Clinical Research Coordinator

Clinical Research Coordinator

www.gihealthcare.com

Responsible in the site management of Clinical Research studies in all facets of GI Clinical Research studies. Performing tasks required to coordinate and complete a study according to the protocol.

Key Responsibilities:

• Adheres to Research SOP’s, Good Clinical Practices, Study Protocol and other training.
• Creates and updates source documents, progress notes and other study documents.
• Accurately collects study data via source documents/progress notes as required by the protocol
• Prompt entry of visit data in the Electronic Data Capture (EDC) and/or Case Report Forms (CRF) as required by the study sponsor
• Assists in patient screening to identify potential subjects according to the inclusion/exclusion criteria of the study.
• Obtaining proper informed consent for each study patient prior to any study-related procedures being performed, answering study related questions, and providing patient with a copy of signed consent form.
• Dispenses any study related medications (when applicable)
• Responsible for accurately filing documents in the Subject binders or source documents and the Regulatory binder
• Maintain patient confidentiality of all charts, supplies, and study information
• Performs technical requirements of the study protocol, i.e. lab work, shipping, pregnancy tests, ECG, vital signs, or any other procedure specified by protocol
• Reviews the subject binders/source documents prior to monitor visits, participates in monitor visits and answers queries during the visit
• Maintains study logs according to study protocol (e.g. Subject logs, travel logs, data logs, electronic data entry)
• Ensures that the investigational drug or device is received, stored, distributed, and documented according to study protocol (when applicable)
• Ensures proper handling and/or shipment of any pathology or lab specimen(s) obtained for study purposes (when applicable)
• Immediately reports serious adverse events and/or protocol deviations to PI, CRC and sponsor in a timely manner
• Completes all required documentation of study visits and follow up visits or phone calls in a timely and accurate manner
• Schedules subject research visits and appointments and maintains the study calendar
• Maintains temperature and humidity logs for study equipment and report variances to PI and/or CRC
• Assists with study closure and return of excess materials to the sponsor according to sponsor guidelines, and storage of study documents for required time period
• Attends scheduled conference calls with study sponsors
• Maintains communication with the monitor from the sponsoring company through telephone contact, written communication, and on-site visits.
• Addresses all queries or data clarifications in a timely manner.

Qualifications for Clinical Research Coordinator

• Graduate of an accredited RN program with current State of Tennessee licensure
• Must have proficient computer skills with systems such as Microsoft Office, Excel and a willingness to learn other applications
• Effective oral and written communication skills for interaction with patients, CRC, study monitors, and PI
• Full-time position with flexibility on start and stop times according to patient schedule
• This position may involve travel to other office locations on an as-needed basis
• Study may require that you attend or observe study related procedures
• The duties, responsibilities and activities may change without notice to comply with study requirements