Clinical Research Project Manager - Pediatric Hematology-Oncology

Cleveland Clinic•Cleveland, OH

4d•Onsite

About The Position

Cleveland Clinic Research is seeking a passionate Clinical Research Project Manager to join their team. This role plays a crucial part in managing clinical research that drives innovation and improves patient outcomes. The position is specifically within Pediatric Hematology and Oncology, supporting research and clinical trials for young cancer patients. The role involves interacting with various research teams and contributing to the advancement of medicine. The work schedule is typically 8:30 am to 5:00 pm, with potential variations in start and end times.

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
Within 90 days of hire, must successfully complete training in Human Subjects Research (HSR) as required by the Responsible Conduct of Research guidelines adopted by the Cleveland Clinic

Nice To Haves

Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) Certification
Grant submission and post-award 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.
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) as required by the Responsible Conduct of Research guidelines adopted by the Cleveland Clinic.
Perform other duties as assigned.