Academic Center Project Manager I - Clinical Events Committee HVTI

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Job Title
Academic Center Project Manager I - Clinical Events Committee HVTI

Location
Cleveland

Facility
Cleveland Clinic Main Campus

Department
HVTI Research and Registries-Main Campus Hospital

Job Code
T98809

Shift
Days

Schedule
8:00am-4:30pm

Job Summary

Job Details

Join the Cleveland Clinic team where you will work alongside passionate caregivers and make a lasting, meaningful impact on patient care. Here, you will receive endless support and appreciation while building a rewarding career with one of the most respected healthcare organizations in the world.

The Project Manager role participates in project management functions for single and multi-institutional research trials, including Phase I-IV clinical studies. You will coordinate and manage day-to-day organizational and operational aspects of trial conduct. This role provides central leadership by facilitating key communications across stakeholders, contributing clinical insight into trial design and implementation, and driving initiatives that ensure high-quality study conduct and performance. In this role you will collaborate with outside organizations, sponsors, CROs, physicians, internal staff, and C5 caregivers, while learning the full research lifecycle. Although not patient-facing, they play a critical role by collecting and reviewing source documents to determine whether clinical events occurred, then coordinating adjudication with study partners.

A caregiver in this position works 8:00am-4:30pm. Travel will be required!

A caregiver who excels in this role will:

• Collaborate with physicians, sponsors, and research teams to facilitate study planning, protocol development, and overall project execution in alignment with Cleveland Clinic standards.

• Analyze site strengths and weaknesses as they relate to the intended protocol and selection of qualified investigators/sites.

• Perform ongoing assessment of investigator/site performance.

• Develop or contribute to the performance standards to ensure the integrity of the study, quality of study conduct and study performance.

• Spearhead initiatives to improve quality and makes recommendations to discontinue site if necessary.

• Maintain professional relationships with sponsors, which includes frequent, open communication and associated documentation.

• Prepare and review study status reports.

• Act as a liaison between the Cleveland Clinic sites, sponsors, CRO or other vendors and the FDA.

• Act as the primary point of contact for the academic leadership committees and coordinate their activity including charter development to ensure successful conduct of the trial.

• Contribute to planned site communication and training (i.e., Investigator meetings, newsletters, study progress updates, telephone communication, supportive reinforcement of sponsor communication, etc.)

• Initiate and develop educational initiatives and tools.

• Maintain knowledge of the Code of Federal Regulations, ICH and GCP guidelines and their application to clinical research sufficient to train others.

• Other duties as assigned.

Minimum qualifications for the ideal future caregiver include:

• Associate's degree in general science or related medical field OR nursing degree/diploma

• A minimum of three years of clinical research experience or three years clinical experience.

• Demonstrated team, leadership, organizational and problem-solving abilities

Preferred qualifications for the ideal future caregiver include:

• Bachelor's degree

• RN/LPN License and previous research experience or previous cardiology or ICU nursing experience

• Certified Clinical Research Professional (CCRP) from the Society of Clinical Research Associates

• Certified Clinical Research Associate (CCRA)

• Certified Clinical Research Coordinator (CCRC)

• Certified Principal Investigator from the Association of Clinical Research Professionals

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Physical Requirements:

• Requires full range of motion, manual and finger dexterity and eye-hand coordination.
• Requires normal or corrected hearing and vision to normal range.
• Must be able to sit for long periods of time.

Personal Protective Equipment:

• Follows standard precautions using personal protective equipment

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