Location: Baltimore, Maryland
Internal Number: 108304-en_US
Under the direct supervision of the Clinical Research Program Manager, we are seeking a Research Program Coordinator who will be responsible for monitoring and collecting research data for complement associated diseases in the Division of Hematology. The Research Program Coordinator is responsible for the organization, entry, maintenance and accuracy of clinical research data for complex and detailed clinical trials. The Coordinator will help with consenting, collecting research samples and delivering them to the lab, and helping to prepare monthly data reports to the PI and collaborating investigators. May collaborate in development and writing of protocols and consent forms, in development and preparation of regulatory documents as appropriate and clarifying concerns and questions about new protocols with PI and Sponsor.
Specific Duties & Responsibilities
- Supports recruitment, screening and enrolling of eligible patients into laboratory protocols.
- Explain the protocol in detail and conduct informed consent procedures with potential research participants.
- Maintain good working knowledge of all assigned protocols and reporting requirements. Work on complex clinical and research studies which require a high level of knowledge, coordination, and data abstraction.
- Maintain regulatory binders/spreadsheets for assigned protocols. Prepare and submit annual renewal requests, amendments and adverse event reports with clinical input according to IRB and Sponsor requirements. Adhere to all protocol requirements to ensure the validity of the clinical research data.
- Assist the principal investigator and grant/program manager in defining information and plans required to accomplish goals of studies. Design and create protocol specific case report forms as needed.
- Verify patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements.
- Collect, enter and compile clinical data from a variety of sources. Ensure accuracy and timeliness of data so that information may be used by the physicians in treatment planning for individual patients, and by the Principal Investigator in grant writings, presentations and publication.
- Compile materials which aid physicians/other staff in complying with protocol requirements.
- Participate in all mandatory meetings to develop increasing knowledge of assigned research and clinical trials.
- Develop and maintain a protocol database or spreadsheet for tracking patient activity, data collection, and financial management.
- Prepare for and participate in monitoring and audits of studies. Write responses to audit reports with input from the Principal Investigator.
- Complete minimum requirement for continuing educational units. Is knowledgeable of and complies with Good Clinical Practices, ICH Guidelines and Departmental Research Office policies. May instruct introductory level research personnel in these guidelines and policies.
- Prepare and submit invoices to sponsors in a timely manner.
- Perform all other duties as assigned.
Special Knowledge, Skills, & Abilities
- Excellent organizational skills required. Excellent attention to detail skills required.
- Must have ability to manage multiple and competing priorities. Must have excellent time management skills.
- Must have excellent oral and written communication skills.
- Must be able to work independently.
- The successful applicant will demonstrate an ability to work well with other professionals with minimal supervision, and be comfortable being part of a diverse professional team.
*This description is a general statement of required duties and responsibilities performed on a regular and continuous basis. It does not exclude other duties as assigned.
- Bachelor's Degree in related discipline.
- Proficiency in the use of common software applications, databases, spreadsheets, and word processing required.
- Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.
- Bachelors Degree or equivalent.
- Experience with working and interacting with patients of at least one year.
Classified Title: Research Prgram Coordinator
Starting Salary Range: $16.75-$23.00-$29.30 HRLY (Commensurate with experience)
Employee group: Full Time
Schedule: M-F, 40hrs
Exempt Status: Non-Exempt
Location: School of Medicine Campus
Department name: SOM DOM Hematology
Personnel area: School of Medicine
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.
The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion.
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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.
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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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