Job Information
Johns Hopkins University Research Program Coordinator in baltimore, Maryland
The Department of Medicine, Division of Rheumatology is seeking a Research Program Coordinator who will be responsible for coordinating clinical research activities within the Johns Hopkins Sjogren’s Syndrome Center. The individual’s responsibilities will include coordination of the NIH-funded STAMP (Sjogren’s Team-Accelerating Medicines Partnership) research project (75% effort) at Johns Hopkins and other clinical research activities within the Sjogren’s Center (25% effort). Requisite tasks will include patient recruitment and scheduling, data collection and management, specimen handling, compliance with IRB regulations, and administration of the STAMP research project. The individual will act as a liaison between the Principal Investigator, School of Medicine, Research Administration, GCRC, funding agencies and other study related organizations.
Specific Duties & Responsibilities
Clinical Research Activities
Assist the Principal Investigator with STAMP and other clinical research projects.
Identify potential study participants and assist in their recruitment into STAMP and other research studies
Assist clinicians with patient screening and verification of eligibility for specific research studies.
Obtain informed consent from potential study participants after providing a detailed description of the study, the study procedures, and potential risks, and answering all questions.
Schedule patients’ appointments and follow-up visits/phone calls at the appropriate time to assure completion of protocol requirements. This may require coordination of multiple appointments and centers.
Perform structured tests in the clinic and complete various assessment tools and questionnaires related to each study.
Collect patient source documents and case report forms for analyzing patient data.
Responsible for the organization, entry, maintenance and accuracy of patient clinical research data.
Coordinate same-day blood shipments for cohort studies to central lab for processing.
Act as primary contact for study participants, which may include scheduling, confirming appointments, and escorting/directing to various locations on campus
Establish study calendar of various clinical protocols and coordinate the logistics needed for successful completion of the studies.
Maintain detailed working knowledge of all assigned protocols. Adhere to all protocol requirements to ensure the validity of clinical research subject data.
Regulatory Compliance
Comply fully with institutional and external clinical research requisites.
Responsible for Institutional Review Board (IRB) submission, verification and maintenance of protocol specific information. Prepare and submit annual renewal requests, amendments, and safety reports according to IRB requirements.
Design and compile materials which aid physicians and other staff in complying with protocol requirements.
Maintain regulatory binders per protocols.
Document and report adverse events and protocol deviations.
Organize and create clinical research charts to be reviewed by regulatory agencies.
Complete training requirements for biohazard material handling and department of transportation (DOT) shipping requirements.
Be familiar with good clinical practice guidelines and knowledge of sponsor and FDA guidelines.
Data Management
Maintain and promptly update online Clinical Research Management System for each study protocol.
Assist with preparation of data for reports and presentations.
Respond in a timely manner to special projects or queries related to data.
Design and implement procedural adjustments to increase accuracy and efficiency of data collection and entry process.
Perform quality checks on data entry.
Ensure accuracy and timeliness of data collection. Interact regularly and facilitate the completion of work with members of the research team regarding data management and the status and progress of ongoing studies.
Abstract patient clinical and demographic from a variety of sources and enter into tracking spreadsheet or data base.
Scholarly Activities
Assist with writing manuscripts and abstracts for publication.
Assist with development of grants, progress reports and study protocols.
Research Program Oversight
Meet regularly with Principal Investigators to review data accuracy and overall study progress.
Work with Center Manager and study sponsor (where appropriate) on problem recognition/resolution, accuracy of data gathered, and patient well-being, completion and collection of regulatory documents required by sponsors.
Prepare for and participate in audits of studies including follow-up items.
Financial Management
Keep records of expenditures and work with budget analysts to ensure accurate and prompt reporting of study financials.
Maintain compensation records for participants.
General
Carry out duties and responsibilities with limited supervision.
Travel to and participate in investigator and research coordinator meetings.
Maintain equipment and order research supplies related to clinical research protocols.
Report progress to Center Director and ensure satisfactory completion of research projects.
Minimum Qualifications
Bachelor's Degree in related discipline.
Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.
Classified Title: Research Program Coordinator
Role/Level/Range: ACRO40/E/03/CD
Starting Salary Range: $17.00 - $30.00 HRLY ($47,000 targeted; Commensurate with experience)
Employee group: Full Time
Schedule: M-F 8:30a-5p
Exempt Status: Non-Exempt
Location: Hybrid/Johns Hopkins Bayview
Department name: SOM DOM Bay Rheumatology
Personnel area: School of Medicine
Equal Opportunity Employer:
Johns Hopkins University is an equal opportunity employer and does not discriminate on the basis of race, color, gender, religion, age, sexual orientation, national or ethnic origin, disability, marital status, veteran status, or any other occupationally irrelevant criteria. The university promotes affirmative action for minorities, women, disabled persons, and veterans.