Sr. Clinical Research Manager; Plastic & Reconstructive Surgery

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.

• 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

• Bachelor s Degree in a related field.
• Six years of related experience in clinical research in an academic, government, or pharmaceutical industry environment.
• 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.

• Master s Degree in a related field.
• Certification as a Clinical Research Professional.

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/37.5 per week
FLSA Status:
Exempt

Location:

School of Medicine Campus
Department name: SOM Plastic Surgery
Personnel area:
School of Medicine