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Requisition ID:  118818

Director, SOM Clinical Research Operations

We are seeking Director, SOM Clinical Research Operations who will implement and oversee all operational aspects of research within the Johns Hopkins University (JHU) School of Medicine (SOM) Office of Clinical Trials (OCT). This role serves all SOM Departments engaged in clinical trials and oversees the lifecycle of clinical trials in the complex regulatory and human participant protection ecosystem. The Director will provide regulatory guidance and support to a diverse group of investigators ensuring compliance with commercial and investigator-initiated sponsored projects. This position will serve as a liaison between investigators and clinical research support staff and will work closely with Administration to ensure that clinical trials are activated in a timely and efficient manner, focusing on Clinical Trials Agreements (CTA) review and negotiation as well as Institutional Review Board review processes. This multifaceted position and set of responsibilities require a special balance of perspective, maturity, and creativity, plus a commitment to excellence.


The primary role of the Director of Clinical Research Operations is the organization, coordination and implementation of clinical trials, and oversight and support of faculty and clinical research staff for the Office of Clinical Trial Office. The essential functions of the position include but are not limited to the following duties and responsibilities:


Specific Duties & responsibilities

  • Responsible for the planning, coordination, control, and continuous improvement of processes and methods used to regulate the efficiency and conduct of clinical research activities, including regulatory, budgetary, contractual.
  • As a key member in support of clinical research, the Director of Clinical Research Operations will play a major role in strategic efforts to provide high quality clinical research services in partnership with various stakeholders, including the Institutional Review Board (IRB), Human Subjects Research Protections Program (HRPP), Office of Research Administration (ORA), Institute for Clinical and Translational Research (ICTR) and other JHU and JHM entities.
  • Establish professional and effective relations with SOM partners to ensure that negotiations are focused and are completed in a timely manner.
  • Builds trust and inaugurates informal and formal relationship networks both internal and external to Johns Hopkins Medicine.
  • Ensures that work is carried out in strict accordance with Standard Operating procedures and in compliance with Good Clinical Practices.
  • Works with investigators, the Office of Research Administration (ORA), grants and contracts administrators, and legal counsel to oversee efficient negotiation of Collaborative Research Agreements (CRA), Clinical Trial Agreements (CTA), Material Transfer Agreements (MTA), and budget generation.
  • Hires, supervises, and evaluates the employees working in the OCT including but not limited to Clinical Research Regulatory Specialists, Clinical Research Coordinators, Research Nurses and support staff.
  • Establishes, maintains, and continuously refines structure to ensure the supervision and management of clinical research support staff within the OCT
  • Ensures that there is adequate training, assistance, guidance and support to investigators, coordinators and other research support staff in matters related to regulatory compliance.
  • Scope to include oversight for INDs and IDEs held by investigators and other ongoing research needs as identified.
  • Works with Research IT to ensure the optimal implementation, training and utilization related to research platforms including OnCore CTMS, eReg, DocuSign and clinical trials search.
  • Develops standard operating procedures and training programs for all research professionals across the JHU SOM and all its entities.
  • Develops and oversees the Accelerated Study Start-up Program, focused on facilitating and accelerating site activation for faculty-led commercial clinical trials at JHU SOM through coordination and partnership with central offices (JHM IRB, clinical research contracting, and budget building), Departments and research teams.
  • Provides metrics to Senior Associate Dean for Clinical Trials, the Vice Dean for Clinical Investigation, other departmental and institutional leaders to monitor OCT activities to include number and types of trials, enrollment, staff productivity, protocol activation, and resource requirements.
  • Works with the Director on annual budget planning as well as long term strategic and financial planning to confirm that resource needs are commensurate with the long-term growth of the program. Assists with the preparation of business plans to support resource requests.
  • Works with leadership to ensure that research priorities and resources are aligned, keeping abreast of clinical, scientific, and regulatory changes.
  • Works with leadership to identify resource needs, implement appropriate changes, and provide clear communication to faculty and staff.
  • Adjusts duties and responsibilities to meet the dynamic needs of the JHM clinical research ecosystem as needed


Supervision of Others

  • Directs the management of the OCT Full time equivalents consisting of, Clinical Research Coordinators, Regulator Affairs Coordinators, Administrative and Clerical staff.


Equipment, Machine, or Tool Requirements

  • General computer skills, with experience with Microsoft Office


Minimum Qualifications
  • Bachelor's Degree in Business, Systems Operations, Science, Healthcare Administration or related field.
  • A minimum of seven years of experience in clinical trials/medical research in an academic, government, or pharmaceutical industry environment.
  • Managerial level experience overseeing teams conducting clinical trials and other types of biomedical research.
  • Working knowledge of clinical research across different disease groups; regulations governing clinical research from an institutional, state, and federal perspective.
  • 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 related field
  • Certification as a Clinical Research Professional.
  • Experience in the regulatory affairs, project management, and team building.

This salary range does not include all components of the School of Medicine's compensation program. This position may be eligible for a discretionary bonus. Therefore, the actual compensation paid to the selected candidate may vary slightly from the salary range stated herein. For more information, please contact the hiring department. 

 

Classified Title: Director, Office of Clinical Trials 
Job Posting Title (Working Title): Director, SOM Clinical Research Operations   
Role/Level/Range: L/04/LG  
Starting Salary Range: $111,800 - $195,900 Annually ($130,000 targeted; Commensurate w/exp.) 
Employee group: Full Time 
Schedule: M-F 8:30 am - 5 pm. 
FLSA Status: Exempt 
Location: Hybrid/School of Medicine Campus  
Department name: SOM Admin Res Clinical Research Contract   
Personnel area: School of Medicine 

 

 

Total Rewards
The referenced base salary range represents the low and high end of Johns Hopkins University’s salary range for this position. Not all candidates will be eligible for the upper end of the salary range. Exact salary will ultimately depend on multiple factors, which may include the successful candidate's geographic location, skills, work experience, market conditions, education/training and other qualifications. 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/.

Education and Experience Equivalency
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 Completing Studies
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.

Background Checks
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.

Diversity and Inclusion
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
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.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 https://accessibility.jhu.edu/.

Vaccine Requirements
Johns Hopkins University strongly encourages, but no longer requires, at least one dose of the COVID-19 vaccine. The COVID-19 vaccine does not apply to positions located in the State of Florida. We still require all faculty, staff, and students to receive the seasonal flu vaccine. 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. This change does not apply to the School of Medicine (SOM). SOM hires must be fully vaccinated with an FDA COVID-19 vaccination and provide proof of vaccination status. 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 upon 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.
Hybrid: On-site 3-4 days a week

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