Clinical Research Coordinator I - Inflammatory Bowel Disease
About The Position
The Inflammatory Bowel Disease Center is seeking a full-time clinical research coordinator who will join a highly productive team focused on conducting a variety of research projects to understand inflammatory bowel disease (IBD), advance current treatments, improve quality of life, develop new therapies and find a cure for IBD. Under the supervision of the clinical research administrative director and/or Principal Investigator, the coordinator responsibilities include, but are not limited to, recruitment of research participants, including informed consent, interfacing with clinical care and lab staff to schedule research visits, ensuring adherence to study protocols, collecting, and entering data into the clinical study databases. Excellent communication, organizational, and time-management skills are important.
Requirements
- High School Diploma / GED - Required
- At least two (2) years of clinical or research related experience - Required
- Basic knowledge of IRB and human subject protection
- Strong verbal and written communications skills
- Strong time management skills
- Ability to collaborate with stakeholders at all levels
Nice To Haves
- Bachelor's Degree - Preferred
- At least three (3) years of clinical or research related experience - Preferred
Responsibilities
- Adhere to an IRB approved protocol
- Participate in the informed consent process of study subjects
- Support the safety of clinical research patients/research participants
- Coordinate protocol related research procedures, study visits, and follow-up care
- Screen, recruit and enroll patients/research participants
- Maintain study source documents
- Under the supervision of PI Report adverse events
- Understand good clinical practice (GCP) and regulatory compliance
- Educate subjects and family on protocol, study intervention, etc.
- Comply with Institutional policies, standard operating procedures (SOPs) and guidelines, and with HIPAA and management of confidential materials
- Must comply with federal, state, and sponsor policies
- For multi-site studies or collaborations, support communication and meeting scheduling across teams
- Manage essential regulatory documents
- Register study on ClinicalTrials.gov as appropriate
- Complete case report forms (paper & electronic data capture) and address queries
- Submit documents to regulatory authorities (e.g. IRB, FDA, etc.) and/or review/monitoring boards (ie,DSMB, independent safety officer)
- Facilitate pre-study, site qualification, study initiation, and monitoring visit as appropriate
- Facilitate study close out activities as appropriate
- Coordinate research/project team meetings
- Collect, process and ship samples as applicable to the protocol
- Schedule subject visits and procedures
- Retain records/archive documents after study close out
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
