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 to monitor the clinical course and collection of research data on patients entered in NIH funded and industry sponsored multi-site protocols and clinical trials. Will oversee recruitment, enrollment and follow up of research participants.
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 processes.
Develops and maintains collaborative relationships with members of other health care disciplines, such as the CT scan team and clinical laboratories, to facilitate research outcomes.
Maintains detailed working knowledge of all assigned protocols. Share internal study progress report periodically or as needed.
Prepares Change in Research and Continuing Review applications for IRBs submission.
Prepares initial protocol submissions, develops consent forms and other regulatory documents in compliance with federal, university, departmental and other regulations.
Reviews and assesses new protocols/protocol amendments for clarity, thoroughness, logistical feasibility, maintaining subject safety. Reviews protocol amendments to identify changes to treatment orders, study calendar and risks to subjects. Lists and clarifies concerns & questions about new protocols with PI &/or sponsor.
Communicates these changes to subjects, either verbally or through written re-consent, as determined by the IRB.
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 about, 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 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).
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.
Monitors and ensures compliance with the protocol treatment and study schedule.
Monitors study calendar of various clinical protocols and coordinators the logistics needed for successful completion of studies.
Develop recruitment strategies and create advertisements to ensure goals of multiple studies are met in a timely fashion
Schedules patient appointments and follow-up visits/phone calls at the appropriate time to assure completion of protocol requirements.
Performs, and/or monitors clinical procedures and structured tests, such as lung function tests (spirometry) phlebotomy, per protocol requirements.
Design case report forms and manuals of operations according to written study protocols.
Anticipates and prepares needed space for study-related equipment and supplies.
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 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 status of subjects.
Prepares reports on individual patients or the study as required by the principal investigators and/or external agencies.
Provides support and guidance to the research staff to facilitate ongoing progress toward project goals and to ensure quality of work. Responsible for ensuring the successful attainment of study goals within timelines. Meet weekly with research staff to review the completion and progress of multiple studies and to ensure recruitment milestones are met. Schedule meetings with staff and investigators as needed.
Keep investigators and team informed of study developments and upcoming meetings and deadlines. Works with Research Program Manager and PI independently to identify new or changing staffing needs.
Responds in a timely manner to special projects or queries related to the data. If needed, Coordinate data analysis with external statisticians.
Others if needed: Organize bio specimen repository, ensuring quality control of samples collected/stored and shipped in collaboration with Lab Coordinator. Transport biological samples to the final lab. Help clinic coordinator with escorting participants, etc.
Minimum qualifications (mandatory):
Bachelor's degree in related discipline required.
Three years of related experience required. Additional education may substitute for some experience, to the extent permitted by the JHU equivalency formula.
Experience with drug intervention trials
Experience with budgeting, invoicing, NIH progress reports, eIRB management
Petty cash disbursement and reconciliation experience
Experience using SAP
Experience using REDCap
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
Any specific physical requirements for the job:
Sitting in a normal seated position for extended periods of time
Reaching by extending hand(s) or arm(s) in any direction
Finger dexterity required to manipulate objects with fingers rather than with whole hand(s) or arm(s), for example, using a keyboard
Communication skills using the spoken word
Ability to see within normal parameters
Ability to hear within normal range
Ability to move about
Ability to attend to information presented one-on-one and during staff meetings.
Ability to lift 40 lbs.
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: M-F; 7.5 hours per day Exempt Status: 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.
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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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