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Job Req ID:  113721

Research Program Manager

The Department of Neurology is seeking a Research Program Manager who will deliver and organize work plans with 20+ clinical sites across the country in support of clinical trial research goals of the BIOS Clinical Trials Coordinating Center’s (CTCC). Activities include training and managing clinical and data entry personnel at numerous collaborating

centers in regard to specified trial cycle metrics, protocol fidelity, and oversight of local, institutional and federally required regulatory compliance across the network of collaborators.


Specific Duties & Responsibilities

  • Establish early lines of communication with the clinical teams as they are selected and prepared for activation.
  • Propel the subject accrual and monthly goals of enrollments per month across all sites.
  • Assist with site evaluations detailing the availability of critical local resources necessary to be successful at enrollment and protocol performance once the trial begins.
  • Assist sites in central IRB on-boarding, ensure timely and accurate submission to IRBs, sponsors and master agreements, local IRB/ethics committee review/approvals, and assist with the collection of all necessary regulatory documents needed before site activation for study subject enrollment.
  • Oversee site performance, assist with subject eligibility and randomization, identify local recruitment problems, personalize remediation programs with site teams, and help to assure that site investigators quickly implement local solutions to keep the recruitment goal on track for trial completion.
  • Conduct monthly (or more frequent) teleconferences with the clinical teams and individually mentor new coordinators.
  • Keep enrollments on track with established performance expectations.
  • Provide support for quality assurance monitors in all facets of work related to communications with and management of the enrolling center clinical teams.
  • Execute project management processes and methodologies to ensure projects are delivered on-time and within the budget, adhere to high quality standards, and benefit the investigative teams by ensuring smooth implementation of new trials from conception through study activation.
  • Will assemble project plans, team and work assignments, directing and monitoring work efforts daily, identifying resource needs, performing quality review, and escalating functional, quality and timeline issues appropriately.
  • Manage investigator relationships.
  • Track proposals and other documentation through signature/approval processes then through collaboration with Contracts personnel and IRB Navigators.
  • Facilitate meetings between project stakeholders and leadership and complete and maintain professional documentation for projects and deliverables, develop SOPs as needed, and assist in the auditing and monitoring of studies.
  • Handle information and be sensitive to project team, individual and all levels of organizational concerns; make use of data, statistical and quantitative analysis, explanatory and predictive modeling and fact-based management to drive decision making; and help investigators develop new insights and understanding of performance-based data.


Additional knowledge, skills, & abilities

  • Understands and can apply knowledge of clinical trial designs to trial execution.
  • Advanced knowledge and experience with GCP/ICH and local regulations.
  • Experience in web-based data collection applications.
  • Ability to prioritize own work and work of others as needed.
  • Strong organizational skills, analytical and problem-solving abilities, and attention to detail.
  • Ability to work with flexibility on several tasks simultaneously and to meet various concurrent deadlines.
  • Proficient in Microsoft Office Suite: Outlook, Word, Excel, PowerPoint, and Teams.
  • Proficient with SharePoint, collaborating and co-authoring of documents.
  • Possess the ability to learn new software programs such as electronic data capture software, eIRB, and project management software, which will be taught on the job.
  • Excellent leadership skills with ability to negotiate and work collaboratively.
  • Service-oriented with excellent verbal and written communication and organization skills.


Minimum Qualifications
  • Bachelor's Degree in related discipline.
  • Five years related experience, including demonstrated supervisory or lead responsibilities.
  • Project/system process lifecycle experience
  • Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.


Preferred Qualifications
  • Master's Degree preferred.
  • Knowledge of formal project management methodologies
  • Minimum of 2 years of direct project management.
  • Experience in a higher education of academic medicine environment.
  • Knowledge and experience with GCP/ICH and local regulations.
  • Experience in web-based data collection applications.

 

 

Classified Title: Research Program Manager 
Role/Level/Range: ACRP/04/MD  
Starting Salary Range: $55,200 - $96,600 Annually ($75,900 targeted; Commensurate with experience) 
Employee group: Full Time 
Schedule: M-F 8:30 am - 5:00 pm 
Exempt Status: Exempt 
Location: Remote 
Department name: SOM Neuro BIOS  
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:
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/.

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 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.
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