Clinical Research Nurse

Essential Job Duties: In collaboration with other members of the clinical research site team, works to ensure

the execution of assigned studies. Responsibilities may include but are not limited to:

• Under the direction of the Site Manager/Director and the Principal/Sub Investigators, conducts the

following according to study protocol, company processes & procedures, and in compliance with FDA,

GCP, ICH regulations and guidelines:

o Screening of patients for study enrollment;

o Patient consents;

o Patient follow-up visits;

o Documenting in source clinic charts;

o Entering data in EDC and answers queries;

o Obtaining vital signs and ECGs;

o May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge

operation, storing and shipping of lab specimens, accountability of specimens and notification

of courier for specimen pick-up;

o Performing procedures commensurate with licensure including vitals, ECGs/EKGs,

venipunctures, injections, infusions, mixing drug and/or dispense investigational product; etc.

o Requesting and tracking medical record requests;

o Updating and maintaining logs, chart filings;

o Maintaining & ordering study specific supplies;

o Scheduling subjects for study visits and conducts appointment reminders;

o Building/updating source as needed;

o Conducting monitoring visits and resolves issues as needed in a timely manner;

o Ensuring study related reports and patient results are reviewed by investigator in a timely

manner;

o Filing SAE/Deviation reports to Sponsor and IRB as needed;

o Documenting and reporting adverse events;

o Reporting non-compliance to appropriate staff in timely manner;

o Maintaining positive and effective communication with clients and team members;

o Always practicing ALCOAC principles with all documentation;

• Be thoroughly familiar with the protocol, case report form, informed consent, source documentation,

patient diary (when applicable), and study medication(s) for the assigned research study;

• Complete all needed activities for study start-up, including completing required training, uploading /

printing certificates to file in ISF, etc.;

• Prepare and attend site initiation visits (SIV’s) and Investigator Meetings (IMs), as needed;

• May set up, train and maintain all technology needed for studies.

• May assist with study recruitment, patient enrollment, and tracking as needed;

• Maintaining confidentiality of patients, customers and company information, and;

• Performing all other duties as requested or assigned.