Regional Clinical Research Project Manager

Join the Cleveland Clinic team, where you will work alongside passionate caregivers and provide patient-first healthcare. 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. 

The Clinical Research Project Manager oversees the administrative functions of single and/or multi-institutional research trials. You will coordinate/Manage daily organization and operational issues/activities related to Phase I-IV clinical research trials. In this role you will facilitate key trial communications for academic coordination, provides clinical perspective to the design and conduct of clinical trials.

The ideal caregiver is someone who:
• Has High-level management and leadership skills. 
• Has strong Clinical Research Experience.
• Has Regional experience is helpful
• Has teamwork and motivational skills. 
• Has organizational and multitasking skills. 

This is a rewarding opportunity that offers growth-oriented projects, mentorship, support, and resources. You will experience great exposure to both the institute and department leadership and have numerous opportunities for career growth in different administrative and project/program management.  

At Cleveland Clinic, we know what matters most. That's why we treat our caregivers as if they are our own family, and we are always creating ways to be there for you. Here, you'll find that we offer: resources to learn and grow, a fulfilling career for everyone, and comprehensive benefits that invest in your health, your physical and mental well-being and your future. When you join Cleveland Clinic, you'll be part of a supportive caregiver family that will be united in shared values and purpose to fulfill our promise of being the best place to receive care and the best place to work in healthcare. 

Responsibilities:

• Manages and coordinates a clinical trials team (external industry team members, statisticians, database programmers and researchers) responsible for data accumulation, input and analysis.
• Interacts with the Finance and Legal departments to facilitate clinical trial budget, site budget and contract execution.
• Maintains professional relationships with Sponsor including frequent, open communication and associated documentation.
• Coordinates 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.
• Communicates with institutional and central IRBs, FDA and other parties regarding protocol subject and safety issues.
• Organizes, coordinates, attends and participates in Investigator Meetings and training programs.
• Develops and maintains planned communication with sites (i.e., newsletters, study progress updates, telephone communication, supportive reinforcement of Sponsor communication, etc.).
• Analyzes site strengths and weaknesses related to intended protocol and selection of qualified investigators and sites.
• Assesses investigator and site performance.
• Lead initiative to improve quality and makes recommendation 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.
• Performs other duties as assigned.

Education:

• Bachelor's degree in nursing, general science, a health care discipline, or computer science with programming emphasis required. 
• Associate’s degree and five years of experience can substitute for work experience. 
• Master’s degree and two years of experience can substitute for work experience. 

Certifications:

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

Complexity of Work:

• Requires excellent interpersonal, organizational and project management skills. 
• 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 Code of Federal Regulations, ICH and GCP guidelines and their applications to clinical research trials.
• 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.
• Supervisor experience desirable.
• Demonstrated background/ability or working with clinical studies and clinical research team members at all levels.

Work Experience:

• •Minimum three years clinical research experience as a Study Coordinator, Project Manager, Contract Research Associate, or equivalent management experience in a related field required.
• Previous lab experience preferred.
• Phlebotomy experience highly preferred.

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:

• Follows standard precautions using personal protective equipment as required.