The Clinical Research Program Administrator provides clinical trial support to leadership and investigators in the Heart failure with preserved ejection fraction Program (HFpEF) at Johns Hopkins University School of Medicine. The HFpEF program and its associated clinical trials and NIH or AHA funded grants are focused on treatments and mechanistic studies in patients with heart failure with a preserved ejection fraction.
Responsibilities including but not limited to generating protocols, generating and maintaining addendum of protocols, creating and ensuring compliance with the necessary regulatory documents and oversight plan for individual studies, coordinating the program's clinical research studies, overseeing and coordinating data collection and management, facilitating information exchange between HFpEF, outside institutions and investigators, regulatory agencies within and outside of Johns Hopkins, and funders. Other duties include generating reports, presentation of individual and global progress in clinical research studies, coordination of meetings with new collaborators, assistance with completing necessary contracting for clinical research studies, general oversight of research associated spending. This position reports to the Director of the Johns Hopkins Heart Failure with Preserved Ejection Fraction. The position will also support the PI who is the National Leader of multiple multi-center, US-based and international clinical trials in HFpEF that are industry sponsored (clinical trials enrolling at over 70+ US centers and international centers). This role may include attendance at national leader meetings, assistance with communication and patient screening and enrollment tips at other sites involved in these studies. This individual will also be involved in developing the HFpEF clinical program research protocols, and database development. Over time, this position may support other providers within the Heart Failure section in similar responsibilities depending on the number of ongoing studies in the HFpEF program, and the clinical research needs of the group.
Scientific: Manage the development and implementation of study protocols, including assist with the writing, maintenance and updates of clinical research protocols and the design and generation of case report forms and the compilation of data collection and management. Coordinate and participate in meetings focused on the formulation of clinical research questions and hypotheses, the use of existing data to answer those questions and planning of scientific reports and publications. Independently extract data, review literature, and participate in the preparation of manuscripts and posters for presentation.
Regulatory: As part of the team, collaborate with faculty, develop and maintain updates of clinical research protocols, develop SOP, and supervise study-related activities for multiple clinical studies. With the HFpEF leadership, oversees and maintains 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 required to execute clinical research projects. 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 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 research studies' REDCap databases. Oversee and facilitate the sharing of clinical data and biospecimens 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 biospecimens. 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.
Programmatic: Work with the principal investigators and research team (internal and external to JHU) in achieving the research goals outlined in grant protocols. Participate in the development and adaptation of program protocols and staffing resources over time to meet priorities. Oversee the development of data collection instruments, protocols, organizational plans, and operating procedure manuals to support successful completion of clinical research studies. Assist in the preparation of annual sponsor progress reports, grant submissions and manuscript and presentation preparation.
Data Collection: Provide broad oversight of the recruitment and enrollment of study participants into the various studies and trials in the division. Assist in the collection, processing, storage and shipment of biospecimens and the collection, processing and secure data management of data generated in clinical research initiatives.
Personnel: Responsible for 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 (lead site initiations). . 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. Lead efforts to train and ensure compliance of external investigators with HFpEF sponsored clinical research.
Administrative: 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 budget planning and monitoring for clinical research expenses. Ensure compliance with protocol spending and payments according to prospective reimbursement plans.
Requires Master's Degree in health-related sciences, and a minimum of eight years of experience in clinical research at an academic, government, or pharmaceutical industry environment.
Extensive experience with clinical research sciences, regulatory affairs.
Extensive experience with protocol and informed consent writing, data use agreements, data analysis, grant writing, and manuscript preparation and production required.
Special Knowledge, Skills, and Abilities:
The successful candidate should bxe able to operate independently, with guidance provided by PIs. The candidate will have background and experience in the conduction of clinical research, research ethics, regulatory compliance, use of centralized IRBs and master agreements, and project management at the task level.
This position requires adherence to strict regulatory requirements and timelines. Building and maintaining strong, trusting relationships is critical. The successful candidate will have experience presenting to investigative teams, end-users (faculty and staff), and subject matter experts and must possess excellent facilitation, and consensus-building skills.
Ability to prioritize own work and work of others as needed. Ability to work with flexibility on several tasks simultaneously and to meet various concurrent deadlines. Very strong organizational skills, analytical and problem-solving abilities and attention to detail.
Demonstrated ability to coordinate projects independently and work constructively as part of a team. Ability to maintain confidentiality. Strong interpersonal and communication skills, both oral and written.
Classified title: Project Administrator
Working title: Clinical Research Program Administrator
Role/Level/Range: ACRP 37.5/E/04/MF
Starting Salary Range: $70,805.04 - $97,437.60 (commensurate with experience)
Employee group: Fulltime
Employee Status: Exempt
Schedule: Monday-Friday –8:30am-5:00pm 37.5hrs/Wk
Location: 600 N Wolfe St., Baltimore, MD
Department name: 10002805-SOM DOM Cardiology
Personnel area (School): SOM – 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 email@example.com. 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 Employer Note: Job Postings are updated daily and remain online until filled.
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.