Clinical Research Regulatory Coordinator

Job Description 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. 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 are actively hiring a Clinical Research Coordinator to support our Valkyrie Clinical Trials Denver, Colorado site. Monday to Friday, Day Shift, 40 hours per week 27-44 per hour (depending on experience) Clearly and concisely document patient assessments, treatments, observations, test results and other study related information per federal regulations, protocol requirements and GCP Guidelines. 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. 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. 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. Team Manager/Research Manager; 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. 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 medical staff members of various clinics, hospitals, and physician’s offices. Physical Requirements And/Or Environmental Factors Work is normally performed in a typical interior/office work environment. Travel required but minimal. Laboratory processing procedures. Daily computer use. Occasional night and weekend work schedules. Bachelor's Degree Preferred But Not Required. Bachelor's degree preferred; Clinical research certification is a plus A minimum of 1-3 years’ clinical research experience, with at least 1 year in oncology. Experience in early phase oncology research preferred. Exceptional knowledge of clinical research methods. Demonstrated ability to collaborate and align with operations. Excellent computer skills to include Office365 products. Experience in writing and reviewing Standard Operating Procedures. Strong problem solving, risk assessment and impact analysis abilities. Demonstrated experience in process improvement. Flexible and able to multi-task and prioritize competing demands. Identifies and implements process improvements for increased efficiency. Serves as preceptor, mentor and subject matter expert in department. Must have industry certification, as applicable by Valkyrie Clinical Trials. Flourish Research offers an excellent comprehensive benefits package to include: Health, dental, and vision insurance plans, 401(k) with a 100% employer match on the first 4% of employee contributions, tuition reimbursement, parental leave, employee referral program, employee assistance program, life insurance, disability insurance, and a generous PTO plan covering vacation, sick, personal days and 8 paid holidays. Flourish Research is an equal employment opportunity employer. Employment decisions are based on merit and business needs, and not on race, color, sex, (including pregnancy and gender identity), citizenship status, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, genetic information, marital status, veteran status, political affiliation, or any other factor protected by law. Flourish Research complies with the law regarding reasonable accommodation for handicapped and disabled employees. #J-18808-Ljbffr Flourish Research