"Alerted.org

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 1-2 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

Our caregivers continue to create the best outcomes for our patients across each of our facilities. Click the link and see how we're dedicated to providing what matters most to you: https://jobs.clevelandclinic.org/benefits-2/

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.

Pay Range

Salaries [which may be] shown on independent job search websites reflect various market averages and do not represent information obtained directly from The Cleveland Clinic. Because we value each individual candidate, we invite and encourage each candidate to discuss salary/hourly specifics during the application and hiring process.

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