Clinical Research Project Manager

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At Cleveland Clinic Health System, we believe in a better future for healthcare. And each of us is responsible for honoring our commitment to excellence, pushing the boundaries and transforming the patient experience, every day.

Job Title

Clinical Research Project Manager

Location

Cleveland

Facility

Cleveland Clinic Main Campus

Department

Research Administration-Research Innov and Educ

Shift

Days

Schedule

8:00am-4:30pm

The Cleveland Clinic's Research and Innovation and Education Institute is a core component of the institution's mission, focused on advancing medical knowledge and patient care through research, education, and translating scientific discoveries into practical applications. This institute includes various centers and programs such as the Lerner Research Institute, Cleveland Clinic Innovations, and the Education Institute, all working together to improve healthcare outcomes. Here, you will work alongside passionate and dedicated caregivers, receive endless support and appreciation and build a rewarding career.

As a Clinical Research Project Manager, you will begin by focusing on grants management and financial oversight. This position includes supervision of two external sites, management of a single IRB, and preparation of progress reports. You will handle various research-related projects within your assigned department, performing the "behind-the-scenes" work necessary to support innovative treatments. In this role, you will collaborate with fellow researchers and clinical caregivers, contribute to budget and contract management, monitor patient visits, and provide operational perspective to ensure research projects run smoothly.

This position offers continued learning and growth, all while allowing you to not only make a difference in Cleveland but potentially the world.

A caregiver in this position works days from 8:00 a.m. 4:30 p.m.

This is a hybrid role after the new-hire period, with the opportunity to work from home 12 days per week.

A caregiver who excels in this role will:

• Oversee the administrative functions of single and/or multi-institutional research trials.
• Coordinate and 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 of 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

Preferred qualifications for the ideal future caregiver include:

• Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) Certification
• Supervisory experience
• IRB experience
• Understanding of Clinical Research

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.

The policy of Cleveland Clinic Health System and its system hospitals (Cleveland Clinic Health System) is to provide equal opportunity to all of our caregivers and applicants for employment in our tobacco free and drug free environment. All offers of employment are followed by testing for controlled substance and nicotine. All offers of employment are followed by testing for controlled substances and nicotine. All new caregivers must clear a nicotine test within their 90-day new hire period. Candidates for employment who are impacted by Cleveland Clinic Health System's Smoking Policy will be permitted to reapply for open positions after one year.

Cleveland Clinic Health System administers an influenza prevention program. You will be required to comply with this program, which will include obtaining an influenza vaccination on an annual basis or obtaining an approved exemption.

Decisions concerning employment, transfers and promotions are made upon the basis of the best qualified candidate without regard to color, race, religion, national origin, age, sex, sexual orientation, marital status, ancestry, status as a disabled or Vietnam era veteran or any other characteristic protected by law. Information provided on this application may be shared with any Cleveland Clinic Health System facility.

Please review the Equal Employment Opportunity poster.

Cleveland Clinic Health System is pleased to be an equal employment employer: Women / Minorities / Veterans / Individuals with Disabilities