Academic Center Project Manager I - Clinical Events Committee HVTI

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

• Two years of clinical research 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

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.