Clinical Research Project Manager NE - HVTI Research & Registries

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Job Title
Clinical Research Project Manager NE - HVTI Research & Registries

Location
Cleveland

Facility
Cleveland Clinic Main Campus

Department
HVTI Research and Registries-Heart Vascular & Thoracic Institute

Job Code
D99704

Shift
Days

Schedule
8:00am-5:30am

Job Summary

Job Details

Join Cleveland Clinic's Main Campus where research and surgery are advanced, technology is leading-edge, patient care is world class and caregivers are family. Here, you will work alongside a passionate and dedicated team, receive endless support and appreciation, and build a rewarding career with one of the most respected healthcare organizations in the world.

This role manages the full administrative and operational lifecycle of Phase I-IV clinical research trials. Acting as a central coordinator, the position ensures seamless communication and collaboration among investigators, sponsors, regulatory bodies, and internal teams. A critical part of the role is guiding physicians in protocol development and ensuring regulatory compliance, especially given that many clinicians lack in-depth regulatory knowledge. You interact with physicians and investigators, clinical trial sponsors, clinical research team members, regulatory bodies (IRB and FDA), other internal departments and external research sites.

The position requires managing several concurrent studies (typically 4-5), which may vary in length from a few months to over a decade (especially for device trials).

Responsibilities also include site selection, performance assessment, and recommending continuation or termination of site participation based on quality. The project manager plays a vital role in protocol review and site monitoring coordination. Experience in cardiovascular research (particularly within the HVTI network) is valuable, and international collaboration is part of the role, including work with physicians in Abu Dhabi.

A caregiver in this position works part-time, 4 days per week from 8:00am-5:00pm. (M-F) Day off during the week can be flexible.

A caregiver who excels in this role will:

• 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 Sponsor 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.

• Assesse investigator and site performance.

• Lead initiative to improve quality and makes recommendation to discontinue site if necessary.

• May assist with the development, implementation and evaluation of research subject recruitment strategies, including marketing strategies, to maximize enrollment and retention.

• Perform other duties as assigned.

Minimum qualifications for the ideal future caregiver include:

• Bachelor's degree in nursing, general science, a health care discipline or computer science with programming emphasis

• 3 years clinical research experience as a Study Coordinator, Project Manager, Contract Research Associate or equivalent management experience in a related field

• OR Associate's Degree and 5 years of experience

• OR Master's Degree and 2 years of experience

• Excellent interpersonal, organizational and project management skills

• 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 Code of Federal Regulations, ICH and GCP guidelines and their applications to clinical research trials

• 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

• Demonstrated background/ability or working with clinical studies and clinical research team members at all levels

Preferred qualifications for the ideal future caregiver include:

• Supervisor experience desirable

• Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) Certification desirable

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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 follwed 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