Clinical Research Project Manager - Center for Value Based Care

Cleveland Clinic•Cleveland, OH

1d•Hybrid

About The Position

The Clinical Research Project Manager oversees research projects within the Center for Value Based Care, primarily supporting the administrative and operational work required to advance innovative treatments. The role collaborates with researchers and clinical caregivers, contributes clinical perspective, supports budgeting and contracting, monitors patient visits, and facilitates daily study operations. The position supports externally funded projects in PCI and contributes to Cleveland Clinic’s mission to create value in healthcare and enhance care delivery. Projects span multiple disciplines across the system. The role oversees administrative functions for single- and multi-institutional trials and coordinates Phase I–IV clinical research activities. It supports trial design and conduct, team coordination, communications, regulatory documentation, site selection and performance, and recruitment and retention strategies. The position is based at Cleveland Clinic Main Campus in Cleveland. It is fully on site during the new-hire period and transitions to a hybrid schedule after training, typically with two to three days in the office. Occasional travel to regional hospitals and Family Health Centers may be required.

Requirements

Bachelor’s degree in Nursing, Science, Healthcare, or Computer Science with an emphasis on programming, and three years of clinical research experience as a Study Coordinator, Project Manager, Contract Research Associate, or equivalent in a related field; OR a high school diploma/GED and seven years of experience; OR an associate’s degree and five years of experience; OR a master’s degree and two years of experience.
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 the Code of Federal Regulations, ICH and GCP guidelines, and their applications to clinical research trials.
Complete Human Subjects Research (HSR) training within 90 days of hire.

Nice To Haves

Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) certification.
Supervisory experience.
Familiarity and experience with healthcare operations.

Responsibilities

Oversee administrative functions of single- and/or multi-institutional research trials.
Coordinate and manage daily organization and operational activities related to Phase I–IV clinical research trials.
Facilitate key trial communications for academic coordination.
Provide clinical perspective to the design and conduct of clinical trials.
Manage and coordinate clinical trial teams, including external industry team members, statisticians, database programmers, and researchers responsible for data accumulation, input, and analysis.
Work with Finance and Legal Departments to facilitate clinical trial budgets, site budgets, and contract execution.
Maintain professional relationships with sponsors through frequent, open communication and associated documentation.
Coordinate development, preparation, review, and approval of research protocols, case report forms, and regulatory documents required by the IRB, sponsor, and FDA.
Collect and review regulatory documents from sites.
Communicate with institutional and central IRBs, the 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 communications with sites, including newsletters, study progress updates, telephone communication, and supportive reinforcement of sponsor communication.
Analyze site strengths and weaknesses in relation to the protocol and select qualified investigators and sites.
Assess investigator and site performance.
Lead quality-improvement initiatives and recommend discontinuing sites when necessary.
Assist with developing, implementing, and evaluating research subject recruitment strategies, including marketing strategies, to maximize enrollment and retention.
Complete Human Subjects Research (HSR) training within 90 days of hire.