Clinical Research Project Manager - Pediatrics

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. Job Details Applicants must reside near Cleveland, OH Join Cleveland Clinic Children's where research and surgery are advanced, technology is leading-edge, patient care is world-class, and caregivers are family. Cleveland Clinic Children's team of more than 300 caregivers are dedicated to the medical, surgical, and rehabilitative care of infants, children and adolescents. Here, you will work alongside passionate and dedicated caregivers, receive endless support and appreciation, and make meaningful differences in the lives of others every day. As a Clinical Research Project Manager, you will handle various research-related projects within the Pediatrics department. In this role, you will focus on performing the essential behind-the-scenes work required to support innovative treatments. You will contribute clinical insight to the design and conduct of these trials and oversee administrative functions for single and multi-institutional research trials. You will also manage the daily operations of Phase I–IV clinical studies and facilitate key communications to support academic trial coordination. This is a hybrid position after the new hire period (3-6 months). A caregiver in this position works 8:00am to 5:00pm. Some flexibility with start and end times will be needed.

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
Background/ability or working with clinical studies and clinical research team members at all levels
Complete training in Human Subjects Research (HSR) as required by the Responsible Conduct of Research guidelines adopted by the Cleveland Clinic within 90 days of hire

Nice To Haves

Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) Certification
Supervisory experience

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.
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.
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.
Improve quality and make recommendations to discontinue site if necessary.
May assist with the development, implementation and evaluation of research subject recruitment strategies, including marketing strategies, to maximize enrollment and retention.