The Clinical Research Program Manager is responsible for the overall management of administrative, operational and functional components of multiple first in man studies in translational molecular imaging, early therapeutic nuclear medicine drug development, and imaging studies in therapeutic clinical trials. Will work with a group of scientists throughout JHU, regional universities, Pharma and government. Ensuring all clinical trials are conducted in accordance with federal, state, and local regulations, including GCP and IRB requirements and operations management, strategic planning and business development. Preparation and submission of IRB and FDA regulatory documents for new submissions, continuing reviews, amendments, Radiation Drug Research Committee (RDRC) Quarterly and RDRC /FDA Annual Reports. Accountable for regulatory and reporting compliance as well as monitoring/auditing to ensure compliance with governmental, institutional and private industry policies/procedures and in accordance with current Good Clinical Practices (cGCP) involving complex/multiple clinical research studies. Supervise and direct research assistants in execution of daily operations. Working independently on protocol design and data analysis.
Maintaining ongoing training and knowledge of current and upcoming regulations and guidance documents and troubleshoot/anticipate, often in advance, of potential problems and help create preventive, corrective and other strategic solutions. Review and writing of documents ensuring compliance with institution/corporate policies, federal regulations and guidelines and product development requirements/goals. Interaction with research scientists, institutional and corporate members, regulatory agencies, institutional review boards and other key members of cross functional teams, domestically and internationally Manage, strategize and implement projects to ensure completion documentation for timely and accurate submissions including coordination and strategizing (and making recommendations) to respond quickly and effectively with regulatory authorities including FDA Involved in Budgets/Contracts development.
Strategizing/creating/implementing of new policies and procedures. SAE reporting including IND Safety Reports to regulatory authorities including FDA. Corrective and Preventive Action Plan (CAPA) implementation and maintenance. Assist in R01 and T-32 Grant Application Submissions. Resource for Contracts/Budges Office(s). Human Subjects' Protection and Regulatory Affairs supervision/management of laboratory and clinical personnel - ensuring compliance, corrective and preventive plans of action to eliminate/mitigate research related errors, counseling of research personnel and implementation of corrective and disciplinary measures. Responsible for all aspects of regulatory submissions and the monitoring and auditing of all study-related documentation including protocols, consent forms, source documentation, CRFs, and other applicable research materials. Conduct of pre-IND FDA meetings and all research/regulatory related interdepartmental communications with Johns Hopkins as well as interactions with outside vendors, sponsors, CROs, NIH, FDA and other regulatory bodies. Lead Project Manager for protocol/study implementations from conception to close-out. Coordinate study regulation guidance with research interdepartmental research scientists to ensure regulatory compliance as well as NIH and other regulatory policies, laws and requirements including those of the Institutional Review Boards (IRB).
Submissions of all research/regulatory related documentation to the FDA, NIH, IRB, Sponsor and other applicable entities. Participate in the development of study design and writing of policies and procedures (SOPS). Creation of training documentation and conduct and documentation of training for various departments and personnel. Assist in writing and review of research protocols, consent forms and other research-related documentation. Preparation of FDA IND and RDRC Quarterly/Annual Reports. Quality Assurance and Quality Control duties. Supervisory capacity in ensuring all personnel including medical clinical staff person are within compliance of all scientific/medical research laws, regulations and applicable guidance documents. Prep and submission of IRB regulatory documents for new submissions, continuing reviews, amendments, and responses to IRB questions.
Bachelor's degree in related discipline.
Five years related experience. Demonstrated supervisory or lead responsibilities.
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.
Advanced Degree in related discipline. One year of management experience. Experience in clinical research and regulatory affairs. Experience in protocol and informed consent writing, data analysis, grant writing, and/or manuscript preparation. Knowledge of U.S and international related regulations. Knowledge of GCP, FDA and OHRP regulations. Experience with pharmaceutical and NIH sponsored research and familiarity with academic setting a plus. Certified Clinical Research Professional (CCRP) or Regulatory Affairs Certified (RAC) or other type of clinical research/regulatory certification.
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.