Inside Higher Ed · 1 day ago
Sr. Clinical Research Manager (Plastic & Reconstructive Surgery)
Baltimore, MD
Full-time
Onsite
Senior Level
$65K/yr - $113K/yr
6+ years expInside Higher Ed is seeking a Senior Clinical Research Manager to lead and oversee clinical research in Plastic & Reconstructive Surgery. The role involves collaborating with investigators, managing clinical research personnel, and ensuring compliance with research protocols and regulations.
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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
Qualification
Required
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
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
Preferred
Master's Degree in a related field
Certification as a Clinical Research Professional
Company
Inside Higher Ed
Inside Higher Ed is the online source for news, opinion, and jobs related to higher education.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2022-01-10Acquired
2006-08-31Series Unknown
Leadership Team
Stephanie Shweiki
Director, Foundation Partnerships
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