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Clinical Research Manager (Pulmonary)
Clinical Research Manager (Pulmonary)InsideHigherEd • Baltimore, Maryland, United States
Clinical Research Manager (Pulmonary)

Clinical Research Manager (Pulmonary)

InsideHigherEd • Baltimore, Maryland, United States
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  • [job_card.full_time]
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Researchers at Johns Hopkins University conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. We are seeking a Clinical Research Manager who will work under the general supervision of a PI(s) to manage the administrative and scientific implementation of a complex clinical protocol or multiple studies and/or multiple sites. As part of a study team, collaborate with faculty, develop protocols, develop SOPs, and supervise study-related activities for one or more studies. Has accountability for grant submission and administration and regulatory compliance. Supervise or oversee other exempt level research staff; may oversee staff at local or multi-center sites.


Specific Duties & Responsibilities

  • Partner with investigator(s) and exercise independent judgement in managing the conduct of the research on behalf of the PI.
  • Participate in scientific discussions with collaborators, PI's, and funding organizations.
  • Collaborate with PI to ensure operational feasibility of proposed protocol/study design.
  • Develop, or oversee the development of standard operating procedures and data collection forms from protocol(s).
  • Develop or oversee the development of consent form(s) for clinical trials based on protocol(s).
  • Oversee preparation and submissions to IRB and act as primary liaison for regulatory compliance issues on behalf of the PI.
  • Train and provide oversight of research data management and regulatory issues.
  • Work with commercial and/or government agency sponsors to determine what group can commit to considering patient population, available resources, and cost of providing services.
  • Collaborate with the finance team to develop study budget(s) and ensure that all study costs are included in the budget.
  • Ensure clinical research protocol has a completed Prospective Reimbursement Analysis (PRA) and processes/systems are in place to ensure the PRA is followed when required.
  • Ensure adequate system for tracking and reporting clinical research milestones for financial invoicing.
  • Monitor activities, systems, and processes to increase referrals and increase accruals to clinical trials.
  • Ensure the development, testing, and evaluation of manuals, questionnaires, and coding structures, for the efficient collection of data.
  • Oversee data collection at a single site or at multiple sites of a multi-centered clinical trial.
  • Lead study meetings to examine data, determine next steps, implement changes to protocol operations based on results and goals, and initiate sub-studies.
  • Contribute to presentations and manuscripts.
  • Hire, supervise and manage performance of other exempt-level research staff.
  • Other duties as assigned


Minimum Qualifications
  • Bachelor's Degree in a related field.
  • Five years of related experience in clinical research in an academic, government, or pharmaceutical industry environment.
  • Additional education may substitute for required experience, and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.


Preferred Qualifications
  • Master's Degree in a related field.
  • Certification as a Clinical Research Professional.

Classified Title: Clinical Research Manager
Role/Level/Range: ACRP/04/MD
Starting Salary Range: $55,800 - $97,600 Annually ($56,000 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: Monday to Friday 8:30am - 5pm
FLSA Status: Exempt
Location: School of Medicine Campus
Department name: SOM DOM Pulmonary
Personnel area: School of Medicine

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Clinical Research Manager (Pulmonary) • Baltimore, Maryland, United States

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