Bachelor's degree in Nursing, Science, Healthcare, or Computer Science with 3 years of clinical research experience, or equivalent
High School Diploma/GED with 7 years of experience, or
Associate's degree with 5 years of experience, or
Master's degree with 2 years of experience
Substantial scientific and medical knowledge in relevant therapeutic areas
Demonstrated ability to work with multiple software technologies
Knowledge of FDA regulations, GCPs, and internal SOPs
Responsibilities
Oversee administrative functions of research trials
Coordinate daily operations of Phase I-IV clinical trials
Facilitate communications for academic collaboration
Provide clinical perspective for trial design and conduct
Manage a clinical trials team for data analysis
Interact with Finance and Legal Departments for budget and contract execution
Maintain relationships with sponsors through open communication
Coordinate development and approval of research protocols and regulatory documents
Communicate with IRBs and FDA regarding protocol and safety issues
Organize and participate in Investigator Meetings and training programs
Develop communication plans with sites for updates and support
Analyze site strengths and weaknesses for protocol selection
Assess investigator and site performance
Lead quality improvement initiatives
Assist in developing recruitment strategies for research subjects
Benefits
Opportunity for a hybrid work schedule after initial onboarding period
Access to professional development and training programs
Engagement in cutting-edge pediatric research
Collaboration with a multidisciplinary team
Supportive work environment at a leading healthcare institution
Full Job Description
Job Title Clinical Research Project Manager - Pediatrics
Location Cleveland
Facility Cleveland Clinic Main Campus
Department RES Research Administration-Research Innov and Educ
Job Code T26213
Shift Days
Schedule 8:30am-5:00pm
Job Summary
Job Details
As a Clinical Research Project Manager, you will oversee the administrative functions of single- and multi-institutional research trials. In this role, you will coordinate and manage the daily operations and activities of Phase I-IV clinical research trials, facilitate key communications to support academic collaboration, and provide clinical perspective to the design and conduct of clinical trials.
A caregiver in this role works days from 8:30 a.m. - 5:00 p.m.
This position is fully onsite at Main Campus in Cleveland during the 3-6-month new-hire period.
After this period, there is an opportunity to transition to a hybrid schedule with 2-3 days per week remote. This position is not eligible for relocation assistance.
A caregiver who excels in this role will:
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 investigator 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.
Minimum qualifications for the ideal future caregiver include:
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
Complete training in Human Subjects Research (HSR) within 90 days or hire
Preferred qualifications for the ideal future caregiver include:
Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) Certification
Supervisory experience
Experience building budgets
Physical Requirements:
Requires full range of motion, manual and finger dexterity and eye-hand coordination.
Requires standing and walking for extensive periods of time.
Requires normal or corrected hearing and vision to normal range.
Personal Protective Equipment:
Follows standard precautions using personal protective equipment as required.
About Cleveland Clinic Foundation
The Cleveland Clinic Foundation is a non-profit academic medical center located in Cleveland, Ohio. It was founded in 1921 and has since become one of the largest and most respected hospitals in the world. The hospital is known for its innovative research and patient-centered care, and has been ranked as the #2 hospital in the United States by U.S. News & World Report. The Cleveland Clinic Foundation employs over 70,000 people and has locations throughout the United States and internationally. The hospital is also a major research institution, with over 3,000 active clinical trials and $1.5 billion in research funding.
