Clinical Research Project Manager - Pediatric Hematology-Oncology

Cleveland Clinic•Cleveland, OH

3d•Onsite

About The Position

The Clinical Research Project Manager oversees administrative functions and daily operations for single- and multi-institutional Phase I–IV clinical research trials in Pediatric Hematology-Oncology. The role coordinates research teams and trial communications, supports protocol and regulatory document development, and provides clinical perspective on trial design and conduct. The position also works with Finance and Legal on budgets and contracts, maintains sponsor and site relationships, monitors site and investigator performance, and supports participant recruitment and retention. The caregiver works days, generally from 8:30 a.m. to 5:00 p.m., although start and end times may vary. Human Subjects Research training must be completed within 90 days of hire.

Requirements

One of the following education and experience combinations: Bachelor's degree in Nursing, Science, Healthcare, or Computer Science with an emphasis on programming, plus three years of clinical research experience as a Study Coordinator, Project Manager, Contract Research Associate, or equivalent in a related field; high school diploma/GED plus seven years of experience; associate degree plus five years of experience; or master's degree plus 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, Good Clinical Practices (GCPs), and internal standard operating procedures (SOPs).
Knowledge of the Code of Federal Regulations, ICH guidelines, and GCP guidelines and their applications to clinical research trials.
Background or ability to work with clinical studies and clinical research team members at all levels.
Successfully complete Human Subjects Research training within 90 days of hire.
Ability to perform the physical requirements of the role, including extensive standing and walking, full range of motion, manual and finger dexterity, and eye-hand coordination.
Normal or corrected hearing and vision to normal range.

Nice To Haves

SOCRA or ACRP certification.
Grant submission and post-award experience.

Responsibilities

Oversee administrative functions of single- and multi-institutional research trials.
Coordinate and manage daily organization and operational activities for Phase I–IV clinical research trials.
Facilitate key trial communications for academic coordination and provide clinical perspective on clinical trial design and conduct.
Manage and coordinate a clinical trials team responsible for data accumulation, input, and analysis, including external industry team members, statisticians, database programmers, and researchers.
Work with Finance and Legal to facilitate clinical trial budgets, site budgets, and contract execution.
Maintain professional relationships with sponsors through frequent communication and associated documentation.
Coordinate development, preparation, review, and approval of research protocols, case report forms, and regulatory documents required by the IRB, sponsors, 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 communications with sites, such as newsletters, study progress updates, telephone communications, and supportive reinforcement of sponsor communications.
Analyze site strengths and weaknesses in relation to protocols and the selection of qualified investigators and sites.
Assess investigator and site performance.
Lead quality improvement initiatives and recommend discontinuing sites when necessary.
Assist in developing, implementing, and evaluating subject recruitment strategies, including marketing strategies, to maximize enrollment and retention.
Complete Human Subjects Research training as required by Cleveland Clinic's Responsible Conduct of Research guidelines.
Perform other duties as assigned.