Job Description

Job Description

Job Description

Job Description: Clinical Research Coordinator

An opportunity to contribute to groundbreaking research, support the development of new treatments, and improve the lives of patients. Responsible in the site management of GI clinical research studies. Performing tasks required to coordinate and complete a study according to the protocol. Previous Clinical Research experience is not required, but preferred. On the job training will be provided.

Key Responsibilities:

· Adheres to Research SOPs (Standard Operating Procedures) and study protocol while maintaining current training in Good Clinical Practice (GCP), IATA training, and study-specific training.

· Maintains patient confidentiality of all charts, supplies, and study information.

· Ensures the rights, safety, and welfare of all subjects at all times.

· Assists with patient recruitment by screening potential subjects in the Electronic Medical Record (EMR)

according to the Inclusion/Exclusion Criteria.

· Prepares source documents, kits, and other study materials for study visits.

· Obtains proper informed consent for each study patient prior to any study-related procedures being performed, answers study-related questions, and provides patient with a copy of signed consent form including emergency contact information.

· Creates and updates source documents, progress notes, and other study documents.

· Accurately collectsstudy data via source documents, progress notes, and EMR records as required by the protocol.

· Completes all required documentation of study visits, follow up visits, and/or phone calls in a timely and accurate manner.

· Dispenses any study-related medications (when applicable).

· Performs study subject activities as required by protocol (e.g. vital signs, ECG, pregnancy tests, lab work, etc.).

· Prompt entry of visit data in the Electronic Data Capture (EDC) and/or Case Report Forms (CRF) as required by the study sponsor.

· Responsible for accurately scanning, faxing, and/or filing Regulatory and source documents.

· Reviews the subject binders/source documents prior to monitor visits, participates in monitor visits, and answers queries during the visit.

· Assists with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol.

· Maintains study logs including, but not limited to subject enrollment, travel, temperature, subject stipend, shipping, and biological sample logs.

· Maintains temperature and humidity logs for study equipment and report variances to Pl and/or study sponsor.

· Ensures that the labcollection kits, investigational drug, or device is received, stored, distributed, and documented according to study protocol.

· Ensures proper handling, processing, and shipment of pathology or lab specimen obtained for study purposes.

· Promptly reports all adverse eventsand/or protocol deviations to the Pl, Sponsor, and IRB as assigned.

· Schedules subject research visits/appointments andmaintains the study calendar.

· Assists with study closure, 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 including remote monitoring, Site Initiation Visits, etc.

· 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.

· Prepares for FDA or Sponsor audit by ensuring all documentation and Case Report Forms are available and complete.

Job Requirements:

• Graduate of an accredited LPN program with current State of Tennessee licensure.

• Excellent organizational, analytical, and problem solving skills.

• Strong attention to detail.

• Effective oral and written communication skills.

• Good computer skills and basic math skills.

• Work in a collaborative, effective manner with clinical research staff.

• Ability to coordinate activities with other research team members.

• May involve limited local travel to other sites on an as needed basis.

• Study may require that you attend or observe study-related procedures.

• The duties, responsibilities, and activities may change to comply with study requirements.

Physical Requirements:

• Ability to stand and walk throughout the day.

• Prolonged periods of sitting and performing administrative duties including the use of computers.

• Ability to bend, twist, stoop, and reach.

• Able to lift and carry supplies and equipment as needed (up to 15 pounds).

Job Tags

Similar Jobs