The Division of Clinical Pharmacology Drug Development Unit is seeking a Senior Research Coordinator who will be conducting clinical studies sponsored by pharmaceutical companies, government agencies, and Johns Hopkins investigators. Subject populations involved in the studies include healthy adults and various populations with disease.
The person in this position will:
Work on multiple complex clinical studies which require a high level of knowledge, coordination and data abstraction
Maintain detailed knowledge of all assigned protocols, adhere to all protocol requirements to ensure the validity of the clinical research data, and transmit/distribute protocol information as needed
Interact with faculty, fellows, and staff of various divisions/departments of the Johns Hopkins School of Medicine.
Essential Job Functions:
The person in this position will:
Understand and adhere to schedules, protocols, and Standard Operating Procedures (SOP).
Communicate with others in the DDU and the division to express ideas, make suggestions, seek help as necessary, and to work as part of a team.
Take responsibility for completing tasks within specified timeframes.
Complete and maintain up to date documentation of human subjects' research training required by the JHM IRB, DDU, and protocol Sponsors including and not limited to: JHM Research Compliance, HIPAA, Bloodborne Pathogens, and CPR.
Attend and participate in weekly staff and division meetings, protocol and research related meetings and trainings, performance improvement and quality assurance activities, and other meetings as required or assigned.
Assist investigators in defining information and plans required to accomplish goals of the clinical trials.
Prepare essential documents and maintain a binder and data base of IRB submissions for protocol initiations, annual renewals, further study actions, adverse events, and progress reports according to IRB and sponsor requirements.
Develop and maintain a protocol database and spreadsheets for tracking patient activity, financial management and data analysis.
Prepare and maintain study specific data base and documents for research charts e.g. source documents and case report forms when these are not supplied by a sponsor.
Perform subject recruitment; develop advertising and recruitment materials, post flyers, and place advertisements in newspapers, websites, or other venues as determined by study team.
Inform potential study subjects about research studies, procedures, and protocol requirements.
Explain the informed consent process to subjects, obtain, and document subject informed consent.
Conduct screening interviews and administer screening questionnaires.
Collect study required data from patients, charts, electronic databases, clinical and research laboratories, imaging services and other sources.
Assess eligibility of potential study subjects comparing patient history and clinical laboratory results with study specific inclusion and exclusion criteria.
Enroll eligible subjects into studies and provide eligibility source documentation for all patients enrolled in the study.
Maintain study subject rosters to track and document status of subjects and complete screening, enrollment, completion, dropout, and termination information reports.
Provide patient education as needed to enhance subject safety and compliance with study.
Prepare orders and perform protocol-specific in-service training for nursing staff and scheduled admissions on the inpatient Clinical Research Unit (CRU Osler 5).
Order and inventory clinical supplies necessary for performance of studies.
Assemble PK kits and admission documentation to be supplied for inpatient CRU study visits.
Schedule subjects for admissions, appointments, tests, and follow-up visits at the appropriate time to assure completion of protocol requirements.
Coordinate and complete subject study visits according to study protocol to include vital signs, ECGs, phlebotomy, obtaining clinical samples, and performing health assessments.
Design and compile materials which aid physicians and other staff in complying with protocol requirements for these visits and tests.
Collect, compile, and maintain data in a research chart for each patient from a variety of sources.
Organize and enter subject and protocol data into DDU Volunteer, study roster, and other databases
Communicate with laboratories or investigators regarding laboratory findings.
Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
Monitor to confirm accuracy and timeliness of protocol procedures and data entries so that data information may be used for presentations and publication.
Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions.
Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data
Respond in a timely manner to special projects or queries related to the data.
Manage and document subject remuneration per IRB approved protocol specific plan and DDU SOP.
Oversee personnel who may be assisting with any of the above duties.
Meet regularly with Principal Investigators, Associate Director, or Sr. Research Nurse to review data accuracy and overall study progress.
Prepare reports on individual patients and descriptive statistics for the protocol as required by the Principal Investigator or Sponsor.
Collaborate with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.
Meet with clinical trial financial management staff as needed to identify procedures, laboratory tests and protocol events that require invoicing to the sponsor as defined in the financial contract.
Participate in relevant DDU, protocol, sponsor, and Clinical Pharmacology meetings as required to remain current and increase knowledge of clinical trials.
Be willing and available for travel to research and study related meetings if deemed necessary by the PI.
Be available to work evenings and/or weekends per study requirements if scheduled in advance.
Additional duties may be required that are not yet identified.
This description is a general statement of required major duties and responsibilities performed on a regular and continuous basis. It does not exclude other duties as assigned.
Scope of Responsibility:
Will have knowledge of the policies, procedures and practices necessary to conduct the work described above and an awareness of the role and importance of the position within the DDU and its potential impact on the working unit.
Will be responsible for own work.
Demonstrate an ability to work well with a diverse professional team and with minimal supervision.
Exercise professional judgment and assume responsibility for own decisions, actions, results and consequences.
Reports to the research manager in the Drug Development Unit (DDU).
Indirectly supervises ICTR Clinical Research Unit nurses and dietitians working with subjects and laboratory personnel processing subject samples.
The person in this position will be expected to exchange complex and detailed information in an appropriate manner requiring strong oral and written communication skills.
Minimum Qualifications (Mandatory):
Bachelor's Degree with 3 years of experience.
Proven experience and successful work history in a comparable clinical trials research environment.
Knowledgeable of and compliant with the Code of Federal Regulations Title 21-Good Clinical Practice Parts, 11, 50, 54, 56, and 312; with the International Conference on Harmonisation Good Clinical Practice Guideline (E6); and with the policies and guidelines of the Johns Hopkins medicine IRB, and SOPs of the DDU and clinical trial sponsors.
Demonstrated organizational and time management skills with a high degree of attention to detail.
Ability to manage multiple and competing priorities.
Proficiency working with computers and various software applications, especially Microsoft Excel and Microsoft Word, the World Wide Web and electronic mail.
Current CPR certification required.
Certification as a SOCRA or ACRP Clinical Research Coordinator preferred.
Work produced is subject to precise measures of quantity and quality.
Near vision to see objects clearly within 20 inches.
Sharp focus to adjust vision when doing close work that changes in distance from eyes.
Full spectrum vision to identify and distinguish color.
Finger dexterity required to manipulate objects with fingers rather than with whole hand(s) or arm(s), for example, using a keyboard.
Handling by seizing, holding, grasping, turning or otherwise working with the hand or hands, but without finger dexterity.
Occasionally lifting, carrying objects weighing 20 lbs. or less.
Occasionally pushing, pulling objects weighing 20 lbs. or less.
Ability to move about without restriction.
Classified Title: Sr. Research Program Coordinator Role/Level/Range: ACRP/03/MB Starting Salary Range: $37,700 - $51,900 annually (commensurate with experience) Employee group: Full Time Schedule: 30 hours/week .75FTE Exempt Status: Exempt Location: School of Medicine Campus Department name: SOM DOM Clinical Pharmacology 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 firstname.lastname@example.org. 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.
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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