Under the direct supervision of the Principal Investigator, the Clinical Research Program Manager is responsible for monitoring and collecting research data in the Division of Hematology. The Clinical Research Program Manager is responsible for the organization, entry, maintenance and accuracy of all clinical research data for complex and detailed clinical trials, and may assist with orientation of less senior research staff in protocol and clinical research information. The Research Manager will be responsible for the coordination and implementation of assigned research projects within the research program and will anticipate research requirements for designated patient populations. The Research Program Manager may collaborate in development and writing of protocols and consent forms, in development and preparation of regulatory documents as appropriate and clarifying concerns and questions about new protocols with PI and Sponsor. This is an intermediate level position in managing research trials and registry databases within the research program.
Specific Duties & Responsibilities:
Oversee and conduct recruitment, screening and enrolling of eligible patients into clinical protocols.
Explain the protocol in detail and conduct informed consent procedures with potential research participants.
Maintain good working knowledge of all assigned protocols and reporting requirements. Work on complex clinical and research studies which require a high level of knowledge, coordination, and data abstraction.
Maintain regulatory binders for assigned protocols. Prepare and submit annual renewal requests, amendments and adverse event reports with clinical input according to IRB and Sponsor requirements. Adhere to all protocol requirements to ensure the validity of the clinical research data.
Assist the principal investigator and grant/program manager in defining information and plans required to accomplish goals of studies. Design and create protocol specific case report forms as needed. Assist less experienced staff in design and creation of such forms.
Verify patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements.
Collect, enter and compile clinical data from a variety of sources. Ensure accuracy and timeliness of data so that information may be used by the physicians in treatment planning for individual patients, and by the Principal Investigator in grant writings, presentations and publication.
Design and compile materials which aid physicians/other staff in complying with protocol requirements.
Meet regularly with Principal Investigator to review data accuracy and overall study progress. Participate in all mandatory meetings to develop increasing knowledge of assigned research and clinical trials.
Develop and maintain a protocol database or spreadsheet for tracking patient activity, data collection, and financial management. Participate in data analysis as needed.
Meet with department financial management staff to identify procedures, laboratory tests and protocol events that require invoicing to the Sponsor as defined in the financial contract. Participate in the development of invoicing schedules.
Complete minimum requirement for continuing educational units. Is knowledgeable of and complies with Good Clinical Practices, ICH Guidelines and Departmental Research Office policies. May instruct introductory level research personnel in these guidelines and policies.
Researches cost of medical procedures for clinical trials.
Negotiates research budgets with pharmaceutical companies.
Prepares contract application and internal budgets for contracts administration.
Acts as a liaison between pharmaceutical companies and the Department of Contracts Administration within the University.
Conducts contract reviews to ensure they are executed properly in terms of budget analysis.
Serves as central resource for clinical trials group, including the development of guidelines/templates for protocol development to ensure that all NIH, GCP, OHRP, JHU, and Federal regulations are followed in both the development and implementation of clinical trials.
Creating consent forms, preparing IRB regulatory submissions, initiating and supervising study regulatory files for all trials in the Division of Infectious Diseases, Johns Hopkins Rockland Physicians clinical trials group.
Prepares and submits advertisement and recruitment plan including radio, newspaper, flyers, local health events, and local associations pertaining to disease category and internal publications and/or web sites.
Functions as a liaison with the IRB and Clinical Research Office. Tracks each protocol through the IRB/subcommittee approval process, evaluates for recurrent problems, develops and implements systems to decrease delays in the trial approval, and intervenes as required to facilitate approval process.
Works with the research pharmacy with coordinating the dispensing of investigational drugs (if required).
Works with research pharmacy to coordinate study drug delivery and payment.
Ensures smooth implementation of new trials from initial contact through study activation.
Performs laboratory processing.
Participates in site development and start up meetings with sponsoring agencies as required.
Attends sponsor initiated investigator meetings as new studies begin.
Oversees submission of amendments and yearly protocol renewals. Plans and prepares for regular monitoring visits.
On occasion will prepare for and attend internal, sponsor, FDA, OSHA, OHRP or JCAHO inspections/audits. Preparation for these audits is very important.
Provides cost-benefit analysis of budgetary considerations and resource utilization issues.
Prepare invoices to sponsors accurately and in a timely manner.
Submit invoices to sponsors and work with divisional finance staff to reconcile accounts regularly ensuring no deficits in clinical trials accounts.
Collaborates with JHU based staff, investigators, regulatory bodies, and sponsoring organizations to resolve study-related needs.
Participates on conference calls with sponsor regarding status of clinical trials and site selection meetings.
Petty Cash Administrator.
Assists PI with protocol development, which may include writing informed consents. Initiate and/or maintain activities, systems and processes to increase
Referrals and increase accruals to multiple clinical trials. Trains and provides oversight of research data management and regulatory issues within the research program.
Development of Standard of Procedures (SOP)
Supervision of current research staff (problem solving, etc)
Training of new research staff
Bridge between research staff and others (PI, HR, clinical, etc)
Support for IRB for investigator initiated studies
Oversight of sponsored trial eligibility
Oversight of volunteer operations (assess need, assign volunteers)
Oversight of patient tracking
Perform all other duties as assigned.
Minimum Qualifications (mandatory):
Bachelor's degree required, preferably in health-related sciences.
Minimum of five years related experience required.
Experience with working and interacting with patients of at least one year required.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. 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.
Master's in relevant field preferred.
Special Knowledge, Skills, and Abilities:
Proficiency in the use of common software applications, databases, spreadsheets, and word processing required.
Excellent organizational skills required.
Excellent attention to detail skills required.
Must have ability to manage multiple and competing priorities.
Must have excellent time management skills.
Must have excellent oral and written communication skills.
Must be able to work independently.
The successful applicant will demonstrate an ability to work well with other professionals with minimal supervision, and be comfortable being part of a diverse professional team.
Research staff at both Johns Hopkins East Baltimore and Johns Hopkins Bayview campuses.
Classified Title: Clinical Research Program Manager Working Title: Clinical Research Program Manager Role/Level/Range: ACRP/04/MD Starting Salary Range: $52,495-$72,210; commensurate with experience Employee group: Full Time Schedule: Monday-Friday/8:30am-5:00pm Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10002811-SOM DOM Hematology Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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