Under the direct supervision of the Program Manager and Research Supervisor, the Research Program Coordinator (RPC) will be responsible for participant recruitment, performing clinic visits which include administering questionnaires, blood draws, spirometry and other breathing tests. Will be involved in data collection, data quality and abstraction of research data on patients entered into clinic trials and research protocols.
Specific duties & responsibilities:
Conduct interviews over the phone or in person to determine eligibility for a research study.
Recruit and screen potential study participants according to inclusion and exclusion criteria; be knowledgeable of the protocol so that study activities are completed correctly and completely.
Pre-screen potential research subjects for participation in clinical trials (incl. Review of medical history, concomitant meds, pathology, and other relevant documents).
Research-related clinical tasks:
Coordinate participant visits and follow-up, schedule appointments with study participants, make telephone reminders, send recruitment letters, 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 clinic visits, which include administering questionnaires, blood draws, spirometry and other breathing and functional tests, as needed.
Perform routine tests in a research laboratory, help with 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).
Track and assess quality and completeness of data entry and abstraction; immediately raise potential concerns with 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.
Ensures 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, sponsor of clinical trials, Coordinating center / leading site (for NIH funded studies) and budget office & Office of Research Administration at JHMI.
Maintain detailed working knowledge of all assigned protocols.
Minimum Qualifications (mandatory):
Requires bachelor’s degree in related discipline and some related experience.
Additional experience may substitute for some education, to the extent permitted by the JHU equivalency formula.
Minimum of 3 years' experience in clinical research with a strong background in recruiting participants and pulmonary assessments is preferred.
Previous experience conducting clinical trial, preferably in hospital setting.
Experience with Drug interventional trials strongly preferred.
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.
Excellent verbal and written communication skills and interviewing techniques required.
Knowledge of clinical research practices and principles required.
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.
Decision Making: 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.
Technical qualifications or specialized certifications: Required: Standard IRB-required courses must be completed and appropriate exams passed with necessary certification within 2 weeks of start date. Must have current CPR certification.
Classified Title: Research Program Coordinator Working Title: Role/Level/Range: ACRO40/E/03/CD Starting Salary Range: $16.10-$22.12 Employee group: Full Time Schedule: M-F; 8:30am-5:00pm 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 email@example.com. 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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