Clinical Research Project Manager - Pediatrics

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Position Overview

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 position is an excellent opportunity for individuals interested in advancing into a leadership role. It provides experience in team and workload management, training and coaching staff, research financial operations, and the regulatory requirements for conducting clinical research at Cleveland Clinic.

A caregiver in this role works: days from 8:00 a.m. – 5:00 p.m.

This is a hybrid role after training, with 2–3 days per week working remotely or on-site depending on patient needs.

Responsibilities

A caregiver who excels in this role will:

• 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 investigators 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.

Minimum Qualifications

Minimum qualifications for the ideal future caregiver include:

• 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

Preferred Qualifications

Preferred qualifications for the ideal future caregiver include:

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

Physical Requirements

Physical Requirements:

• Requires full range of motion, manual and finger dexterity and eye-hand coordination.
• Requires standing and walking for extensive periods of time.
• Requires normal or corrected hearing and vision to normal range.

Personal Protective Equipment

Personal Protective Equipment: Follows standard precautions using personal protective equipment as required.

Pay Range

Minimum Annual Salary: $63,250.00

Maximum Annual Salary: $96,467.50

The pay range displayed on this job posting reflects the anticipated range for new hires. A successful candidate’s actual compensation will be determined after taking factors into consideration such as the candidate’s work history, experience, skill set and education. The pay range displayed does not include any applicable pay practices (e.g., shift differentials, overtime, etc.). The pay range does not include the value of Cleveland Clinic’s benefits package (e.g., healthcare, dental and vision benefits, retirement savings account contributions, etc.).