Clinical Research Project Manager - Pediatrics

ccf; Cleveland (OH); Hybrid; USD 85,000 - 110,000; Full time

Job summary

Cleveland Clinic Health System is seeking a Clinical Research Project Manager - Pediatrics to lead administrative operations for Phase I–IV pediatric trials at the Main Campus in Cleveland. You will coordinate daily trial activities, support academic collaboration, and contribute clinical insight to study design and execution.

The role involves transitioning from fully onsite to a hybrid model after 3–6 months, with 2–3 remote days per week.

Qualifications

• Bachelor's degree plus 3 years of clinical research experience or equivalent
• Experience with coordinating single and multi-institutional trials
• Knowledge of FDA regulations, GCPs and SOPs
• Experience developing budgets and managing trial finances
• Strong communication and cross-functional collaboration skills

Responsibilities

• Oversee administrative functions of single- and multi-institutional trials.
• Coordinate daily operations and activities of Phase I–IV clinical trials.
• Facilitate trial communications to support academic collaboration.
• Provide clinical perspective to trial design and conduct.
• Manage a clinical trials team including external partners and statisticians.
• Interface with Finance and Legal for budgets, site budgets and contracts.
• Maintain sponsor relationships with open documentation and updates.
• Prepare and review protocols, case report forms, and regulatory documents for IRB/FDA.
• Coordinate regulatory documents and site communications.
• Organize Investigator Meetings and sponsor communications.

Skills

Project management

Clinical research

FDA regulations

GCP knowledge

Communication skills

Education

Bachelor's degree in Nursing/Science/Healthcare or Computer Science

High School Diploma with seven years experience

Associate's degree with five years experience

Master's degree with two years experience

Job description

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 Title

Clinical Research Project Manager - Pediatrics

Location

Cleveland

Facility

Cleveland Clinic Main Campus

Department

RES Research Administration-Research Innov and Educ

Job Code

T26213

Shift

Days

Schedule

8:30am-5:00pm

Job Summary

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 the administrative functions of single- and multi-institutional research trials. In this role, you will coordinate and manage the daily operations and activities of Phase I-IV clinical research trials, facilitate key communications to support academic collaboration, and provide clinical perspective to the design and conduct of clinical trials.

A caregiver in this role works days from 8:30 a.m. - 5:00 p.m.

This position is fully onsite at Main Campus in Cleveland during the 3-6-month new-hire period.

After this period, there is an opportunity to transition to a hybrid schedule with 2-3 days per week remote. This position is not eligible for relocation assistance.

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 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.

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
• Complete training in Human Subjects Research (HSR) within 90 days or hire

Preferred qualifications for the ideal future caregiver include:

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

Physical Requirements:

Requires full range of motion, manual and finger dexterity and eye-hand coordination. Requires standing and walking for extensive periods of time. Requi