The employee will assume a position in the Division of Rheumatology as a Clinical Research Program Manager overseeing operational and regulatory aspects of clinical and translational research studies sponsored by pharmaceutical companies, government agencies, and Johns Hopkins investigators. Subject populations involved in the studies include various populations with rheumatic diseases and potentially healthy adults. The position is supervised by the Director of Research Operations and Director of the Rheumatic Diseases Research Core Center's Research Management and Patient Integrated Data Core Center.
Leads research and program efforts, directs the creation and management of new database systems, and implements reporting and quality assurance activities in the program using technical and decision making skills. Coordinate multiple elements of the clinical research program including study design, IRB interactions, data input, storage, retrieval and analysis; and interactions with investigators and other stakeholders. Recommends budget adjustments and other cost improvement measures.
The person in this position will:
Work on multiple complex clinical studies which require a high level of knowledge, coordination and data abstraction;
Maintain detailed knowledge of all assigned protocols, adhere to all protocol requirements to ensure the validity of the clinical research data, and transmit/distribute protocol information as needed;
Interact with faculty, fellows, and staff of various divisions and departments across the Johns Hopkins University School of Medicine.
Work closely with the Division's Administrative Core and the Division's HR Generalist to train and oversee research staff. The ability to work in a team environment is essential to this position.
The position is supervised by the Director of the Rheumatic Diseases Research Core Center's Research Management and Patient Integrated Data Core Center and Director of Research for the Division.
Works with the Clinical Director of the Division of Rheumatology, the Division of Rheumatology Assistant Administrator
Support hiring and onboarding of research staff
Essential Job Functions:
The person in this position will:
Serve as the initial point of contact for questions or concerns regarding clinical research (i.e., regulatory, contracting, and budgeting).
Works with divisional and institution grant resources to provide support for new submissions, progress reports, research information (i.e., equipment, facilities), invoicing and statistics.
Develop and maintain core resources for future grant activity
Assist senior management with strategic planning.
Develop and update divisional Standard Operating Procedures (SOP) for clinical and translational research related functions.
Develop a division-wide audit readiness plan and function as a primary resource for investigators in preparing for JHM IRB, Sponsor, and/or FDA audits and inspections.
Represent the division in interactions with sponsors and sponsor representatives (e.g., Contract Research Organizations (CRO)) in site qualification, site initiation, monitoring, and closeout visits ensuring compliance and providing timely responses.
Organize and lead regular meetings with research personnel in the division.
Represent research interests in divisional meetings (i.e., operations, executive)
Coordinate with management on human resources issues such as recruitment, employee relations, retention, and salary planning as impacted by budget constraints.
Take responsibility for completing tasks within specified timeframes.
Monitor IRB submissions, further study actions, and continuing review status of all research studies being conducted in the division.
Monitor a database to monitor and track mandatory research training compliance for all faculty, fellows, and staff.
Seek to ensure full compliance of the division to all research requirements.
Disseminate information, important dates, updates to policies and proprietary resource access through detailed written communication including updating websites.
Review and comment on the protocol, consent and budget all new studies ensuring scientific rigor, human subject protection and fiscal maintenance.
Protocol-specific Job Functions: The person in this position will have the knowledge to:
Complete and maintain up to date documentation of human subjects' research training required by the JHM IRB and protocol Sponsors including and not limited to: JHM Research Compliance, HIPAA, Bloodborne Pathogens, and CPR.
Attend and participate in staff and division meetings, protocol and research-related meetings and trainings, performance improvement and quality assurance activities, and other meetings as required or assigned.
Advise and assist multiple Investigators in conceptualizing data collection needs and translating these needs into collected data
Assist with developing plans for subject recruitment; advertising and recruitment materials, flyers, and other advertisements in newspapers, websites, or other venues as determined by study team.
Inform potential study subjects about research studies, procedures, and protocol requirements.
Explain the informed consent process to subjects, obtain, and document subject informed consent.
Conduct screening interviews and administer screening questionnaires.
Perform protocol-specific in-service training for research staff
Oversight of the order and inventory of clinical supplies necessary for performance of studies.
Oversight of the coordination for the subject study visits according to study protocol to include vital signs, ECGs, phlebotomy, and obtaining clinical samples.
Design and compile materials which aid physicians and other staff in complying with protocol requirements for these visits and tests.
Collect, compile, and maintain data in a research chart for each patient from a variety of sources.
Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
Monitor to confirm accuracy and timeliness of protocol procedures and data entries so that data information may be used for presentations and publication.
Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions.
Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about study issues.
Respond in a timely manner to special projects or queries related to the data.
Meet with the Principal Investigator to review data accuracy and overall study progress.
Communicate with clinical trial financial management staff as needed to identify procedures, laboratory tests and protocol events that require invoicing to the sponsor as defined in the financial contract.
Participate in relevant protocol, sponsor, and other meetings as required to remain current and increase knowledge of clinical trials.
Be willing and available for travel to research and study-related meetings if deemed necessary by the Principal Investigator.
Be available to work evenings and/or weekends per study requirements.
Additional duties may be required that are not yet identified.
Scope of Responsibility
Will have knowledge of the policies, procedures and practices necessary to conduct the work described above and an awareness of the role and importance of the position within the division.
Knows the informal and formal department goals, standards, policies and procedures which may include familiarity of other departments within the school/division. Is sensitive to the interrelationship of both people and functions within the Division and Department.
Will be responsible for own work.
Ability to work independently and be a proactive leader.
Demonstrate an ability to work well with a diverse professional team.
Exercise professional judgment and assume responsibility for own decisions, actions, results and consequences.
The person in this position will be expected to exchange complex and detailed information in an appropriate manner requiring strong oral and written communication skills.
The person in this position will be expected to have strong interpersonal skills.
Bachelor's degree in science or related field is required.
Five years related experience including significant experience conducting large research projects required.
Demonstrated knowledge of, and experience working in, various stages of the of Food and Drug Administration (FDA) drug approval process required
Experience with observational, interventional, investigator-initiated, and sponsored clinical trials highly desirable
Proficiency with Institutional Review Board (IRB) submissions and continuing reviews required
Accounting or budget experience required.
Advanced knowledge in the use of databases, spreadsheets, and/or word processing required (e.g., Word, Excel, Access, Power Point).
Proficiency with flowchart and organizational charts (e.g., Visio) highly desirable
Managerial experience and some statistical knowledge preferred.
Knowledgeable of and compliant with the Code of Federal Regulations Title 21-Good Clinical Practice Parts, 11, 50, 54, 56, and 312; with the International Conference on Harmonization Good Clinical Practice Guideline (E6); and with the policies and guidelines of the Johns Hopkins medicine IRB, and SOPs of the clinical trial sponsors.
Familiarity with Johns Hopkins clinical data structures is advantageous
Demonstrated organizational and time management skills with a high degree of attention to detail.
Project Management skills, experience and certification desired
Ability to manage multiple and competing priorities.
Must be able to maintain confidential information
Current CPR certification is preferred. If not current it is expected that the candidate will obtain CPR certification within the first 6 months of employment. Once obtained CPR ongoing certification is required.
Certification through SoCRA or ACRP is highly desired. If the applicant is currently certified through SoCRA or ACRP, then maintenance of certification, including all professional development activities, is required. If the applicant is not currently certified through SoCRA or ACRP than it is expected that the applicant will pursue certification. Once achieved then maintenance of certification, including all professional development activities, is required.
Sitting in a normal seated position for extended periods of time.
Work produced is subject to precise measures of quantity and quality.
Finger dexterity required to manipulate objects with fingers rather than with whole hand(s) or arm(s), for example, using a keyboard.
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 Baltimore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.