Clinical Research Project Manager

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:

• Bachelors degree in nursing general science a health care discipline or computer science with programming emphasis required.
• Associates degree and five yearsof relevantexperiencecan substitute for work experience.
• Masters degree and two yearsof relevantexperience can substitute for work experience.
• HS Diploma/GED and seven yearsof relevant 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.

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.

The policy of Cleveland Clinic Health System and its system hospitals (Cleveland Clinic Health System) is to provide equal opportunity to all of our caregivers and applicants for employment in our drug free environment. All offers of employment are followed by testing for controlled substances.

Cleveland Clinic Health System administers an influenza prevention program. You will be required to comply with this program which will include obtaining an influenza vaccination on an annual basis or obtaining an approved exemption.

Decisions concerning employment transfers and promotions are made upon the basis of the best qualified candidate without regard to color race religion national origin age sex sexual orientation marital status ancestry status as a disabled or Vietnam era veteran or any other characteristic protected by law. Information provided on this application may be shared with any Cleveland Clinic Health System facility.

If applying for a Florida position please see the following website for more information on the background screening requirements required by the Agency of Health Care Administration: review the Equal Employment Opportunity poster.

Cleveland Clinic is pleased to be an equal employment opportunity employer.