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Posted: Saturday, February 17, 2018 7:57 AM

The Department of Oncology is currently seeking a Multicenter Clinical Trial Specialist. Under limited supervision of the Clinical Research Program Manager, the person in this role is responsible for study site activation and management, including regulatory review, site study team training, data monitoring and integrity management, patient enrollment, and overall project timeline management for the Genitourinary Oncology Clinical Research Program. This 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 and assist with general operations of the program. DUTIES AND RESPONSIBILITIES Coordinate the conduct of multicenter clinical trial protocols, including study site selection and activation, patient enrollment, electronic case report form design, specimen shipping, data monitoring, safety review, and other protocol-related tasks. Assist with protocol development and revision of investigator-initiated multicenter studies: Assure protocols, amendments, consent forms, and study operation manuals have complete, consistent language throughout, including proper SAE reporting requirements, coordinating center requirements, etc. Track each site through local regulatory review and contract execution process, evaluate for recurrent problems, development and implement systems to decrease delay in site activation process. Collect and review regulatory documents from participating sites prior to study activation, conduct study start-up meetings, maintain communication with sites to ensure high quality of data, timely submission of data, and adherence to guidelines. Review subject eligibility and registration request. Conduct on-site training and monitoring visits as needed. For IND studies, maintain accurate and up-to-date documents and submissions. Facilitate the full cycle of the protocol approval process - development, submission, contract negotiation, budget development, interaction with Cancer Center Cores. Assist PI with abstracts and manuscripts preparation. When needed, recruit and train research data management and regulatory personnel within the Program. 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. Assist Clinical Research Program Manager with program operations - providing suggestions for improved procedures, creating checklists and program-related Standard Operating Procedures. Participate as requested in Cancer Center events such as training and orientation for new research staff, testing of CRMS database updates and modules. 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. Ensure that Cancer Center policies, Standard Operating Procedures, and guidelines related to the conduct of clinical trials are followed. Qualifications: Bachelor's degree in Biological/Social/Health Sciences and Five years of experience in clinical research at an academic, government, or pharmaceutical industry environment Required. Additional education may substitute for some required experience, to the extent permitted by the JHU Equivalency Formula. Experience in clinical research and regulatory affairs required. Experience in protocol and informed consent writing, data analysis, grant writing, and /or manuscript preparation required. Must have effective verbal and written communication skills, and highly developed interpersonal skills and be able to independently assimilate and evaluate clinical data. Must be proficient in Microsoft Office, especially Excel and Word, and a working knowledge of Access or other relational databases and be familiar with medical terminology. Must have working knowledge of FDA reporting requirements, be experienced in handling multiple tasks at once, and working well as a member of a team and must have working knowledge of FDA reporting requirements. JHU Equivalency Formula: 18 graduate degree credits may substitute for one year of experience. Preferred: Master's in relevant field preferred. Two years of experience in clinical trial and or clinical research in a patient setting. Experience in budget generation, contractual process and financial management of clinical trials preferred. Classified Title: Clinical Research Program Specialist Rolel/Level/Range: ACRP/4/MC Salary: $43,871 - $60,402 Status: Full-Time Department: Oncology Work Hours/Schedule: Monday-Friday/8:30-5:00pm/37.5 Location: East Baltimore Campus 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 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. Equal Opportunity EmployerNote: Job Postings are updated daily and remain online until filled. EEO is the LawLearn more: legal information Facility School of Medicine - East Baltimore Campus Personnel Area School of Medicine

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Company: Johns Hopkins University

• Location: Baltimore

• Post ID: 30887357 baltimore is an interactive computer service that enables access by multiple users and should not be treated as the publisher or speaker of any information provided by another information content provider. © 2018