Research Coordinator III
- Employer
- Cleveland Clinic Foundation
- Location
- Cleveland, Ohio, United States
- Posted Date
- Jan 25, 2019
- Reference
- 50216
Job Details
Demonstrates exceptional coordination and compliance of the implementation and conduct of human subject research projects typically with a high workload and high complexity. Assists with research study design and protocol development as applicable.
Responsibilities:
- Independently directs large, complex, multi-center clinical research protocols/programs and coordinates the implementation and conduct of research projects ensuring adherence to research protocol requirements which may include: maintenance of regulatory documents and binders, data management, IRB submissions and communication of such to the research team, and the development of data capture and monitoring plans.
- May be responsible for reporting of Serious Adverse Events and/or safety log as defined per protocol as they occur and completion of Food and Drug Administration (FDA) and sponsor forms in accordance with GCP timelines.
- Communicates with sponsors, monitors, and research personnel to ensure all aspects of study compliance.
- Serves as a liaison between investigators, research personnel, outside study personnel and central research administration offices to assist in protocol interpretation, enrollment and safety questions.
- Collaborates with primary investigator, sponsor and research staff to plan, conduct and evaluate project protocols, including research subject recruitment.
- Monitors and reports project status.
- Completes regulatory documents, data capture and monitoring plans.
- Completes and may oversee protocol related activities.
- Oversees and monitors research data to maintain quality.
- Understands basic concepts of study design.
- Develops and maintains knowledge of research protocol to coordinate the comprehensive and compliant execution of assigned protocols.
- Assists with preparation for audits and response to audits.
- May develop or assist in the development and maintenance of research tools, such as spreadsheets, questionnaires and/or brochures.
- Maintains study personnel certification records (License, CV, CITI).
- Maintains professional relationships, including frequent and open effective communication with internal and external constituents.
- Assists with the development of training and educational material for assigned research protocols, and documents education as needed.
- Conducts and documents the informed consent process.
- Assists PI with research study design and development of research protocol.
- May submit the study to appropriate agencies in support of the research programs and assist with annual and other reporting requirements.
- Will contribute to or assist with research project budget development.
- Other duties as assigned.
Education:
- High School Diploma or GED. Associate's or Bachelor's degree in health care or science related field preferred.
- Bachelor's degree may offset two years of experience requirement.
- Demonstrated proficiency with a variety of computer-based skills, especially in the use of word processing, spreadsheets, database and presentation software, and the ability to undertake internet searches.
- Solid written and verbal communication skills.
- Must be self-directed with demonstrated ability to work in collaboration and cooperation with members of a multidisciplinary team.
- Within 90 days of hire, must successfully complete certification in Human Subjects Research as required by the Responsible Conduct of Research guidelines adopted by Cleveland Clinic.
- Continually demonstrates competency with defined requirements for the position as established by Cleveland Clinic.
Certifications:
- None required
Competencies (Complexity of Work):
- Is self-directed in planning, prioritizing and performing job requirements with minimal supervision.
- Exhibits the desire to expand job knowledge and skills through training and skill development.
- Must be able to work in a stressful environment and take appropriate action.
Work Experience:
- Minimum five years' experience as a Research Coordinator II or performing the role of a Research Coordinator II. Bachelor's degree in healthcare or science field may offset two years of clinical research experience requirement.
Physical Requirements:
- A high degree of dexterity to produce materials on a computer.
- Requires normal or corrected vision and hearing to normal range.
- Extensive sitting and frequent walking, occasional lifting or carrying up to 25 pounds.
- May have some exposure to communicable diseases or body fluids.
- May require working irregular hours.
Personal Protective Equipment:
- Follows standard precautions using personal protective equipment as required.
The policy of Cleveland Clinic and its system hospitals (Cleveland Clinic) is to provide equal opportunity to all of our employees and applicants for employment in our tobacco free and drug free environment. All offers of employment are followed by testing for controlled substance and nicotine. Job offers will be rescinded for candidates for employment who test positive for nicotine. Candidates for employment who are impacted by Cleveland Clinic's Smoking Policy will be permitted to reapply for open positions after 90 days. 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 facility.
Cleveland Clinic is pleased to be an equal employment employer: Women/Minorities/Veterans/Individuals with Disabilities
Company
Cleveland Clinic is one of the world's largest and busiest health centers. Patients come to Cleveland Clinic from all over the world. We offer advanced treatment for all illnesses and disorders of the body. We enjoy a strong reputation for outstanding quality care. U.S News & World Report has declared that we are the number two hospital in the country. In cardiology and cardiac surgery, we lead the nation.
Our Heart Center has been ranked number one in America for 21 years in row in U.S. News and World Report. Cleveland Clinic's Glickman Urological & Kidney Institute and Digestive Disease Institute are ranked very near the top, and our specialties of orthopaedics, otolaryngology, nephrology, neurology/neurological surgery, rheumatology, pulmonary, endocrinology, gynecology, ophthalmology and geriatrics are each among America's ten best in their fields.
Other specialties noted for national excellence include cancer and psychiatry. Cleveland Clinic Children's offers highly specialized pediatric care in a family-centered atmosphere. It has been ranked the best children's hospital in Ohio by Child magazine.
Cleveland Clinic was founded in 1921 as a not-for-profit group practice, integrating clinical and hospital care with research and physician education. In addition to our Cleveland location, we have Cleveland Clinic Florida, with a unified medical campus in Weston, Florida, offering the full spectrum of care.
Cleveland Clinic has more than 3,000 salaried physicians on staff, representing approximately 120 specialties and subspecialties. In 2015, they provided a total of 6.62 million visits. Patients came to us from across America and from more than 180 nations. We also lead an extensive system of community hospitals in Cleveland called the Cleveland Clinic Hospitals.
This system is made up of Cleveland Clinic and Fairview Hospital, Lutheran Hospital, Marymount Hospital, Euclid Hospital, Hillcrest Hospital, Medina Hospital, South Pointe Hospital, Akron General Hospital and the soon to open Avon Hospital. With 4,450 staffed beds, Cleveland Clinic Hospitals offers broad geographic coverage, a full continuum of care, improved quality and lower cost of care to Northeast Ohio residents.
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