Clinical Research Project Manager

Position Overview

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. Cleveland Clinic is recognized as one of the top hospitals in the nation. At Cleveland Clinic, you will work alongside passionate and dedicated caregivers, 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 handle various research-related projects within your assigned department. In this role, your focus is mainly on performing the “behind-the-scenes” work necessary to provide innovative treatments. You will interact with fellow researchers and clinical caregivers throughout your day, providing perspective, working on budgets and contracts, monitoring patient visits and more. This position offers continued learning and growth, all while allowing you to not only make a difference in Cleveland but potentially the world.

Key Responsibilities

• Oversee the administrative functions of single and/or multi-institutional research trials.
• Coordinate and 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 of hire.

Required Qualifications

• 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.

Preferred Qualifications

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

Benefits & Perks

• Comprehensive health insurance
• 401k plan with matching
• Paid time off
• Tuition reimbursement
• Employee wellness programs