The Multiple Sclerosis Center in the Department of Neurology is seeking a Clinical Trials Research Program Manager who will work under the direction of the Project Administrator and in collaboration with multiple Physician-Investigators. The Clinical Trials Research Program Manager has a pivotal role in the Center managing, wholly or in part, multiple industry-initiated clinical trials.
The Clinical Trials Research Program Manager will be a resource for physician investigators in the startup of new industry-initiated Clinical Trials and will oversee all aspects of on-going existing industry-sponsored Clinical Trials. The Research Program Manager will provide guidance on budget planning and the effective utilization of resources. The position reports to the division's Project Administrator, with an indirect reporting line to the faculty principal investigators of the clinical research projects.
Specific Duties & Responsibilities:
Manage overall day to day research administration activities and staff, including research program coordinators.
Work directly with the principal investigators and study coordinators to execute multiple clinical trial study protocols.
Have a thorough knowledge of study protocols as well as knowledge of the key principles of clinical trials design and practice. Maintain a good working knowledge of all assigned protocols and their requirements.
Responsible for overall effective and efficient management of program activities.
Communicate regularly with principal investigators and collaborators to review overall study progress.
Prepares and maintains study protocols and reports for the Institutional Review Board and sponsors.
Adhere to all protocol and regulatory requirements to ensure the validity of the clinical research data.
Assist with development and ongoing maintenance of standard operating procedures and work plans.
Responsible for hiring, orientation, and training of research staff.
Supervise one or more members of the research team.
Assure team productivity; develop and lead improvements in team functioning as required.
Serve as back-up to assist in the collection and processing of data and biospecimens.
Monitor project budgets and allocation of project resources.
May be involved in reconciling study related invoices.
Other duties as assigned.
Minimum Qualifications (Mandatory):
Bachelor's Degree in related discipline.
Five (5) years related experience. Demonstrated supervisory or lead responsibilities.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.*
* JHU Equivalency Formula: 18 graduate degree credits (semester hours) 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.
** 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.
Master's Degree in related field.
Special Knowledge, Skills & Abilities:
Excellent organizational and problem-solving skills.
Excellent time management skills.
Ability to manage multiple and competing priorities at once.
Excellent attention to detail.
Excellent oral and written communication skills.
Ability to work in a team and demonstrated interpersonal skills.
Ability to multi-task and function independently.
Knowledge of medical terminology required.
Familiar with medical procedure and laboratory fees.
Knowledge of clinical research practices and principles required.
Ability to understand a clinical trial financial contract.
1 or more Research Program Coordinators.
Classified Title: Research Program Manager Role/Level/Range: ACRP/04/MD Starting Salary Range: Commensurate with experience Employee group: Full Time Schedule: M-F 8:30 am - 5:00 pm Exempt Status: Exempt Location: School of Medicine Campus Department name: SOM Neuro Neuroimmunology Personnel area: School of Medicine
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: 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.
The successful candidate(s) for this position will be subject to a pre-employment background check.
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.
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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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