Clinical Research Project Manager - Center for Value Based Care

Cleveland Clinic

1d•Hybrid

About The Position

At Cleveland Clinic Health System, we believe in a better future for healthcare. And each of us is responsible for honoring our commitment to excellence, pushing the boundaries and transforming the patient experience, every day. We all have the power to help, heal and change lives — beginning with our own. That’s the power of the Cleveland Clinic Health System team, and The Power of Every One. 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 a Clinical Research Project Manager, you will oversee a variety of research projects within the Center for Value Based Care, focusing primarily on the behind-the-scenes work essential to advancing innovative treatments. In this role, you will collaborate with researchers and clinical caregivers, contribute perspective, support budgeting and contracting processes, monitor patient visits, and facilitate day-to-day study operations. This position allows you to support externally funded projects in PCI and contribute to the mission of Cleveland Clinic to create value in healthcare and enhance care delivery, with diverse projects that provide exposure to multiple disciplines across the system. Read more about the Center for Value Based Care: https://my.clevelandclinic.org/departments/community-care/research-innovations/care-research A caregiver in this role works days from 8:00 a.m. – 5:00 p.m. This role 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 depending on project needs.

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 High School Diploma/GED and seven years of experience OR Associate’s degree and five years of experience OR 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 training in Human Subjects Research (HSR) within 90 days or 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 the administrative functions of single and/or multi-institutional research trials.
Coordinate/manage daily organization and operational issues/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 a clinical trials team (external industry team members, statisticians, database programmers and researchers) responsible for data accumulation, input and analysis.
Interact with the Finance and Legal Departments to facilitate clinical trial budget, site budget and contract execution.
Maintain professional relationships with sponsors, including frequent, open communication and associated documentation.
Coordinate development, preparation, review and approval of research protocols, case report forms and regulatory documents for the conduct of research required by Institutional Review Board (IRB), Sponsor and FDA.
Collect and review regulatory documents from sites.
Communicate with institutional and central IRBs, 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 communication with sites (i.e., newsletters, study progress updates, telephone communication, supportive reinforcement of Sponsor communication, etc.).
Analyze site strengths and weaknesses related to intended protocol and selection of qualified investigators and sites.
Assess investigator and site performance.
Lead initiatives to improve quality and make recommendations to discontinue sites if necessary.
Assist with the development, implementation and evaluation of research subject recruitment strategies, including marketing strategies, to maximize enrollment and retention.
Complete training in Human Subjects Research (HSR) within 90 days or hire.