Classified Title: Sr. Research Program Coordinator Working Title: Sr. Research Program Coordinator Role/Level/Range: ACRP/03/MB Starting Salary Range: $38,536 - $52,989 Employee group: Full-Time Schedule: Working 37.5 hours per week; Monday-Friday 8:30-5pm Exempt Status: Exempt Location: 33-MD:Johns Hopkins Bayview Department name: 10002817-SOM DOM Pulmonary Personnel area: School of Medicine
The Department of Pulmonary and Critical Care Medicine is seeking a Sr. Research Program Coordinator to work under the direct supervision of the Principal Investigator on monitoring the clinical course and collection of research data on patients entered onto NIH funded and industry sponsored multi-site protocols and clinical trials.
Specific Duties & Responsibilities:
Serves as the primary point of contact and liaison between PI, research staff, sponsor of clinical trials, Coordinating center / leading site (for NIH funded studies) and budget office & Office of Research Administration at JHMI.
Coordinates flow of communication between all entities involved in the research project. Manages administrative work flow to stream line the execution of contracts/subcontracts and protocol approval process.
Develops and maintains collaborative relationships with members of other health care disciplines for example CT scan team and clinical laboratories, to facilitate research outcomes.
Prepares Initial protocol submissions, develops consent forms and other regulatory documents in compliance with federal, university, departmental and other regulations.
Prepares Change in Research and Continuing Review applications for submission to IRBs.
Maintains detailed working knowledge of all assigned protocols.
Reviews and assesses new protocols for clarity, thoroughness, logistical feasibility, maintaining subject safety.
Lists and clarifies concerns & questions about new protocols with PI &/or sponsor
Coordinates with clinical trial and sub-award financial management staff to identify procedures, laboratory tests and protocol events that require invoicing to the Sponsor as defined in the financial contract.
Submits invoices to sponsors and confirms payments have been received by accounts receivable and posted to the internal order number.
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.
Participates in study initiation meetings.
Prepares space for study-related equipment and supplies.
Prepares for and participates in monitoring and audits of studies. Corrects errors in database when necessary. Writes responses to audit reports with input from the Principal Investigator.
Pre-screens potential research subjects for participation in clinical trials (incl. Review of medical history, concomitant meds, pathology, and other relevant documents).
Ensures insurance clearance requests are submitted and appropriate staff members are aware of insurance denials and follows up on status of appeals, etc.
Conducts and documents the informed consent process with subjects.
Ensures all required signatures are obtained on informed consent documents.
Ensures initial and ongoing eligibility of all subjects for assigned research studies.
Collaborates with the study coordinator in registering subjects to studies.
Schedules, performs, and/or monitors procedures and tests, per protocol requirements.
Obtains required data through chart review, telephone communication, subject interview & assessment.
Ensures correct documentation of clinical study activities in the databases and appropriate protocol documents.
Monitors and ensures compliance with the protocol treatment and study schedule.
Monitors subjects for adverse events and reportable SAEs per protocol-specific criteria.
Records and documents protocol deviations.
Presents PI with relevant information for determination of seriousness, causality, & intervention for adverse events.
Acts on the PI's recommendation for adverse event intervention.
Maintains follow-up to determine resolution of adverse event.
Provides study coordinator with timely data and prompt notification of SAEs, protocol deviations, treatment delays and end of treatment visits.
Communicates and collaborates with the PI, treating physician, study coordinator and other members of the study team on an ongoing basis regarding the implementation of the protocol and statuses of subjects.
Reviews protocol amendments to identify changes to treatment orders, study calendar and risks to subjects.
Communicates these changes to subjects, either verbally or through written re-consent, as determined by the IRB.
Prepares reports on individual patients or the study as required by the principal investigators and/or external agencies. Responds in a timely manner to special projects or queries related to the data.
Minimum Qualifications (Mandatory):
Bachelor's degree in related discipline. Additional education may substitute for experience.
Minimum of three years of related experience.
Experience with Drug interventional trials
Experience with budgeting, invoicing, and NIH progress reports
Petty cash disbursement and reconciliation experience
Experience using SAP
Special knowledge, skills, and abilities:
Excellent oral and written communication and interviewing techniques
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
Technical qualifications or specialized certifications:
Will need to complete IRB certification, CPR, NIOSH Spirometry
The successful candidate(s) for this position will be subject to a pre-employment background check.
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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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