The Department of Neurology is seeking a Clinical Trials Research Program Manager for the Multiple Sclerosis Center. The Clinical Trials Research Program Manager will have primary management responsibilities for all aspects of on-going existing investigator and/or industry initiated clinical trials and research staff. This position will report to the Center's Project Administrator and will work 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 Clinical Trials Research Program Manager will also contribute to building the capacity of the Center's research program by providing guidance on budget planning, the effective utilization of resources, and development and implementation of trainings for personnel to effectively carry out research activities.

Specific Duties & Responsibilities

• Manage day-to-day research activities and staff for several research studies.
• Responsible for the recruitment, education, training and supervision of the clinical research coordinators.
• Work directly with the principal investigators, study coordinators, and research fellows 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.
• Provide protocol training to research staff.
• In coordination with the Project Administrator develop policies and procedures for clinical research and continuing education and research staff within the Center implement policies and procedures; conduct and update trainings.
• Responsible for overall effective and efficient management of program activities.
• Actively assess workload and assignments among research staff.
• Facilitate effective teamwork among research staff and fellows, data management, and other personnel.
• Communicate regularly with principal investigators and collaborators to review study progress.
• Communicates with CROs throughout the lifecycle of the trials.
• Prepares and maintains study protocols and reports for the Institutional Review Board and sponsors; trains coordinators and other staff on IRB processes.
• 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.
• Assures project management tasks are completed (i.e. prioritize, timeliness, milestones, monitoring, status).
• 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.

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 (or willingness to learn and apply learning).

• Bachelors' Degree, preferably in health-related sciences. 
• Requires minimum of five year's experience in clinical research at an academic, government, or pharmaceutical industry environment.
• Requires minimum of one year of management experience.
• Requires experience in clinical research and regulatory affairs.
• Experience in protocol and informed consent writing, data analysis, grant writing, and /or manuscript preparation required.
• Experience in budget generation, contractual process and financial management of clinical trials preferred.
• Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.

• Master's Degree preferred.

Classified Title: Clinical Research Program Manager 
Working Title: Clinical Trials Research Program Manager   
Role/Level/Range: ACRP/04/MD  
Starting Salary Range: Min $55,200 - Max $96,600 Annually ($75,900 budgeted; Commensurate with experience) 
Employee group: Full Time 
Schedule: M-F 8:30 am - 5:00 pm 
Exempt Status: Exempt 
Location: Hybrid/School of Medicine Campus 
Department name: ​​​​​​​SOM Neuro Neuroimmunology  
Personnel area: School of Medicine 

Total Rewards
The referenced salary range is based on Johns Hopkins University's good faith belief at the time of posting. Actual compensation may vary based on factors such as geographic location, work experience, market conditions, education/training and skill level. 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/

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 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.

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.

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
Learn more:
https://www.eeoc.gov/sites/default/files/migrated_files/employers/poster_screen_reader_optimized.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 accessibility.jhu.edu.

Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. The COVID-19 vaccine does not apply to positions located in the State of Florida. 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. 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 on 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.

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

About Johns Hopkins University

Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to learn but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130 years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses throughout the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are based at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Bal...timore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.

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