Research Assistant

Flourish Research•Denver, CO

7d•Onsite

About The Position

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 Research Assistant to support our Valkyrie Clinical Trials Denver, Colorado site. The Research Assistant (RA) supports the activities, duties, and procedures required for the start-up, conduct, and close-out of oncology clinical trial protocols at Valkyrie Clinical Trials. Working under the direction of a Clinical Research Coordinator (CRC) or Team Lead, the role helps obtain clean, objective, and accurate data within sponsor timelines while protecting participant safety and maintaining inspection-ready documentation. Two things distinguish this role beyond standard clinical support. Oncology protocols are clinically dense, so building real familiarity with the state of the disease, treatment history, and clinical rationale behind each assigned protocol, not just the task list, is part of the job from day one. In this patient population, a missed detail is a safety issue before it's ever a data issue. Valkyrie's care model is also white glove. Participants and their families are never routed around or told no when they hit a logistical obstacle, and the RA is expected to help remove those barriers, escalating to the CRC or Team Lead when a resolution is beyond their current scope. This is the individual contributor entry point into the Clinical Research Coordinator job family. The band spans Research Assistants who are new to clinical research through Senior Research Assistants operating with greater independence and taking on more complex protocol responsibilities. Progression through the band, and eventual readiness for the CRC role, is determined by the Flourish Research CRC Competency Assessment. All work is performed in accordance with Flourish Research SOPs, policies and procedures, federal regulations, medical ethics, Good Clinical Practice, ICH guidelines, IRB requirements, sponsor protocol requirements, and the Flourish Research Core Values, Mission Statement, and Employee Manual.

Requirements

Bachelor's degree in a life sciences major preferred (i.e. Biology, Nursing, Healthcare Administration or related field), or equivalent experience in clinical research.
Preferably a minimum of 1-3+ years' experience within the field of clinical research or biological research.
Exceptional knowledge of clinical research methods.
Demonstrates core values and all skills set required.
Demonstrated ability to collaborate and align with all research department teams.
Excellent oral and written communication skills.
Excellent computer skills to include Office 365 products.
Is moral and ethical in decision-making and during interaction with patients, sponsor and IRB representatives, physicians and staff at satellite clinics, and other employees.
Must be professional, have a strong work ethic, be motivated to identify tasks that need to be completed, and strive for accuracy and quality when completing assignments.
ECG, phlebotomy skills, and any other technical skills related to the completion of a study visit as required by the protocol.
Must be able to adapt and take on additional tasks as requested.
Assists with key initiatives/process improvements in the department.
Assists with training company new hires.
Completes at least 80% of goals annually.

Nice To Haves

Oncology clinical research experience is a plus.

Responsibilities

Read and understand protocols to help accomplish protocol-specified patient visits and procedures as directed by assigned Team Lead or CRC.
Under the direction of assigned Team Lead or CRC and after completion of required training, clearly and concisely document patient assessments, observations, test results, and other study-related information per federal regulations, protocol requirements, and GCPs.
Obtain patient informed consent according to federal regulations, GCPs, and IRB requirements.
Assist in the creative and diligent recruitment of qualified study subjects into assigned protocols to fulfill enrollment obligations within the sponsor's timeline while following regulations and rules governing medical ethics, IRB, and GCP guidelines.
Assist in the scheduling, preparation, and conducting of patient visits according to protocol requirements and timelines as directed by assigned Team Lead or CRC.
Under close supervision, maintain accurate and complete written source documentation of patient visits and protocol-related activities.
Accurately complete case report forms (CRFs) and/or worksheets generated by the sponsor or CRO.
Maintain confidentiality of patient and/or protocol issues as appropriate and as bound by Confidentiality Agreements, including but not limited to those with Flourish Research, between Flourish Research and sponsors, and between Flourish Research and other entities.
Promptly report adverse events to the Team Lead, CRC, or other supervisor and/or Principal Investigator/Sub-Investigator as deemed necessary.
Assist in the accountability of clinical trial materials (i.e., CRFs, study drug, lab supplies, and/or other required items) and help ensure availability of appropriate quantities required for the study.
Maintain ongoing communication with the Team Lead, CRC, Clinical Team Manager, Principal Investigator, and other persons assisting with the study, and document these communications according to protocol requirements and Flourish Research policies.
Attend required training courses/conferences to stay current and aware of changing federal regulations and Flourish Research 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 Flourish policies.
Perform all duties in a safe and prudent manner.
Represent Flourish Research in a professional and courteous manner (verbal, written, and in appearance) when interacting with Flourish staff, sponsors, IRBs, patients/subjects, and nursing and medical staff members of various clinics, hospitals, and physicians' offices.
Additional duties as assigned by management.