Clinical Research Coordinator I: Digestive Disorders

Hoag • Newport Beach, CA

1d

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

• High School Diploma with sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
• Excellent verbal and written communications and presentation skills
• Excellent organizational skills
• Excellent interpersonal skills to work effectively in a diverse team.
• Attention to details.
• Proficiency with Microsoft Word, PowerPoint, and Windows.
• Excellent analytical and problem-solving skills.
• Ability to work effectively in a fast-paced, team-based environment
• Project management and coordination skills
• Ability to prioritize tasks and meet multiple deadlines on concurrent projects.
• Ability to establish cooperative working relationships with patients, co-workers, & physicians.

Nice To Haves

• Medical terminology required.
• Working knowledge of FDA, NIH and OHRP regulatory requirements and ICH GCP guidelines.
• Understanding of clinical trial methodologies and experience filing Institutional Review Board documents.
• Ability to abstract data from medical records and transfer it to data collection forms or directly into databases.
• International Air Transport Association (IATA) Certification
• Current ACRP or SoCRA Certification.

Responsibilities

• Responsible for all aspects of clinical research activities
• 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.
• 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.
• 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).
• 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.
• Must be knowledgeable of Good Clinical Practices, protection of human subjects in research practices, and FDA regulatory guidelines regarding clinical research.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED