Clinical Research Program Specialist

We are seeking aClinical Research Program Specialistwho will serve as a central resource for the Gynecologic Oncology faculty conducting clinical research at Johns Hopkins University and across multiple clinical trial sites. This position will serve as Lead Specialist for Break Through Cancer (BTC) grant PIs for coordination and management of communications work with external entities such as Greater Than One (GTO), coordination and management of clinical studies with JHU and 4 collaborating sites, MTA & DUA submissions, revisions to Scope of Work and other BTC related reports for the team lab, IRB submissions and similar tasks. Specifically, the position entails providing complex project support to the faculty including assistance with grant applications and progress reports, translational research protocols and important correspondence, and project management particularly of communications work with GTO and others. This position will also be responsible for obtaining and updating Institutional Review Board (IRB) approval for biospecimen and clinical data transfer requests with our collaborators under BTC and for other projects within our program. This includes the development of laboratory manuals and the design of biospecimen databases, providing complex project support to the faculty including assistance with writing papers, reviews, grants, translational research protocols and important correspondence, copy editing and project management. This person will deal regularly with highly sensitive, privileged and confidential subject matter.

Specific Duties & Responsibilities

• Work closely with the Principal Investigators on studies to ensure timely, accurate submission to the IRB for biospecimen and data transfer applications.
• Assure biospecimen and data transfer protocols have complete, consistent language throughout. Follow up the status and identify the bottleneck in the approval processes.
• Obtain all required documents for biospecimen and data transfer submissions to the IRB.
• Tracks each protocol through the IRB/subcommittee approval process, evaluates for recurrent problems, develops and implements systems to decrease delay in the approval process.
• Develop and maintain study documents such as laboratory manuals.
• Internally monitor regulatory files and study data to assess compliance, data quality, and accuracy.
• Complete IRB amendment submissions and ensure documentation of training.
• Attend study start up meeting for studies including those where SKCCC is the coordinating center.
• Participate in site initiation visits for studies where Hopkins is the Coordinating Center and Cancer Center investigator is the Lead or Protocol Chair.
• Produce and maintain a regulatory binder prior to study starting with all required documents.
• Work closely with Principal Investigators to ensure all documents are reviewed, approved and correct prior and during the study.
• Ensure all documents are being collected in a timely manner and all regulatory binders are up to date.
• Assist with study monitoring/auditing requirements.
• Develop standard operating procedures for regulatory submissions as needed.
• Maintain a continued high level of expertise in institutional databases including REDCap, OpenSpecimen, EPIC, CRMS, eIRB, using this proficiency to ensure accurate data and analysis are sustained for all trials within the program.
• Review and analyze studies for difficulties that may arise with study processes and procedures. Suggest appropriate alternatives to possible complications.
• Complete minimum requirements for continuing education units. Maintain up to date knowledge of and comply with Good Clinical Practice, ICH Guidelines, and SKCCC Clinical Research Office policies. Teaches staff about regulatory aspects.
• Updates faculty on regulatory study status.
• Providing complex project support to the faculty including assistance with grant application and progress report, translational research protocols and important correspondence, and project management. This person will deal regularly with highly sensitive, privileged and confidential subject matter.
• Edits presentations.
• Coordinate and manage communications work with internal and external entities such as Armstrong Institute, Greater Than One and others.

Special Knowledge, Skills & Abilities

• Knowledge of clinical research practices and principles.
  
• Highly effective verbal and written communication skills, and highly developed interpersonal skills.
  
• Must be able to independently assimilate and evaluate clinical data.
  
• Proficiency in Microsoft Office, especially Excel and Word, and a working knowledge of Access or other clinical databases.
  
• Must be familiar with medical terminology. Must be experienced in handling multiple tasks at once and working well as a member of a team.
  
• Must have working knowledge of FDA reporting requirements.
  
• Excellent organizational skills.
  
• Excellent attention to detail.
  
• Must have excellent prioritization skills.
  
• Must have familiarity with NIH, GCP, and federal regulations for human subject participation in clinical research.
  
• Ability to handle multiple and competing priorities.
  
• Ability to interact appropriately and productively with staff at all levels.
  
• Must have excellent time management skills.
  
• Ideally has had experience serving in project management role in the past.

• Bachelors' Degree.
• 5 years experience in clinical research at an academic, government, or pharmaceutical industry environment.
• Experience in clinical research and regulatory affairs.
• Experience in protocol and informed consent writing, data analysis, grant writing, and /or manuscript preparation.
• Additional education may substitute for experience to the extent permitted by the JHU equivalency formula.
• Knowledge of research methodology and working knowledge of computers.

• Bachelor's Degree in Biological/Social Sciences.
• Master's Degree.
• Experience in budget generation, contractual process and financial management of clinical trials.

Classified Title: Clinical Research Program Specialist
Role/Level/Range: ACRP/04/MC
Starting Salary Range: Min $47,500 - Max $83,300 Annually ($65,400 targeted; Commensurate with experience)
Employee group: Full Time
Schedule: Monday - Friday, 8:30 am - 5:00 pm
Exempt Status:Exempt
Location:School of Medicine Campus
Department name: SOM OB GYN Gynecologic Oncology
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:

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.

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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.

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Accommodation Information

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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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