The Clinical Research Program Administrator provides clinical trial support to leadership and investigators in the Neurofibromatosis Therapeutic Acceleration Program (NTAP) and the Comprehensive Neurofibromatosis Center at Johns Hopkins University School of Medicine. NTAP is a philanthropically funded research organization focused on developing effective therapies for plexiform and cutaneous neurofibromas, the two most common tumors afflicting patients with Neurofibromatosis Type 1 (NF1). Both NTAP and Comprehensive Neurofibromatosis Center are within the Department of Neurology in the Johns Hopkins University School of Medicine. NTAP uses a highly collaborative approach that brings together patients, clinicians, researchers, industry, and government to develop and deploy resources to produce meaningful treatments for plexiform and cutaneous neurofibromas in people with NF1.
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 NTAP, the Comprehensive NF Center, 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 NTAP Executive Director and the Director of Clinical Research.
Specific Duties & Responsibilities
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 NTAP 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 and set by the . 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: Potentially 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 NTAP 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 five 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.
Additional education (graduate level) 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. *
PhD in related field
Special Knowledge, Skills, and Abilities
The successful candidate should be able to operate independently, with guidance provided by NTAP leadership and 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/04/MF Starting Salary Range: $70,805 - $97,435: commensurate with experience Employee group: Full Time Schedule: Monday-Friday, 8:30 am - 5:00 pm, 37.5 hours/week Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10003523-SOM Neuro Neurological Oncology Personnel area: School of Medicine
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