Department

Study Management (CRC)

Purpose

The purpose of the Study Coordinator is to facilitate the study from start to finish. The Study Coordinator ensures the success of the study is achieved by working one on one with the study subject and the Principal Investigator throughout the duration of the study. The Study Coordinator will possess a high level of knowledge of study specific protocols and be the main contact for all study related questions and concerns.

Job Responsibilities

The Study Coordinator position reports to the Site Director and is responsible for the coordination and administration of clinical studies under the direction of the Site Director, Quality Assurance Manager, and the Medical Director/Principal Investigator. The Study Coordinator role and responsibilities include but are not limited to the ability to do:

• Review and understand study protocols as assigned
• Complete required training and adhere to safety and privacy regulations (HIPAA, IATA, FDA guidelines, ICH Good Clinical Practice, etc.)
• Prepare study-related source documentation according to protocol and system guidelines and work with Lead Study Coordinator and QA department collaboratively to make appropriate changes
• Communicate with and assist the Laboratory Technician regarding initial set of lab and ongoing maintenance
• Order, track, maintain, and organize Investigation Product, lab kits, supplies and devices necessary for study completion
• Prepare for study visits in a timely manner prior to subject enrollment, including preparation of subject binder and all requirements for visit
• Review eligibility of potential study subjects through methods such as careful review of the protocol (inclusion/exclusion criteria), subject interviews, request and review of medical records, and discussion with Principal Investigator
• Schedule study subjects for appointments and procedures as required by study protocols
• Obtain Informed Consent from study subjects prior to any study procedures and document appropriately
• Send out notification of study participation to primary care providers, if agreed to by subjects
• Educate study subjects on study procedures such as diary completion, electronic devices and expected outcomes in a profession and accountable manner following protocol requirements
• Process and ship lab samples if Lab Technician is unavailable
• Complete electronic data capture (EDC) and address all queries in a timely manner
• Maintain required records of study activity including subject binders and regulatory binders, and assist with end of study archiving documents
• Laboratory processing as needed
• Responsible for assuring training and documentation is completed for protocol amendments, ICFs, updated guidelines, etc.
• Communicate with Research staff on an ongoing basis regarding study updates, amendments/ changes
• Communicate with Investigators on an ongoing basis regarding study progress, laboratory notifications, safety issues and other important information
• Maintain contact with sponsors/CROs and respond in a timely manner as well as schedule/ coordinate site visits
• Prepare and review subject charts for completeness and accuracy prior to site monitoring visits
• Professional communication and collaborative work ethic with CRAs at Site visits.
• Record adverse events and serious adverse events in a timely manner and discuss with Principal Investigator and Site Director regarding the reporting of events to oversight agencies
• Track screening and enrollment status of study subjects and update study trackers routinely, including routing sheets for subject payments and invoices
• Perform specific protocol procedures as delegated, such as interviewing study subjects, taking vital signs, and performing electrocardiograms, etc.
• Prepare for or participate in quality assurance audits conducted by sponsors, federal agencies or specially designated review groups

Other duties as assigned

Additional Dialysis Study Responsibilities

• Initiate DaVita staff training, including the Facility Administrator (FA) and dialysis nurses, and maintain documentation of training (protocol, ICF, lab collection, and IP administration)
• Request treatment detailed report and patient summary report for study subjects in a timely manner, and as needed
• Transport lab kits and IP to and from dialysis centers per sponsor guidelines and site SOP
• Communicate effectively with DaVita FA, dialysis nurses, and other staff

Qualifications

• 3 to 5 years of experience in clinical research setting or related work environment is required
• Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA)
• Solid understanding of statutes and guidelines relevant to regulatory affairs in clinical research
• Familiarity with or ability to learn clinical trial management system software
• CRA certification required or obtained within 6 months of employment
• CCRC certification preferred or obtained within 6 months of employment

Education

• Bachelor’s degree in a health-related field (e.g., Nursing, Public Health, Biology, Psychology or related discipline) required.
• Relevant experience will be considered in lieu of a degree.

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the responsibilities of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform required job responsibilities.

• Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel.
• Ability to lift and/or move up to 25 pounds.
• Must have a driver’s license and personal vehicle (dialysis studies only)

Benefits:

• Competitive Salary
• 401(k)
• Employee assistance program
• Health insurance
• Paid time off
• Tuition reimbursement

Johnson County Clinical Trials and its subsidiary, Clinical Research Consultants, are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.