Network Research Program Coordinator

Location
Maryland, United States
Salary
Salary Not Specified
Posted
Jul 15, 2021
Employment Type
Full Time
The Institute for Clinical and Translational Research seeks aNetwork Research Program Coordinator(Assistant Research Navigator or 'ARN') who will work with the Research Navigators to provide research teams with a source of regulatory, administrative and project management information.This position will guide research teams during the review, submission and implementation of ICTR’s translational research grants. In addition, this position will play a key role in providing support throughout the research process for research teams requesting assistance. Support is either provided directly by this individual or through referral to appropriate resources. Resources can include ICTR support programs, as well as other resources both within and outside the Johns Hopkins system. This position will help ensure that research projects consistently and continuously maintain compliance with all applicable institutional requirements and regulations from external regulatory agencies. The ARN must stay up to date with all current rules and be prepared to work with the Research Navigators and/or research teams to implement any necessary changes. The ARN works with research teams independently and confers with more senior staff as necessary to efficiently address any question that may arise about the research at the institutional level.

Offices that the ARN will serve as a liaison include the Office of Research Administration, Office of Human Subjects Protection, Office of Research Billing and the Technology Transfer Office. The ARN will work with research teams to stream line the protocol approval process by helping them develop timelines and strategies for coordinating efforts between the various regulatory and administrative offices. This role reports directly to the Director of the Institute for Clinical and Translational Research (ICTR) Research Studio and Navigators support services.Under the guidance of the Research Navigator, ARN is responsible for working with multiple (up to 40) research teams to help translate their research into clinical protocols.

Specific Duties & Responsibilities:

    Supports the NCATS pre-approval process for Pilot Grants supported by the Johns Hopkins ICTR Assist with the 3 phases of the Accelerated Translational Incubator Pilot Program (ATIP) funding program:
      Phase 1, submission of new ATIP applications and 2 rounds of review to identify awardees. ARN will participate in:
        Performing triage review prior to forwarding to faculty reviewers to assess compliance with budgetary, content, eligibility and other submission guidelines Organizing meetings for reviewing rounds 1 and 2, including securing both internal and external reviewers Performing feasibility assessments of second round applications including a plan for securing all applicable regulatory approvals and agreements for required collaborations Providing "feasibility assessments” to the ATIP Advisory Group for Final Review
      Phase 2 of the ATIP funding program, investigators are awarded their grants. ARN will function as the project manager for the lifetime of the grant and report progress back to the ATIP Advisory group on whether or not project milestones are being met on a quarterly schedule. Phase 3 of the ATIP funding program, after the grant concludes. ARN will maintain contact with former ATIP awardees through surveys and interviews to track project development as requested by ICTR leadership.

    Help coordinate all components of the ATIP program, that require linkage to other entities such as the ICTR Studio and Studio experts, Cores, appropriate regulatory offices, etc.

    Regularly review with Principal Investigator and Research Coordinators overall study progress for all projects receiving ICTR funding and other projects as required by ICTR leadership. Discusses potential problems with investigators and suggests possible solutions. Assist in planning and implementing solutions as required.

    Serves as liaison between PIs, Research Nurses, Study Coordinators, research support/approval offices at JHMI and external regulatory agencies (e.g. FDA, RAC.) As appropriate, facilitate communication between PIs and common entities associated with research (e.g. NIH). Utilize a thorough knowledge of policies and procedures for approval and implementation of protocols to ensure work moves as quickly as possible through the system and to study completion.

    Consult and advise teams regarding preparation and maintenance of IRB and other institutional, regulatory documentation required for clinical and basic research projects.

    Consult and advise teams regarding preparation of documentation for outside auditors, corporate sponsors, or federal regulatory agencies like OHRP, the FDA, or NIH.

    Assist investigators in the development of standard operating procedures.

    Assist investigators in writing clinical protocols, and in defining information and plans required to accomplish study goals. As appropriate, will introduce the investigator to other resources or individuals within JHU who can assist with any question that cannot be addressed by the study team.

    Prepare annual and quarterly progress reports as directed by the ICTR Studio Director.

    Assist ICTR leadership with development of methods evaluating:
      Which types of studies benefit the most from the services of a Navigator Whether or not the ATIP funding program is providing a useful service to investigators If the Research Studio is fulfilling its intended purpose of a coordinated, multidisciplinary service center with a goal of facilitating clinical and translational research

    Work with ICTR Deputy Directors, Translational Core Directors, and other designated members of ICTR leadership, to operate the ICTR Research Studio. Responsibilities for operating the studio include:
      Organizing pre-Studio consultations with research teams to define research questions and identifying areas requiring assistance for further development Based on the pre-Studio consultation, conferring with Studio Director and an ICTR Deputy Director to decide which issues require a Studio consultation and which can be handled by referral to the appropriate resource Prepare for a Studio Consultation by ensuring the meeting is scheduled, all the reviewers have been invited and acknowledge their agreement to participate, and distributing to the reviewers all necessary background material Assists more senior staff with running the Studio consultation. Following the Studio consultation, create a written summary of the proceedings and follow-up with the investigator to get their feedback about the usefulness of the consultation
    Support the ICTR Translational Research Communities by:
      Familiarizing themselves with the subject area and translational pathways being discussed by the TRC Helping to address questions throughout the life cycle of a translational project (i.e. from pre-clinical investigations through concluding a clinical study) Providing regulatory and project management support for all TRC funded NEXUS projects

Minimum Qualifications (Mandatory):

    Bachelor’s degree is required. Requires a minimum of three years of research experience. Experience working with clinical trials and/or clinical research protocols at an academic, government, or pharmaceutical industry environment helpful. Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.

JHU Equivalency Formula: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.

Preferred Qualifications:

  • Master’s degree in public health
  • A bachelors’ degree in a science-related field is preferred.
  • Experience in the following areas is preferred: translational research, regulatory affairs, clinical trials, project management, and team-building also useful.

Special Knowledge, Skills & Abilities:

    Requires the ability to manage multiple and competing priorities and be organized. Ability to work independently as well as with various research teams. Effective interpersonal skills: must be an outgoing self-starter who can comfortably work with physicians and staff and get things done. Excellent oral and written communication skills. Proficiency in the use of software applications, databases, spreadsheets, and word processing required.

Physical Requirements:

  • Sitting in a normal seated position in office setting.
  • Standing and/or walking for extended periods of time.
  • Lifting and/or assisting patients during evaluations within crowded clinical environment.
  • 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.

Classified Title: Sr. Research Program Coordinator
Working Title: Assistant Research Navigator (ARN) for Human Subjects Protocol
Role/Level/Range: ACRP/03/MB
Starting Salary Range: $39,310 - $54,060 annually (commensurate with experience)
Employee group: Full Time
Schedule: M-F; 8:30am-5:00pm
Exempt Status: Exempt
Location: ​​​​​​​School of Medicine Campus
Department name: ​​​​​​​SOM ICTR Inst Clin Translational Resrch
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 atjhurecruitment@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.

Equal Opportunity Employer
Note: Job Postings are updated daily and remain online until filled.

EEO is the Law
Learn more:
https://www.eeoc.gov/sites/default/files/migrated_files/employers/poster_screen_reader_optimized.pdf

School of Medicine - East Baltimore Campus


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.

Equal Opportunity Employer
Note: Job Postings are updated daily and remain online until filled.

EEO is the Law
Learn more:
https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf
Important legal information
http://hrnt.jhu.edu/legal.cfm

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