Clinical Research Program Specialist

Johns Hopkins, founded in 1876, is America's first research university and home to nine world-class academic divisions working together as one university.

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

The successful candidate(s) for this position will be subject to a pre-employment background check.

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 HR Business Services Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.

The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.

During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.

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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