Vacancy caducado!
Job Summary:Coordinates the compliant implementation and conduct of human subject research projects typically with medium workload and medium complexity.Responsibilities:
Coordinates the implementation and conduct of research projects ensuring adherence to research protocol requirements including: timely completion and communication of regulatory documents, the development of data capture and monitoring plans, reporting of Serious Adverse Events as they occur and completion of Food and Drug Administration (FDA) and sponsor forms in accordance with GCP timelines.
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.
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.
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.
Provides and documents education as needed.
Conducts and documents the informed consent process.
Potentially assists with research project budget development.
Other duties as assigned.
Education:
Bachelor's degree in health care or science related field preferred.
Bachelor's degree in healthcare or science field may offset two years of clinical research experience requirement.
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.
Demonstrated basic computer proficiency.
Strong organizational, communication and interpersonal skills.
Must be self-directed with demonstrated ability to work independently yet establish cooperative relationships with colleagues.
Certifications:
None required.
Complexity of Work:
Requires critical thinking skills, decisive judgment and the ability to work with minimal supervision.
Must be able to work in a stressful environment and take appropriate action.
Work Experience:
Minimum three years clinical research experience required.
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
Vacancy caducado!