Clinical Research Coordinator I: Digestive Disorders
About The Position
Reporting to the Clinical Research Supervisor, Clinical Research Manager, or Director of Clinical Research Operations, the Clinical Research Coordinator I (CRC-I) is responsible for all aspects of clinical research activities and works in close cooperation with study physicians, inter- and intradepartmental stakeholders, and sponsors. The CRC-I provides support, coordination for FDA regulated research including data, blood and tissue collection studies that may involve industry-sponsored, government funded and/or investigator initiated clinical research trials. The CRC-I is involved in all aspects of research clinical process including, but not limited to protocol review, preparation and administration of the informed consent, completion of study related visit forms, ensuring protocol required assessments are completed per study guidelines, processing of lab samples per IATA standards, regular communication with study sponsors and their collaborators, and data entry into study systems within study required timeframes. The CRC I will ensure accurate completion of case report forms (CRFs), adverse event/serious adverse event (SAE) reporting, scheduled subject follow-up, and maintenance of regulatory binders. Discusses research study with potential study subjects and answers any questions (may refer questions to Principal Investigator or Sub-Investigator when appropriate) while obtaining informed consent as well as assisting in scheduling follow-up visits for enrolled subjects. Responsible for development of study flow sheets, prepare study source documentation, gather study data, and assess subject for study eligibility (inclusion/exclusion). In addition, the CRC-I will record protocol specific assessments and ensure collection and shipment of samples, complete study forms to submit to sponsors and/or appropriate agencies, collect, enters and clean data into study database while maintaining data quality. He/she will host study team meetings, attend site initiation visits (SIVs) and perform other duties as assigned. Performs other duties as assigned. Must be knowledgeable of Good Clinical Practices, protection of human subjects in research practices, and FDA regulatory guidelines regarding clinical research.
Requirements
- Must be knowledgeable of Good Clinical Practices
- Must be knowledgeable of protection of human subjects in research practices
- Must be knowledgeable of FDA regulatory guidelines regarding clinical research
Responsibilities
- Responsible for all aspects of clinical research activities
- Provide support, coordination for FDA regulated research including data, blood and tissue collection studies
- Involved in all aspects of research clinical process including, but not limited to protocol review, preparation and administration of the informed consent, completion of study related visit forms, ensuring protocol required assessments are completed per study guidelines, processing of lab samples per IATA standards, regular communication with study sponsors and their collaborators, and data entry into study systems within study required timeframes.
- Ensure accurate completion of case report forms (CRFs), adverse event/serious adverse event (SAE) reporting, scheduled subject follow-up, and maintenance of regulatory binders.
- Discuss research study with potential study subjects and answers any questions (may refer questions to Principal Investigator or Sub-Investigator when appropriate) while obtaining informed consent as well as assisting in scheduling follow-up visits for enrolled subjects.
- Responsible for development of study flow sheets, prepare study source documentation, gather study data, and assess subject for study eligibility (inclusion/exclusion).
- Record protocol specific assessments and ensure collection and shipment of samples, complete study forms to submit to sponsors and/or appropriate agencies, collect, enters and clean data into study database while maintaining data quality.
- Host study team meetings, attend site initiation visits (SIVs) and perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
