Academic Center Project Manager I

Cleveland Clinic

3d•Hybrid

About The Position

The Academic Center Project Manager I supports the management of single- and multi-institutional research trials, coordinating day-to-day operations for Phase I–IV clinical research studies. The role facilitates trial communications and academic collaboration, provides clinical perspective on trial design and conduct, and leads initiatives to ensure study quality and performance. It also supports Clinical Events Committee (CEC) activities by making independent, blinded determinations of clinical trial endpoints and events. The position does not involve direct patient care, but does include reviewing source documentation to determine whether clinical events occurred and coordinating adjudication with study partners, primarily for cardiovascular endpoints. The position is based at Cleveland Clinic Main Campus in Cleveland. The schedule is Monday through Friday, 8:00 a.m. to 4:30 p.m., and travel is required. After 90 days, the role offers a hybrid schedule of two days onsite and three days remote per week. Assigned studies are managed independently from initiation through completion and typically span one to five years.

Requirements

Associate's degree in general science or a related medical field, or a nursing degree/diploma.
Three years of clinical research experience or three years of clinical experience.
Demonstrated team, leadership, organizational, and problem-solving abilities.
Excellent interpersonal, organizational, and project management skills.

Nice To Haves

Bachelor's degree.
Certified Clinical Research Professional (CCRP) certification from the Society of Clinical Research Associates.
Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), or Certified Principal Investigator certification from the Association of Clinical Research Professionals.
LPN or RN license.
Cardiac experience.
Research experience.
Clinical background in nursing or cardiac care.
Experience coordinating or managing clinical research studies.

Responsibilities

Coordinate and contribute to protocol development and review, assessing clinical and regulatory considerations, current clinical practices, and experience with similar protocols.
Analyze site strengths and weaknesses to help select qualified investigators and study sites.
Conduct ongoing assessments of investigator and site performance.
Develop performance standards to support study integrity, quality of conduct, and overall 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), vendors, and the U.S. Food and Drug Administration (FDA).
Serve as the primary contact for academic leadership committees and coordinate committee activities, including charter development.
Coordinate site communications and training, including investigator meetings, newsletters, study updates, and telephone communications.
Develop educational initiatives, tools, and training materials for 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 apply them to clinical research and 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.