Clinical Research Project Manager - Grants & Contracts

Cleveland Clinic Nevada specializes in collaborative care, providing the community with ongoing care, clinical research and access to no-cost partner resources and education services. As a Clinical Research Project Manager, you will handle a variety of research-related projects supporting grants and contracts, focusing on advancing innovative treatments and overseeing administrative functions for research trials.

Responsibilities:

• Oversee the administrative functions of single and/or multi-institutional research trials
• Coordinate/manage daily organization and operational issues/activities related to Phase I-IV clinical research trials
• Facilitate key trial communications for academic coordination
• Provide clinical perspective to the design and conduct of clinical trials
• Manage and coordinate a clinical trials team (external industry team members, statisticians, database programmers and researchers) responsible for data accumulation, input and analysis
• Interact with the Finance and Legal Departments to facilitate clinical trial budget, site budget and contract execution
• Maintain professional relationships with sponsors, including frequent, open communication and associated documentation
• Coordinate development, preparation, review and approval of research protocols, case report forms and regulatory documents for the conduct of research required by Institutional Review Board (IRB), Sponsor and FDA
• Collect and review regulatory documents from sites
• Communicate with institutional and central IRBs, FDA and other parties regarding protocol subject and safety issues
• Organize, coordinate, attend and participate in Investigator Meetings and training programs
• Develop and maintain planned communication with sites (i.e., newsletters, study progress updates, telephone communication, supportive reinforcement of Sponsor communication, etc.)
• Analyze site strengths and weaknesses related to intended protocol and selection of qualified investigators and sites
• Assess investigators and site performance
• Lead initiatives to improve quality and make recommendations to discontinue sites if necessary
• Assist with the development, implementation and evaluation of research subject recruitment strategies, including marketing strategies, to maximize enrollment and retention
• Complete training in Human Subjects Research (HSR) within 90 days or hire

Requirements:

• Caregivers must reside in OH, FL or NV to be considered for this role
• Bachelor's Degree in Nursing, Science, Healthcare or Computer Science with an emphasis on programming and three years of clinical research experience as a Study Coordinator, Project Manager, Contract Research Associate or equivalent in a related field
• OR High School Diploma/GED and seven years of experience
• OR Associate's Degree and five years of experience
• OR Master's Degree and two years of experience
• Substantial scientific and medical knowledge across relevant therapeutic areas
• Demonstrated ability to work with multiple software technologies
• Knowledge of FDA regulations, GCPs and internal SOPs
• Knowledge of the Code of Federal Regulations, ICH and GCP guidelines and their applications to clinical research trials
• Background/ability or working with clinical studies and clinical research team members at all levels
• Within 90 days of hire, must successfully complete training in Human Subjects Research (HSR) as required by the Responsible Conduct of Research guidelines adopted by the Cleveland Clinic
• Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) Certification
• Supervisory experience
• Experience with submitting NIH grants and/or industry sponsored contracts