Sr Clinical Research Program Manager - 116785

Requisition ID: 116785

Sr Clinical Research Program Manager

We are seeking a Sr Clinical Research Program Manager to work under the Director of the Upper Aerodigestive Cancer Program (UAD) and the Director of Clinical Research Administration. Will be responsible for the overall management of the clinical trials portfolio and clinical research activities within the UAD Program, both on the East Baltimore and Bayview campuses. The candidate will be responsible for managing research staff, developing and implementing effective data management and regulatory procedures, providing education to research staff and ensuring research staff are properly trained. Will have a dual reporting relationship to the Director UAD Program and Director of Clinical Research Administration. Must adhere to guidelines regarding honest reporting of sensitive and confidential patient information. Must understand the importance/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. This description is a general statement of required major duties and responsibilities performed on a regular and consistent basis by the incumbent(s). It should not be held to exclude other duties not mentioned that are similar in nature and level of difficulty.

Specific Duties & Responsibilities

Responsible for the recruitment, education, training and supervision of the clinical research coordinators and regulatory personnel within the Program.

• Responsible for recruiting and supervising research staff in the Program, and working closely with senior staff for data management and/or regulatory personnel recruitment. Work closely with the Research Nurse Manager to recruit research nursing personnel.
• Actively assess workload and assignments among all research staff in the Program.
• Facilitate effective teamwork among research nursing, data management, and regulatory personnel.
• Responsible for development and implementation of policy and procedures for clinical research within the Program.
• Develop and conduct continuing education training for all research staff.
• Facilitate collaboration between Oncology, Radiation Oncology, and other pertinent departments to enable multidisciplinary clinical research operations.
• Facilitate collaboration between Hospital and University personnel including data management, inpatient, outpatient and research nursing, house staff and faculty.
  
  
  

Responsible for resource utilization and prioritization within the Program.

• Direct meetings to discuss the current and upcoming clinical trials portfolio and active research issues and staffing needs.
• Meet regularly with Program leadership to discuss availability of resources and prioritization of protocols.
• Meet regularly with Oncology Financial Administration to review clinical trial billing and staff effort distribution.
• Supervise space allocation within the designated work area.
  
  
  

Ensure responsible conduct of clinical research protocols throughout the lifecycle, including development, implementation, maintenance, and termination.

• Assist PIs with research protocol evaluation, including reviewing and assessing new protocols for clarity, thoroughness, financial and logistical feasibility, maintaining subject safety etc.
• Track and oversee the regulatory approval process to ensure efficient study startup; assist regulatory staff with informed consent and protocol amendments for investigator-initiated studies, as needed.
• Work with research coordinators, inpatient/outpatient nurses, research nurses, research pharmacy, and other clinical departments to optimize the practical implementation of each protocol.
• Ensure the proper scheduling and initiation of required research activities with sponsors of clinical trials as needed.
• Oversee regulatory compliance; ensure research staff maintain complete and accurate research data and charts in a real time basis and are well prepared for auditing and monitoring visits.
• Ensure SKCCC Standard Operating Procedures are in practice.
• Facilitate and maintain effective communication with research sponsors, lead organizations, and regulatory agencies.
  
  
  

Manage clinical research budget generation and financial management of the Program in collaboration with Oncology Financial Administration.

• Establish and oversee a process to ensure OnCore calendars, Beacon builds and Prospective Reimbursement Analyses are complete and accurate.
• Work closely with Oncology Financial Administration to build clinical trial budgets and maintain a system for tracking and reporting milestones for clinical research invoicing within the Program.
• Analyze resource utilization by individual trials and within the Program to ensure research needs are anticipated and met.
• Work closely with other Clinical Research Program Managers and other Departments to help create effective, efficient research systems, and avoid duplication of effort.
• Participate in Cancer Center-wide initiatives and working groups as needed.
  
  
  

Special Knowledge, Skills & Abilities

• Excellent organizational skills.
• Excellent attention to detail skills.
• Knowledge of medical terminology.
• Familiar with medical procedure and laboratory fees.
• Ability to manage multiple and competing priorities.
• Knowledge of clinical research practices and principles.
• Ability to understand a clinical trial financial contract.
• Must have excellent time management skills.
• Must have excellent oral and written communication skills.
• Ability to work in a team and demonstrated interpersonal skills.
  
  
  

Minimum Qualifications

• Master's Degree in related discipline required.
• Eight years related experience, including significant experience conducting large research projects.
• Additional education may substitute for one year experience to the extent permitted by the JHU equivalency formula.
  
  
  

Preferred Qualifications

• PhD
• Extensive experience with clinical research sciences, regulatory affairs.
• Extensive experience with protocol and informed consent writing, data analysis, grant writing, and manuscript preparation and production.
• Certification as a Clinical Research Professional.
  
  
  

Classified Title: Sr. Clinical Research Program Manager

Role/Level/Range: ACRP/04/ME

Starting Salary Range: $64,600 - $113,300 Annually ($89,000 targeted; Commensurate with experience)

Employee group: Full Time

Schedule: M-F/8:30-5:00

Exempt Status: Exempt

Location: Hybrid/School of Medicine Campus

Department name: SOM Onc Upper Aerodigestive Cancer

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