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
Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to learn but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130 years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses throughout the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are based at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Bal...timore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.
