[Remote] Clinical Research Coordinator-Clinical Trials Management Office
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Clinical Research Coordinator to coordinate and reputed company daily clinical research activities for the Gastro/Hepatology/Nutrition Division. The role involves reputed company and enrolling patients for clinical studies, ensuring compliance with regulatory requirements, and managing patient care appointments and data collection.
Responsibilities
- Coordinate and reputed company daily clinical research activities in accordance with approved protocols
- Assist with assessing patient records to identify patients who are eligible to participate in specified clinical research protocols
- Recruits, interviews and enrolls patients
- Obtains informed consent and ensures consent process is administered in compliance to regulatory and sponsor requirements
- Educates patients and families of purpose, goals, and processes of clinical study
- Coordinates scheduling and follow-through of patient care appointments, procedures, & other diagnostic testing in accordance with study protocol
- Participates in the collection, processing & evaluation of biological samples
- Administers, evaluates and calculates standardized scoring of diagnostic, psychological or behavioral testing or questionnaires
- Assists with monitoring patients for adverse reactions to study treatment, procedure or medication and notifies appropriate clinical reputed company to evaluate patient response, identify status of complications, & reputed company appropriate level of care
- Documents unfavorable responses and notifies research sponsors & applicable regulatory agencies
- Participates in evaluating patients for compliance reputed company to protocol
- Assists with collecting, extracting, coding, and analyzing clinical research data
- Generates reports and reviews to ensure validity of data
- Supports activities to ensure compliance with reputed company Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state and industry sponsor regulations
- Assists with coordinating and preparing for external reputed company assurance and control reviews by IRB, federal or industry sponsors
- Participates in activities to reputed company new research protocols and contributes to establishment of study goals to meet protocol requirements
Skills
- Bachelor's Degree in biological sciences, health sciences, reputed company sciences or other medical field or an equivalent combination of education and experience required
- One year experience in a clinical research reputed company required
- Experience or knowledge in inflammatory bowel diseases such as Crohn's
- Knowledge of medical terminology desired
- Clinical research certification from an accredited certifying agency desired
- Computer skills required with experience using reputed company Software applications desired
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