Clinical Research Project Manager - Pediatrics jobs in United States
cer-icon
Apply on Employer Site
company-logo

Cleveland Clinic · 5 hours ago

Clinical Research Project Manager - Pediatrics

Cleveland Clinic is a leading healthcare provider dedicated to transforming the patient experience. The Clinical Research Project Manager will oversee various research-related projects within the Pediatrics department, managing clinical trials and facilitating communications to support academic trial coordination.

Health CareHospitalMedicalNon Profit
check
H1B Sponsor Likelynote

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
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
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
Improve quality and make recommendations to discontinue site if necessary
May assist with the development, implementation and evaluation of research subject recruitment strategies, including marketing strategies, to maximize enrollment and retention

Qualification

Clinical research experienceFDA regulations knowledgeGCP knowledgeHuman Subjects Research trainingSoftware technologies proficiencyScientificMedical knowledgeClinical studies backgroundSupervisory experience

Required

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
Complete training in Human Subjects Research (HSR) as required by the Responsible Conduct of Research guidelines adopted by the Cleveland Clinic within 90 days of hire

Preferred

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

Company

Cleveland Clinic

company-logo
Cleveland Clinic is a non-profit medical center that combines clinical and hospital care with research and education. It is a sub-organization of Ashtabula Regional Medical Center.

H1B Sponsorship

Cleveland Clinic has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (89)
2024 (78)
2023 (100)
2022 (60)
2021 (71)
2020 (46)

Funding

Current Stage
Late Stage
Total Funding
$362.54M
Key Investors
National Institutes of HealthNational Cancer InstituteAgency for Healthcare Research and Quality
2023-02-21Grant· $3.14M
2022-09-22Grant· $7.9M
2022-06-30Grant· $14.2M

Leadership Team

leader-logo
Delos Cosgrove
CEO & President
linkedin
leader-logo
Tomislav Mihaljevic
President & Chief Executive Officer, Cleveland Clinic
linkedin
Company data provided by crunchbase