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. + Advanced knowledge of GCP/ICH and local regulations. + 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. + 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 + Regulatory Compliance
Advanced + Resource Management
Advanced + Strategic Program Management
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:

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Sr. Clinical Research Manager (Neurology) - #Staff