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Job Req ID:  114022

Research Program Coodinator

We are seeking a Research Program Coordinator to 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


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.
  • Lists & clarifies concerns and questions about new protocols with PI and sponsor.
  • 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.
  • 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, orders required medical equipment & supplies.
  • Maintains working knowledge of institutional information systems for correctly scheduling clinical tests & procedures and extracting data.
  • 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:

  • Recognizes and documents adverse events per protocol & ensures reporting to appropriate study & regulatory personnel.
  • 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.
  • 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%)


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.
  • Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.


Preferred Qualifications
  • Research experience preferred.

 

 

Classified Title: Research Program Coordinator 
Role/Level/Range: ACRO40/E/03/CD  
Starting Salary Range: $17.00 - $30.00 HRLY ($22.06 HRLY targeted; Commensurate with experience) 
Employee group: Casual / On Call 
Schedule: M-F; up to 20 hours per week 
Exempt Status: Non-Exempt 
Location: Hybrid/School of Nursing 
Department name: ​​​​​​​SOM Ped Infectious Disease  
Personnel area: School of Medicine 

 

 

Total Rewards
The referenced base salary range represents the low and high end of Johns Hopkins University’s salary range for this position. Not all candidates will be eligible for the upper end of the salary range. Exact salary will ultimately depend on multiple factors, which may include the successful candidate's geographic location, skills, work experience, market conditions, education/training and other qualifications. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/.

Education and Experience Equivalency
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines: JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. 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.

Applicants Completing Studies
Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.

Background Checks
The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.

Diversity and Inclusion
The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion.

Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

EEO is the Law
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf

Accommodation Information
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 Talent Acquisition Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit https://accessibility.jhu.edu/.

Vaccine Requirements
Johns Hopkins University strongly encourages, but no longer requires, at least one dose of the COVID-19 vaccine. The COVID-19 vaccine does not apply to positions located in the State of Florida. We still require all faculty, staff, and students to receive the seasonal flu vaccine. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry. This change does not apply to the School of Medicine (SOM). SOM hires must be fully vaccinated with an FDA COVID-19 vaccination and provide proof of vaccination status. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/.

The following additional provisions may apply, depending upon campus. 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.
Hybrid: On-site 1-2 days a week

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