Clinical Research Project Manager - Pediatrics

Cleveland Clinic • Cleveland, OH

4d • Hybrid

About The Position

Cleveland Clinic’s Main Campus is hiring a Clinical Research Project Manager to oversee the administrative functions and daily operations of single- and multi-institutional Phase I–IV clinical research trials. The role facilitates academic collaboration and provides clinical perspective to the design and conduct of clinical trials. The position is based at Main Campus in Cleveland and is fully onsite during the first 3–6 months. After that period, there is an opportunity to move to a hybrid schedule with 2–3 remote days per week. The schedule is days, 8:30 a.m.–5:00 p.m.; relocation assistance is not available.

The project manager coordinates clinical trial teams and communications, supports trial budgets and contracts, oversees protocol and regulatory-document preparation and review, and communicates with sites, sponsors, institutional and central IRBs, the FDA, and other parties. The role also assesses site and investigator performance, supports subject recruitment and retention, and leads quality-improvement initiatives. Human Subjects Research (HSR) training must be completed within 90 days of hire.

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; alternatively, a high school diploma/GED and seven years of experience, an associate’s degree and five years of experience, or a 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 application to clinical research trials.
• Complete Human Subjects Research (HSR) training within 90 days of hire.

Nice To Haves

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

Responsibilities

• Oversee administrative functions of single- and/or multi-institutional research trials.
• Coordinate and manage daily organization, operational issues, and 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—including external industry team members, statisticians, database programmers, and researchers—responsible for data accumulation, input, and analysis.
• Work with Finance and Legal Departments to facilitate clinical-trial and site budgets and contract execution.
• Maintain professional relationships with sponsors through frequent, open communication and associated documentation.
• Coordinate development, preparation, review, and approval of research protocols, case report forms, and regulatory documents required by the IRB, sponsor, and FDA.
• Collect and review regulatory documents from sites.
• Communicate with institutional and central IRBs, the 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 reinforcement of sponsor communications.
• Analyze site strengths and weaknesses in relation to the protocol and selection of qualified investigators and sites.
• Assess investigator and site performance.
• Lead quality-improvement initiatives and recommend discontinuing sites when necessary.
• Assist with the development, implementation, and evaluation of research subject recruitment strategies, including marketing strategies, to maximize enrollment and retention.
• Complete Human Subjects Research (HSR) training within 90 days of hire.

Benefits

• Opportunity to work with a passionate and dedicated team and receive support and appreciation.
• Potential to transition to a hybrid schedule after the initial 3–6-month onsite period.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level