The Johns Hopkins Clinical Research Network (JHCRN) is a JH School of Medicine resource to facilitate clinical research across multiple institutions through the Mid-Atlantic States. The Network Clinical Research Program Specialist is Hopkins-based and works in partnership with the Director, leadership team and the affiliate site Network Coordinators to:
1) Implement strategic initiatives of the JHCRN; work to grow the network through collaborations with external regional health care institutions.
2) Work with faculty to identify and obtain funding for research studies suitable for the JHCRN; organize and engage with participants at meetings to formulate ideas and feasibility of grants; interact with external research sponsors to determine their needs.
3) Coordinate and oversee operational aspects of research programs; Develop and implement efficient and compliant bidirectional work flow processes that support general research administration, project and subject management, as well as quality monitoring;
4) Establish and maintain collaborative relationships and facilitate communication with internal and external partners and stakeholders; and ensure program compliance with government regulations, University policies, and Institutional Review Board (IRB) requirements, and prepares regulatory reports.
Specific Duties & Responsibilities:
Work with the JHCRN affiliate site Network Coordinators (NCs) in the implementation of research studies across institutions.
Work with investigators and JH offices to develop proposals and budgets, research plans, cost estimates, budget justifications, and statements of work.
Assesses the operational feasibility of studies and recommends execution and risk mitigation plans.
Work with site NCs to draft and track study timelines, budget, and quality metrics.
Ensure adherence to standard operating procedures and Good Clinical Practice (GCP) regulations. Assist investigators with regulatory requirements, including human subjects' research compliance and the Institutional Review Board (IRB) submissions.
Work with JHCRN site NCs to develop and institute proper quality control measures for ongoing studies and ensure that all processes are performed in the most efficient, high quality manner.
Interact with JH offices in the preparation and submission of grants; work with staff to meet grant deadlines for all new and competing grants by compiling data and draft initial information for grant development.
Participate in a weekly meetings with network coordinators to discuss the current and upcoming clinical trials portfolio, active research and operational issues.
Contribute to the preparation of technical reports, manuscripts, abstracts, presentations, and funding applications by participating in compiling data relating to regional demographics, patient/study participant data, and so forth.
Promotes the JHCRN both to investigators within the Johns Hopkins Medical Institutions and with potential private industry/research sponsors.
Assist Associate Program Directors in their specific role and agendas.
Develop and implement standard operating procedures, and performance databases.
Facilitate communication internally among members of the team, including maintaining action items, timelines and work plans.
Attend team and project meetings/ conference calls, and prepare minutes of meetings when applicable.
Organize/facilitate project related logistics.
Assist with onboarding new research faculty, network coordinators and other network members.
Attend related local and national meetings and conferences.
Serve as a resource for investigators, network coordinators and stakeholders on procedures to expedite research study processes through the JHCRN.
Organize and communicates CRN progress results, analyses and other information for written, graphic, pictorial or multimedia presentations.
Collect, validate and enter data using established tools, technology and databases to facilitate data analysis.
Assist with the preparation of scientific abstracts, posters, PowerPoint presentations, and manuscripts by compiling data.
Occasional travel to affiliated sites will be necessary.
Complete other duties as assigned by the JHCRN Director.
Requires bachelor's degree in related discipline, preferably in health-related sciences.
Requires a minimum of 5 years of experience in clinical research, overseeing research administrative activities, implementation of research protocol(s) for complex and/or multiple research studies, and records management.
Experience in conduct of industry-sponsored and investigator-initiated research studies.
Ability to successfully problem-solve challenges as they arise
Excellent oral and written communication skills as well as interpersonal skills required.
Strong working knowledge of MS Access, Excel, Word, and PowerPoint
Ability to work collaboratively and effectively with faculty, administration, and staff
Additional education may substitute for some experience, 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.
Master's preferred (Public Health, Business or other related discipline).
Good organizational, management, planning, analytical, and critical-thinking skills helpful.
Experience in implementing research programs, quality assurance, and program evaluation helpful.
Special Knowledge, Skills, and Abilities:
Ability to manage multiple and competing priorities.
Ability to work independently as well as with various research teams.
Excellent time management skills.
Excellent attention to detail.
Must have a working knowledge of federal regulations pertaining to clinical trials, research (FDA, OHRP), and good clinical research practices and principles (GCP).
Must adhere to policies related to protecting and reporting of sensitive and confidential patient information.
Must understand the importance and impact of data integrity in terms of patients, study results, costs, quality of service, and scientific research in general.
Regular contact with physicians, other health care personnel and occasionally, patients, requires the use of good judgment, tact, and sensitivity.
Classified Title: Clinical Research Program Specialist Working Title: Network Clinical Research Program Specialist Role/Level/Range: ACRP/04/MC Starting Salary Range: $55,000 - $72,000; commensurate with experience Employee group: Full Time Schedule: Monday-Friday/8:30am-5:00pm Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10003311-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.
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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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