Clinical Research Project Manager

ccf; Town of Weston (WI); Presencial; USD 90 000 - 120 000; Tempo integral

Resumo da oferta

Cleveland Clinic Health System in Weston seeks a Clinical Research Project Manager to oversee administrative functions for multi-institutional trials. You will coordinate daily trial activities, manage communications among sponsors, sites, and IRBs, and provide clinical perspective on study design and conduct.

The role requires a Bachelor’s degree in a health care discipline or related field, experience in clinical research, and familiarity with FDA regulations and GCPs.

Qualificações

• Bachelor's degree or higher in a healthcare, science, or related field is required.
• SOCRA or ACRP certification desirable.
• Experience with FDA regulations, GCPs and internal SOPs.

Responsabilidades

• Oversees administrative functions of single/multi-institution trials.
• Coordinates daily organization and operational activities for trials (Phase I-IV).
• Facilitates trial communications and provides clinical perspective on design and conduct.
• Manages a trials team and coordinates budgets, contracts, and regulatory docs.
• Maintains relationships with sponsor, IRBs, FDA, and sites.
• Coordinates development and approval of protocols andCRFs.

Conhecimentos

Clinical research

Project management

Communication skills

Regulatory knowledge

Cross-functional coordination

Formação académica

Bachelor's degree in nursing, general science, a health care discipline, or computer science with programming emphasis

Associate's degree substitute for work experience

Master’s degree substitute for work experience

HS Diploma/GED substitute for work experience

Descrição da oferta de emprego

At Cleveland Clinic Health System, we believe in a better future for healthcare. And each of us is responsible for honoring our commitment to excellence, pushing the boundaries and transforming the patient experience, every day.

We all have the power to help, heal and change lives — beginning with our own. That’s the power of the Cleveland Clinic Health System team, and The Power of Every One.

Job Title

Clinical Research Project Manager

Location

Weston

Facility

Krupa Center Weston

Department

Research-Weston Hospital

Job Code

001551

Shift

Days

Schedule

8:30am-5:30am

Job Summary

Oversees the administrative functions of single and/or multi-institutional research trials. Coordinates/Manages daily organization and operational issues/activities related to Phase I-IV clinical research trials. Facilitates key trial communications for academic coordination, provides clinical perspective to the design and conduct of clinical trials.

Job Details

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 yearsof relevantexperiencecan substitute for work experience.
• Master’s 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: https://info.flclearinghouse.com/

Please review the Equal Employment Opportunity poster.

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