Clinical Research Coordinator II

Study Activities Coordinate and monitor specimen management processes to maintain chain-of-custody requirements, data accuracy, and research quality standards with laboratory personnel, investigators, and study sponsors. Perform study-related assessments, including ECGs, vitals, height and weight, dispensing of study medications and collecting adverse reactions and reports them to the investigator.

Introduce the study/recruit research participants into approved clinical trials. The primary clinical study for this position will be the biobanking of human tissues. This CRC will approach patients within our hospital system to consent them and then coordinate with the physicians and other staff (e.g., nurses, pathology) to obtain tissue within their pipeline.

Coordinate the patient care requirements of IRB approved clinical trials protocols. This includes consenting, screening, registering, re-consenting, scheduling appointments and procedures, creating documentation, and submitting data. Ensure proper data collection and submission of data into the appropriate data management systems including local clinical trials management system, the electronic medical record system and specific electronic data capture systems.

Sample collection and tissue processing. Sample collection will occur in coordination with surgeons and pathologists. Specimen preparation for shipment when necessary. Store samples per study specific protocol guidelines. Lab Management Under direction of the PI and Senior lab members, coordinate and carry out daily operations including Order/maintain laboratory supplies/equipment for the proposed studies.

Perform opening/closing procedures. Record daily freezer temperature Order dry ice, liquid nitrogen and other materials required for day to day activities Collect and log specimens into Open Specimen and REDCap databases. Receive, review requests from Open Specimen and retrieve and provide samples to study team. Work closely with team of other senior and junior CRCs to approach, consent, collect from, and process tissue samples from almost all patients at Banner.

Ability to work in a team with other team members who will also be consenting for both non-cancer and cancer samples. Assist with specimen management protocol development for specimen clinical trial. Participate in Site Evaluation Visits (SEV), Site Initiation Visits (SIV), monitoring visits and audits for Investigator Initiated trials (IITs), sponsored studies and cooperative group trials.

Under direction of the PI and Senior lab members, coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies. Analyze trends and data in recruitment and assure there is a limited number of competing trials. Make recommendations for a variety of options within a trial; track physician compliance.

Serve as a direct liaison between department of surgery and the Banner Health System. Knowledge, Skills, and Abilities: Must possess excellent interpersonal skills to interact with patients and co-workers. Attention to detail and ability to organize. Ability to work in a clinical setting. Ability to work independently and in a team.

Ability to maneuver multiple tasks at once. Knowledge of CERNER, On. Core, Red. Cap, IRB.