Create Alert
Apply now »
Requisition ID:  116799

Clinical Research Program Specialist

Under limited supervision of the Sr. Clinical Research Program Manager, we are seeking a Clinical Research Regulatory Specialist who will be responsible for managing regulatory start-up of clinical trials, assisting development of investigator-initiated studies, maintaining sponsor relationships, and facilitating compliance and continuing education trainings for the specific Urology Clinical Research Program. Regulatory start-up activities include site evaluation visits, feasibility surveys, initial applications to the IRB and other regulatory agencies, and internal quality control of regulatory document management. This position requires a high level of knowledge, oversight, and organization, and will serve as a central resource for faculty conducting clinical research. Responsibilities will also include orient and train research staff in the program, assist budget development and oversee overall study coordination, and support general operations of the program.


Specific Duties & Responsibilities

  • Work closely with Program Manager and PI’s to evaluate new concepts and complete pre-study regulatory requirements, including site selection visits, to ensure timely study submission and smooth activation.
  • Assist with protocol development and revision of investigator-initiated studies; assure protocols, amendments, consent forms, and study operation manuals have complete, consistent language throughout, including proper SAE reporting requirements, coordinating center requirements, etc.
  • Work closely with PI’s and sponsors to complete all new study submissions to the IRB, Center Cores, and other required regulatory documents.
  • Track each protocol through Urology and IRB approval process, evaluate for recurrent problems, develop and implement systems to decrease delay in the approval process.
  • For IND studies, maintain accurate and up-to-date documents and submissions.
  • For multicenter studies where Urology is the coordinating center, work closely with the project manager to collect and review regulatory documents from participating sites prior to study activation, attend study start-up meeting, maintain communication with sites to ensure high quality of data, timely submission of data, and adherence to guidelines.
  • Conduct internal quality assurance measures, including periodic monitoring and training sessions, to ensure all clinical research faculty and staff within the program are up-to-date with regulatory guidelines, standard operating procedures, and certification requirements.
  • Maintain a continued high level of expertise in institutional databases including Epic, CRMS, eIRB, using this proficiency to ensure accurate data and analysis are sustained for all trials within the program.
  • Support Program Manager with the full cycle of the protocol approval process – development, submission, contract negotiation, budget development, interaction with Center Cores.
  • Assist PI with abstracts and manuscripts preparation.
  • Assist Program Manager with program operations and staff orientation and training – providing suggestions for improved procedures, creating checklists and program-related standard operating procedures.
  • Participate as requested in Center initiatives such quality-improvement workgroups and committee meetings.
  • Complete minimum requirements for continuing education units. Maintain up-to-date knowledge of and comply with Good Clinical Practice, ICH Guidelines, and Urology Clinical Research Office policies.
  • Ensure that Center policies, standard operating procedures, and guidelines related to the conduct of clinical trials are followed.


Equipment, Machine, or Tool Requirements

  • General computer skills, with experience with Microsoft Office


Special Knowledge, Skills, or Abilities / Competencies

  • Highly effective verbal and written communication skills, and highly developed interpersonal skills required.
  • Must be able to independently assimilate and evaluate clinical and research data.
  • Must have working knowledge of IRB & FDA reporting requirements.
  • Knowledge of research methodology, clinical research practices and principles required.
  • Knowledge of medical terminology required.
  • Excellent organizational and time management skills required.
  • Excellent attention to detail skills required.
  • Proficiency in Microsoft Office, especially Word and Excel.


Specific Requirements

  • Must adhere to guidelines regarding honest reporting of sensitive and confidential patient information.
  • Understands 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.


Minimum Qualifications
  • Bachelors' Degree, preferably in health-related sciences. 
  • Five years' experience in clinical research at an academic, government, or pharmaceutical industry environment.
  • 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 experience to the extent permitted by the JHU equivalency formula.


Preferred Qualifications
  • Master’s Degree preferred.
  • Certification as a Clinical Research Professional is preferred.

 

 

Classified Title: Clinical Research Program Specialist 
Role/Level/Range: ACRP/04/MC  
Starting Salary Range: $48,000 - $84,100 Annually ($66,000 targeted; Commensurate with experience) 
Employee group: Full Time 
Schedule: Monday- Friday, 8:30 am-5 pm 
Exempt Status: Exempt 
Location: School of Medicine Campus 
Department name: ​​​​​​​SOM Uro Urology Research  
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.
School of Medicine - East Baltimore Campus

Apply now »