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.

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.
• Offset:  Associate’s degree and five years of experience.
• Offset:  Master’s degree and two years of experience.

Preferred Qualifications

• Monitoring experience with CRO/ARO or Cardiovascular/Thoracic clinical research coordinator experience

​

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.

Keywords: Clinical Research Lead, Human Subject Research, Cardiovascular Thoracic, Heart Vascular