Schedule (hours/days): 37.5 hours per week; Monday-Friday
Location: East Baltimore Campus
Under the direction of the Division Director, the Research Manager will be responsible for overseeing the research operations of the Multiple Sclerosis Center in the Department of Neurology. The Research Program Manager will provide the division leadership with an overarching view of the status of the division's MS research activities in order to assist in the development of funding acquisition strategies, budget planning and the effective utilization of divisional resources. The Research Program Manager will oversee a portfolio of currently approximately 30 clinical research studies and manage a coordinator and administrative staff of 10. Be a resource for research nurses and postdocs.
Specific duties & responsibilities:
Programmatic: Assist the division PIs in achieving the research goals outlined in grant protocols and set by the funding agencies and in setting program priorities. Participate in the development and adaptation of program protocols and staffing resources over time to meet divisional priorities. Oversee the development of data collection instruments, protocols, organizational plans, and operating procedure manuals. Assist in the preparation of annual sponsor progress reports and grant renewal submissions.
Regulatory: Assist the division PIs in overseeing and maintaining institutional and federal regulatory compliance, including preparing IND applications to the FDA, FDA annual reports, annual IRB continuing reviews, changes in research, and adverse events reports according to IRB and sponsor requirements, and facilitating IRB audits. Ensure that investigations are conducted according to ICH-GCP guidelines. Assist in the preparation of Material Transfer Agreements and other contractual documents. Maintain accurate and up-to-date regulatory documentation, including evidence of investigator qualifications, staff training compliance, laboratory licensing and accreditation, delegation of authority, and IRB-related documentation.
Data Collection: Provide broad oversight of the recruitment and enrollment of study participants into the various studies and trials in the division. Serve as a back-up neuropsychological examiner as needed during in-person participant assessments. Advise on neuropsychological test administration and scoring issues. Serve as a back-up staff to assist in the collection, processing, storage and shipment of bio specimens.
Data Management: Oversee the management of all research data, including the design, creation and maintenance of study databases and participant records. Use CRMS and EPIC to track participant enrollment and clinical laboratory results as needed. Oversee the design and maintenance of the division's REDCap databases. Oversee and facilitate the sharing of clinical data and bio specimens with program collaborators. Work with sponsors to develop and implement the sponsor-specific data collection protocols and protocols for the sharing of clinical data and bio specimens. Oversee the physical and electronic storage of participant charts. Work with IT staff to maintain restricted-access data-sharing folders on the department server, and to ensure compliance with university policies regarding encryption of electronic devices.
Scientific: Participate in the development and implementation of study protocols, including the design and compilation of data collection forms and cognitive testing measures in accordance with the scientific research goals of the program. Coordinate and participate in monthly meetings focused on the formulation of research questions and hypotheses, the use of existing data to answer those questions and planning of scientific reports and publications. Independently extract data, conduct preliminary statistical analyses, review literature, and participate in the preparation of manuscripts and posters for presentation.
Personnel: Assist division PIs in the hiring and supervision of staff members and provide day-to-day coaching and disciplinary guidance as needed. Assist as needed in the training of study staff (and cross-training of division staff) on the implementation of study protocols, including the administration of structured interviews, neuropsychological testing batteries, and collection and storage of bio specimens. Serve as needed as a contact person for individuals applying for employment or internship opportunities with the division. Participate in the interviewing and hiring process of new staff members, including research nurses, postdocs, and students.
Administrative: Train staff to independently process and track incoming invoices, employee reimbursements, and participant remunerations. Oversee the purchasing and management of divisional research supplies. Work directly with senior administrative-financial staff to support the division PIs in budget planning and monitoring.
Minimum qualifications (mandatory):
Bachelor's degree in related discipline and five (5) years related research or work experience in program management or research required. Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
JHU Equivalency Formula: 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 Degree in related field
Special knowledge, skills, and abilities:
Excellent organizational skills required
Excellent attention to detail skills required
Knowledge of medical terminology required
Familiar with medical procedure and laboratory fees
Ability to manage multiple and competing priorities
Knowledge of clinical research practices and principles required
Ability to understand a clinical trial financial contract
Must have excellent time management skills
Must have excellent oral and written communication skills
Ability to work in a team and demonstrated interpersonal skills
Ten employees; Research Program Coordinators/Sr. Research Program Coordinators and Program Administrator
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.