Senior Clinical Research Coordinator

Valkyrie Clinical Trials (VCT), a Flourish Research Company, is a leading Oncology multi-site clinical research network with expertise in Oncology research. VCT approaches clinical research with a deep sense of humanity, compassion, and sincere kindness. VCT was founded by leading Clinical Oncologist, Dr. David Berz, and has multiple sites spanning California in Century City, Panaroma City, and Murrieta, and has recently expanded to Denver, Colorado.

Flourish Research is one of the industry’s most progressive and diversified clinical trial organizations, with strong capabilities across cardiology, metabolic disorders, renal, oncology, CNS, pulmonology, and vaccine research. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU! 

We are actively hiring a Senior Clinical Research Coordinator to support our Valkyrie Clinical Trials Denver, Colorado site.

LOCATION: Onsite
FLSA: Non-Exempt
HOURS: Monday to Friday, Day Shift, 40 hours per week
COMPENSATION: $34-$39 per hour (depending on experience)

Requirements

ESSENTIAL JOB FUNCTIONS:

• Read, understand, and  ensure the completion of all protocol required patient visits and procedures 
• Clearly and concisely document patient assessments, treatments, observations, test results and other study related information per federal regulations, protocol requirements and GCP Guidelines. 
• Obtain patient informed consent, and reconsent as��required, according to federal regulations, GCP and IRB requirements while educating patients on study requirements, timelines, and visit expectations. 
• As Senior CRC, lead and mentor other research staff and serve as an escalation point and SME. 
• Is diligent in enrolling qualified study  participants  into appropriate protocols  within the sponsor’s timeline while following regulations and rules governing medical ethics, IRB, GCP and ICH guidelines. 
• Complete all required training in a timely manner. 
• Schedule and conduct patient visits according to protocol requirements and timelines. 
• Maintain  written source documentation of patient visits and protocol related activities per ALCOA guidelines 
• Accurately complete case report forms (CRFs &/or eCRFs) and/or worksheets and respond to queries generated by the sponsor  in a timely manner 
• Maintain confidentiality of all patient and protocol activities and information as appropriate and as bound by Confidentiality Agreements with Valkyrie/Flourish Research, between Valkyrie/Flourish and sponsors, and between Valkyrie/Flourish and other entities, as well as HIPAA regulations. 
• Promptly document and report adverse events to supervisor and/or Principal Investigator/Sub-Investigator as deemed necessary. 
• Report Serious Adverse Events (SAEs) to sponsor within 24 hours of becoming aware of the SAE. Also report the SAE to the supervisor, Principal Investigator and/or Sub-Investigator immediately. 
• Account for clinical trial materials (i.e., CRFs, study drug, lab supplies, and/or other required items) and ensure availability of appropriate amounts for the conduct of the study. 
• Maintain ongoing communication with Team Lead I; Team Manager/Research Manager; Principal Investigator; Sub-Investigators and other people assisting with the trial and documenting these communications according to protocol requirements and Valkyriepolicies. 
• Attend required training courses/conferences in order to stay abreast of current and changing federal regulations and Valkyrie policies. 
• Pursue educational opportunities to increase knowledge of the research process and associated rules and regulations governing clinical research. 
• Attend Investigator Meetings, SIVs, team meetings, and/or other trainings as directed. 
• Perform all study-related duties in a time- and cost-effective manner in adherence with Valkyrie,  policies. 
• Represent Valkyrie, Clinical Trials in a professional and courteous manner (verbal, written and in appearance) when interacting with Valkyrie  staff, sponsors, IRBs, patients/participants, nursing and me