of time.
Reachingby extendinghand(s) or arm(s) in any direction.
Fingerdexterityrequiredto manipulateobjectswithfingersratherthanwithwholehand(s)orarm(s),forexample,using a keyboard.
Communicationskillsusing the spoken word.
Classified Title: Research Technologist Working Title: Research Program Coordinator Role/Level/Range: ACRO40/E/03/CD Starting Salary Range: $16.26-$22.35 Employee group: Full Time Schedule: Monday-Friday/8:30am-5:00pm/40 hours Exempt Status: Non-Exempt Location: 33-MD:Johns Hopkins Bayview Department name: 10002817-SOM DOM Pulmonary Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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 HR Business Services Office at firstname.lastname@example.org. For TTY users, call via Maryland Relay or dial 711.
The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.
During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.
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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