Research Program Coordinator

Location
Maryland, United States
Salary
$16.10-$22.12
Posted
25 Sep 2018
End of advertisement period
25 Nov 2018
Ref
11496
Contract Type
Fixed Term
Hours
Sessional

Role/Level/Range: ACRO37.5/03/CD 
Starting Salary Range: $16.10-$22.12
Employee group: Casual / On Call 
Schedule:
Employee subgroup: S1 Hrly Non-Exmpt 
Location: 200 North Wolfe Street 
Department name: 10003082-SOM Ped Infectious Disease 
Personnel area: School of Medicine

The Research Program Coordinator will conduct research trials for IMPAACT, ATN, and other government funded agencies and pharmaceutical companies. The candidate will work collaboratively with a multidisciplinary health care/research team to promote quality and excellence of care, optimize team performance and achieve divisional clinical, research and organizational goals and outcomes.

Specific Duties/Responsibilities:

The Research Program Coordinator will conduct research trials for IMPAACT, ATN, and other government funded agencies and pharmaceutical companies. The candidate will work collaboratively with a multidisciplinary health care/research team to promote quality and excellence of care, optimize team performance and achieve divisional clinical, research and organizational goals and outcomes.

Project Management: (75%) 

Pre-study:

  • anticipates research requirements for designated patient populations
  • With guidance, reviews & assesses new protocols for clarity, thoroughness, logistical feasibility, maintenance of subject safety
  • With guidance, lists & clarifies concerns and questions about new protocols with PI and sponsor
  • With guidance, evaluates the impact on and availability of resources for assigned clinical trials
  • Reviews prospective reimbursement analysis (PRA) as appropriate.

Pre-initiation:

  • As appropriate & with guidance, prepares & submits application and consent forms to the IRB
  • With guidance, prepares other forms required for study initiation (pre-printed orders, eligibility checklists, lab requisitions, etc.)
  • Determines that IRB approval has been received prior to initiation of research activity
  • Participates in study initiation meetings
  • Prepares space for study-related equipment & supplies.

Recruitment & enrollment:

Ensures initial & ongoing eligibility of all subjects for assigned research studies:

  • Screens potential research subjects for participation in clinical trials (including:
    • Review of medical history, concomitant meds, pathology, other relevant documents)
    • Evaluates ongoing eligibility of research subjects’ participation in clinical trials; collaborates with Principal Investigator to obtain exemptions as appropriate;
    • Abstracts data from a variety of sources to complete pre-study work-up
    • Demonstrates understanding of the informed consent process
    • With guidance & as appropriate, obtains informed consent from research subjects
    • As appropriate, documents obtaining of informed consent in medical record
    • Registers research subjects per sponsor guidelines
    • In conjunction with PI, monitors protocol enrollment goals
    • Demonstrates knowledge of protocol endpoint definitions
    • In collaboration with healthcare team, evaluates potential subjects for research participation.

Data collection/Document maintenance:

  • Ensures collection of pertinent data from internal & external sources & monitors compliance with requirements of assigned clinical trials:
    • Obtains & ensures proper distribution of required pharmacokinetic & tissue samples
    • Schedules, performs, and/or monitors procedures & tests per protocol requirements
    • Ensures correct documentation of clinical study in medical record and appropriate protocol documents. Schedules visits, tests & procedures for patients entered in clinical trials to ensure results are available in a timely manner
    • As appropriate, ensures all required signatures are obtained on informed consent documents
    • As appropriate, ensures validity of available informed consent documents
    • Maintains clinical research management system (CRMS) data base for enrollment
    • Reviews protocol amendments as required
    • Develops procedure and collection forms for pharmacokinetic sampling
    • With guidance & as dictated by research protocol, obtains required data through chart review, telephone communication, subject interview & assessment.
    • Coordinates with data managers to ensure delivery of trial data for inclusion into study files
    • As appropriate, & with assistance as needed, orders required medical equipment & supplies
    • Maintains working knowledge of institutional information systems for correctly scheduling clinical tests & procedures and extracting data
    • With guidance, organizes own time & sets priorities for research-related functions
    • With guidance, able to prioritize workload & manage multiple projects effectively
    • Achieves and maintains a working knowledge of computer software specific to department, including word processing, e-mail & internet functions
    • Aware of & knowledgeable about departmental Standard Operating Procedures.

Quality Assurance:

Evaluates outcomes of assigned clinical trials:

  • Recognizes and documents adverse events per protocol & ensures reporting to appropriate study & regulatory personnel; with guidance, initiates adverse event reports and ensures proper and timely distribution to sponsor and IRB
  • Ensures that appropriate team members grade identified toxicities per specified grading tables or protocol-specific criteria.
  • Attends staff meetings to review study progress
  • In collaboration with other members of the research team, prepares for and responds to study audits.

Communication

  • With guidance, assists in completion of annual periodic review of data for reporting to IRB, protocol sponsors, & cooperative groups
  • Documents written & verbal communication with study contacts
  • Communicates effectively with subject & family of active and prospective study participants
  • Communicates effectively with members of the health care and research teams.
  • Meets regularly with other members of the research team to review protocol progress and data collection
  • Attains proficiency in Web-based communication
  • Demonstrates understanding of the rules for advertising for subject participation, where appropriate.

Education: (10%) 

Ensures that patient and staff education needs are met with regard to assigned protocols.

Patient/Family Education

  • Ensures development and/or availability of appropriate protocol- and/or treatment-specific patient education materials
  • Determines effectiveness of patient/family education & modifies the education plan to most effectively address patient/family needs.

Staff Education

  • Identifies staff learning needs, including those based on requirements specific to designated research protocols
  • Ensures development & availability of appropriate staff education materials
  • Provides staff education related to assigned clinical trials (i.e., in-services)
  • Attends and participates in in-service and external trainings, workshops, conferences, and other relevant and/or required programs for professional growth and development.

Quality Management Activities: (15%) 

  • Reviews source documents and CRFS completed by other study team members for thoroughness and accuracy
  • Provides feedback and ensures that appropriate corrections are made.

Minimum qualifications:

Bachelor's degree in related discipline and some related experience required. Additional education may substitute for required experience and additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.

JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. 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.

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 jhurecruitment@jhu.edu. 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.

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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