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The Department of Neurology is seeking a Sr. Clinical Research Manager for the BIOS Clinical Trials Coordinating Center (CTCC). Researchers at Johns Hopkins University conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. The Sr. Clinical Research Manager works in collaboration with PI(s) to set the direction for research and is responsible for the overall management of a clinical trials portfolio and clinical research activities. Plans and directs clinical research operations which typically involves external partners and internal collaborators, and/or national and international networks. Responsible for managing research staff, developing and implementing effective data management and regulatory procedures, providing education to research staff, and ensuring research staff are properly trained.
Specific Duties & Responsibilities
- Collaborate with investigator(s) and exercise independent judgement in directing the conduct of the research.
- Participate in scientific discussions with collaborators, PI's, and funding organizations and contribute to decisions impacting conduct of research.
- Responsible for the recruitment, education, training and supervision of the clinical research coordinators and regulatory personnel within the program.
- Responsible for development and implementation of policy and procedures for clinical research within the program.
- Facilitate effective teamwork among all involved personnel, e.g. research staff, research nursing, data management, regulatory personnel, hospital staff, etc.
- Ensure responsible conduct of clinical research protocols throughout the lifecycle, including development, implementation, maintenance, and termination.
- Collaborate with PIs on research protocol development and evaluation, including reviewing and assessing new protocols for clarity, thoroughness, financial and logistical feasibility, maintaining subject safety etc.
- Oversee preparation and submissions to IRB and act as liaison for regulatory issues on behalf of the PI.
- Track and oversee the regulatory approval process to ensure efficient study startup; assist regulatory staff with informed consent and protocol amendments for investigator-initiated studies
- Manage clinical research budget generation and financial management of the program.
- Ensure efficient use of centralized resources and adherence to policies as appropriate, e.g. clinical trial management system, prospective reimbursement analysis, etc.
- Analyze resource utilization by individual trials to ensure research needs are anticipated and met.
- Ensure adequate system for tracking and reporting clinical research milestones for financial invoicing.
- Ensure the development, testing, and evaluation of manuals, questionnaires, and coding structures for the efficient collection of data.
- Ensure research staff maintain complete and accurate research data and charts and are well prepared for auditing and monitoring visits.
- Lead study meetings to examine data, decide on next steps, implement changes to protocol operations based on results and goals, and initiate sub-studies.
- Contribute to manuscripts and presentations.
- Other duties as assigned.
Minimum Qualifications
- Bachelor's Degree in a related field.
- Six years of related experience in clinical research in an academic, government, or pharmaceutical industry environment.
- Demonstrated supervisory or lead experience.
- Additional education may substitute for required experience and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.
Preferred Qualifications
- Master's Degree in a related field.
- Certification as a Clinical Research Professional.
- Advanced knowledge of GCP/ICH and local regulations.
- Formal project management training or certification.
Technical Skills & Expected Level of Proficiency
- Budget Management - Advanced
- Clinical Resource Knowledge - Advanced
- Data Management and Analysis - Advanced
- Good Clinical Practices - Advanced
- Finance Project Management - Advanced
- Oral and Written Communications - Advanced
- Program Development - Advanced
- Record Keeping - Advanced
The core technical skills listed are most essential; additional technical skills may be required based on specific division or department needs.
Classified Title: Sr. Clinical Research Manager
Role/Level/Range: ACRP/04/ME
Starting Salary Range: $64,600 - $113,300 Annually ($89,000 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: M-F 8:30 am - 5:00 pm
FLSA Status: Exempt
Location: Remote
Department name: SOM Neuro BIOS
Personnel area: School of Medicine
