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Job Title
Academic Center Project Manager I
Location
Cleveland
Facility
Cleveland Clinic Main Campus
Department
Transplant Center-Heart Vascular & Thoracic Institute
Job Code
T98809
Shift
Days
Schedule
8:00am-4:30am
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.
As an Academic Center Project Manager I, you will support the management of single- and multi-institutional research trials, including coordinating day-to-day operations and activities for Phase I–IV clinical research studies. In this role, you will facilitate trial communications and academic collaboration, provide clinical perspective on trial design and conduct, and lead initiatives to ensure study quality and performance. You will also support Clinical Events Committee (CEC) activities by providing independent, blinded determinations of clinical trial endpoints and events, which are critical to the acceptance of trial results by regulatory authorities, academic leaders, and medical communities. Although the role does not involve direct patient care, you will review source documentation to determine whether clinical events have occurred and coordinate the adjudication process with study partners, primarily focusing on cardiovascular endpoints.
A caregiver in this role works Monday through Friday from 8:00 a.m. – 4:30 p.m., with travel required.
After 90 days, the position offers a hybrid schedule with two days onsite, and three days remote per week.
A caregiver who excels in this role will:
- Coordinate and contribute to protocol development and review by evaluating clinical and regulatory considerations related to the diagnosis and treatment of study subjects, current clinical practices, and experience with similar protocols.
- Analyze site strengths and weaknesses to support the selection of qualified investigators and study sites.
- Conduct ongoing assessments of investigator and site performance.
- Develop performance standards to ensure study integrity, quality of conduct, and overall study performance.
- Lead quality improvement initiatives and recommend site discontinuation when necessary.
- Maintain professional relationships with sponsors through frequent, open communication and thorough documentation.
- Prepare and review study status reports.
- Serve as a liaison among Cleveland Clinic sites, sponsors, contract research organizations (CROs), other vendors, and the U.S. Food and Drug Administration (FDA).
- Serve as the primary point of contact for academic leadership committees and coordinate their activities, including charter development, to support successful trial conduct.
- Coordinate site communications and training, including investigator meetings, newsletters, study progress updates, and telephone communications.
- Develop educational initiatives, tools, and training materials to support study teams and collaborators.
- Establish processes for timely event adjudication.
- Develop Clinical Events Committee (CEC) charters and endpoint definitions.
- Identify Medical Dictionary for Regulatory Activities (MedDRA) and adverse event terms for event identification.
- Train adjudicators and develop Electronic Adjudication System (EAS) workflows.
- Implement study-specific quality assurance plans.
- Maintain knowledge of the Code of Federal Regulations, International Council for Harmonisation (ICH) guidelines, and Good Clinical Practice (GCP) guidelines and their application to clinical research to support staff training.
- Independently manage assigned studies from initiation through completion, typically spanning one to five years.
- Collaborate with external organizations, sponsors, CROs, physicians, internal staff, and C5 caregivers.
- Perform 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
- Three years of clinical research experience or three years clinical experience
- Demonstrated team, leadership, organizational and problem-solving abilities
- Excellent interpersonal, organizational and project management skills
Preferred qualifications for the ideal future caregiver include:
- Bachelor's degree
- The following certifications are preferred: Certified Clinical Research Professional (CCRP) from the Society of Clinical Research Associates; or Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), or Certified Principal Investigator from the Association of Clinical Research Professionals
- LPN/RN License
- Cardiac experience
- Research experience
- Clinical Background (Nursing or Cardiac)
- Experience coordinating or managing clinical research studies
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 drug free environment. All offers of employment are followed by testing for controlled substances.
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.
If applying for a Florida position, please see the following website for more information on the background screening requirements required by the Agency of Health Care Administration: https://info.flclearinghouse.com/
Please review the Equal Employment Opportunity poster.
Cleveland Clinic is pleased to be an equal employment opportunity employer.
