- Works in collaboration with the Principal Investigator (PI).
- Assists Regulatory Specialist in maintaining regulatory documents.
- Conducts protocol and feasibility evaluation.
- Assesses patient population, recruitment and enrollment strategies.
- Recruits and manages trial subjects to include screening patients for protocol eligibility, covering informed consent, screening and inclusion/exclusion of the subjects adhering to safety and compliance issues.
- Performs and/or coordinates tissue processing and subject's participation in clinical diagnostic procedures.
- Assists with maintenance of research related inventories for approved studies.
- Assists in accurate and timely data collection, collection of source documents documentation, data entry, and reporting.
- Schedules, coordinates planning and participates in monitoring and auditing activities. Participates in required training and education programs.
- Assists PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to but not limited to, protocol requirements, schedule of subject visits, execution of research plan.
- Retains all study records in accordance with sponsor requirements. Maintains effective and timely communications with sponsor, research subjects and PI during the course of the study. Maintains documentation of training.
- Provides a safe environment for patients, families, and clinical staff at all time through compliance with all federal, state, and professional regulatory standards.
- Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Reports instances of noncompliance to appropriate institutional oversight body.
- Recognize potential obstacles and work to resolve them within set timelines.
- Close-out of the clinical trial, contributing to research article, audit preparation, trial closure, communication with authorities and other disciplines involved, assisting in the final study report, completing financial obligations and archives study materials.
- Statistical analysis of study data
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Clinical Research Coordinator - Urbana, United States - Carle Foundation Hospital
Description
efforts to identify genes associated with the connective tissue disorder
hypermobile EDS (hEDS). Under the direction of Dr Christina Laukaitis
(Principal Investigator), Carle is collaborating with Carle Illinois College of
Medicine/University of Illinois to gather and analyze data and biospecimens
collected from people with hEDS and other genetic connective tissue disorders.
The primary duties of the Clinical Research Coordinator (CRC) will be to
facilitate and coordinate the daily activities of the research program,
including scheduling and communicating with study participants, obtaining
informed consent, coordinating study procedures (including physical examination
and sample collection), drafting and maintaining regulatory documentation, and
coordinating efforts between multiple research teams. The CRC will work with
the PI to develop new protocols, design efficient clinical workflows, and
facilitate IRB submissions and reviews. The CRC will also enter study data into
and retrieve study data from research databases, including REDCap. There will
be ample opportunity for this position to work with other clinical departments
and research programs at Carle.
